Restless Legs Syndrome: Prevalence and Impact in Children and Adolescents The Peds REST Study Daniel Picchietti,

Richard P. Allen, Arthur S. Walters, Julie E. Davidson, Andrew Myers and Luigi Ferini-Strambi Pediatrics 2007;120;253 DOI: 10.1542/peds.2006-2767

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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright 2007 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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ARTICLE

Restless Legs Syndrome: Prevalence and Impact in Children and AdolescentsThe Peds REST Study
Daniel Picchietti, MDa, Richard P. Allen, PhDb, Arthur S. Walters, MDc, Julie E. Davidson, MPHd, Andrew Myers, PhDe, Luigi Ferini-Strambi, MDf University of Illinois and Carle Clinic Association, Urbana, Illinois; bDepartment of Neurology, Johns Hopkins University, Baltimore, Maryland; cSeton Hall University School of Graduate Medical Education and New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey; dWorldwide Epidemiology, GlaxoSmithKline R&D, Harlow, United Kingdom; ePremark Services, Crawley Down, United Kingdom; fSleep Disorders Center, Universita Vita-Salute and IRCCS H San Raffaele, Milan, Italy `
Financial Disclosure: This project was supported by GlaxoSmithKline Research and Development. Dr Picchietti receives grant support from the Carle Foundation.
a

ABSTRACT
OBJECTIVES. Restless legs syndrome, a common neurologic sleep disorder, occurs in 5% to 10% of adults in the United States and Western Europe. Although 25% of adults with restless legs syndrome report onset of symptoms between the ages of 10 and 20 years, there is very little literature looking directly at the prevalence in children and adolescents. In this rst population-based study to use specic pediatric diagnostic criteria, we examined the prevalence and impact of restless legs syndrome in 2 age groups: 8 to 11 and 12 to 17 years. METHODS. Initially blinded to survey topic, families were recruited from a large,

www.pediatrics.org/cgi/doi/10.1542/ peds.2006-2767 doi:10.1542/peds.2006-2767

This study was presented at the SLEEP 2006 meeting; June 1722, 2006; Salt Lake City, UT. Key Words restless legs syndrome, prevalence, sleep disorder, growing pains, attention-decit/ hyperactivity disorder, depression, anxiety, children, adolescents Abbreviations RLSrestless legs syndrome NIHNational Institutes of Health ADHDattention-decit/hyperactivity disorder Accepted for publication Apr 3, 2007
Address correspondence to Daniel Picchietti, MD, University of Illinois School of Medicine and Carle Clinic Association, Department of Pediatrics, 602 W University Ave, Urbana, IL 61801. E-mail: dpicchie@uiuc.edu PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright 2007 by the American Academy of Pediatrics

volunteer research panel in the United Kingdom and United States. Administration was via the Internet, and results were stratied by age and gender. National Institutes of Health pediatric restless legs syndrome diagnostic criteria (2003) were used, and questions were specically constructed to exclude positional discomfort, leg cramps, arthralgias, and sore muscles being counted as restless legs syndrome.
RESULTS. Data were collected from 10 523 families. Criteria for denite restless legs

syndrome were met by 1.9% of 8- to 11-year-olds and 2.0% of 12- to 17-yearolds. Moderately or severely distressing restless legs syndrome symptoms were reported to occur 2 times per week in 0.5% and 1.0% of children, respectively. Convincing descriptions of restless legs syndrome symptoms were provided. No signicant gender differences were found. At least 1 biological parent reported having restless legs syndrome symptoms in 70% of the families, with both parents affected in 16% of the families. Sleep disturbance was signicantly more common in children and adolescents with restless legs syndrome than in controls (69.4% vs 39.6%), as was a history of growing pains (80.6% vs 63.2%). Various consequences were attributed to restless legs syndrome, including 49.5% endorsing a negative effect on mood. Data were also collected on comorbid conditions and restless legs diagnosis rates.
CONCLUSIONS. These population-based data suggest that restless legs syndrome is prevalent and troublesome in children and adolescents, occurring more commonly than epilepsy or diabetes.

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logic sleep disorder in adults characterized by the following diagnostic criteria: an urge to move that is usually associated with unpleasant sensations, and symptoms that are worse at rest, relieved by movement, and most severe at night.1,2 Population-based studies in adults using these 4 essential diagnostic criteria for RLS found a prevalence of 5% to 10% in the United States and Western Europe.39 In 2 studies, the prevalence of moderately to severely affected adults, with 2 to 3 days per week or more of symptoms and a signicant impact on the quality of life, was 2.5%.3,10 Less extensive studies have found lower prevalence in Asian populations1113 and in India.14,15 The impact of RLS can be quite severe, with signicant adverse effects in adults on sleep,16 cognitive function,17,18 mood,19 and quality of life.3,20 Nonetheless, the condition continues to be significantly underdiagnosed.10,21 Although Ekbom22,23 reported RLS symptomatology in childhood as early as the 1940s, it was not until the mid-1990s that detailed pediatric case reports with polysomnography appeared in the literature.24,25 Other case reports and case series have followed.2635 Consensus criteria for the diagnosis of RLS in children and adolescents were published in 2003 after a workshop at the National Institutes of Health (NIH)2 and are summarized in Fig 1. The pediatric criteria evolved out of the adults RLS criteria and 2 previous versions of pediatric criteria.25,36 Two major concepts were incorporated, more difcult to achieve criteria than in adults for a denitive diagnosis in children and separate research categories for less denitive cases. The rst was agreed on to avoid overdiagnosis in children and the second to try and capture a broader spectrum of RLS in childhood for research purposes. On the basis of clinical experience and the development of better language skills in adolescents than in young children, the NIH committee decided to use the adult criteria for adolescents, although the categories of probable and possible RLS were left open as an option for research. These new pediatric RLS criteria were subsequently included in the International Classication of Sleep Disorders Diagnostic Manual (second edition).37 Work on pediatric RLS in the past 12 years has emphasized the familial occurrence of RLS, the association with periodic limb movements in sleep, and the relationship to attention-decit/hyperactivity disorder (ADHD) in some cases.38 Studies have indicated that many adults with RLS retrospectively recall that their symptoms started in childhood or adolescence. Two such reports noted onset of RLS for 25% in the 10- to 20-year-old age range.39,40 A pediatric RLS prevalence of 5.9% was found at the Mayo Clinic pediatric sleep disorders clinic,27 and another study found a prevalence of 1.3% in 12 pediatric practices.41 In addition, a study that included a question about leg restlessness at bedtime found this in 6.1% of
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ESTLESS LEGS SYNDROME (RLS) is a common neuro-

Canadian children 11 to 13 years old.42 However, no published studies have used the essential adult criteria or the pediatric consensus criteria to assess the prevalence of RLS in children and adolescents in the general population. The aims of the Peds RLS Epidemiology, Symptoms, and Treatment (Peds REST) study were to characterize the epidemiology of pediatric RLS in 2 general populations, in the United Kingdom and United States, as well as collect data on symptoms, severity, family history, impact, diagnosis rates, treatments, and comorbidities. METHODS Study Population A random selection of households identied from a large, volunteer market-research panel in the United Kingdom and United States were invited to participate in this survey. Respondents were blinded to the content of the survey before accepting the invitation, and only 1 survey was permitted per household. Those enrolled into the survey were households with 1 child in the eligible age range (8 17 years inclusive), where the eligible child was the biological child of the responding adult and where informed consent was given. When 1 child was eligible in a household, the survey child was selected randomly by using the last-birthday method.43 Figure 2 depicts the selection and enrollment process. The volunteer market-research panel consisted of 163 000 respondents in the United Kingdom and 128 000 in the United States. Members were originally enrolled into the panel through an online invitation and agreed to participate in surveys on a variety of topics such as leisure, consumer products, and health. Respondents were paid a sum equivalent to approximately $12 or 10 Euros for completing each survey. Survey Design The survey consisted of questions about RLS symptoms, the impact of symptoms on sleep and daytime function, treatment-seeking behavior, diagnoses, treatments received, comorbidities, and family history of RLS (Table 1). The survey consisted of 4 sections with the last 2 sections containing detailed questions for those who responded positively to earlier questions indicative of RLS. We stratied by age into 2 groups: 8 through 11 years, inclusive, and 12 through 17 years, inclusive. This follows US Food and Drug Administration age groupings, which are slightly different from NIH age groupings that have a break point at 13 years rather than 12 years. In the complete survey, there were 48 total questions about the 8- to 11-year-olds and 49 about the 12- to 17-year-olds. The surveys were eld tested by 6 families, each with a child or adolescent patient known to have RLS by expert evaluation. Half were in the younger age group and half in the older group. The surveys were

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FIGURE 1 NIH Workshop diagnostic criteria for RLS in children (2003). PLMS indicates periodic limb movements in sleep.

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FIGURE 2 Entry of participants into the study.

found to perform well in this sample. Where the eligible child was age 8 to 11 years old, the responding parent was asked to complete the survey with the child present for the section that contained questions about leg sensations. Where the eligible child was age 12 to 17, the sections referring to symptoms experienced, distress, and consequences were completed by the adolescent. The survey was administered online and respondents were routed automatically to relevant questions on the basis of their responses. The research was conducted from April 11 to 25, 2005. RLS Case Denition On the basis of the pediatric NIH criteria2 (Fig 1), a survey response-based algorithm for denite and probable RLS, appropriate to each of the 2 age groups, was
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developed by an expert panel (Drs Picchietti, Allen, Walters, and Ferini-Strambi). Case status was evaluated sequentially, with respondents being assessed rst for denite RLS and then for probable RLS. Where verbatim descriptors were used in the RLS denitions, the descriptors were reviewed by 3 experts (Drs Picchietti, Allen, and Walters) in a blinded fashion. The focus of this article is denite RLS. Although extensive data for probable RLS were collected, probable RLS was only included in the prevalence analysis, and there as a separate table. Additional work is planned to assess the role of probable RLS in the pediatric diagnostic scheme. Moderate-tosevere RLS was dened as RLS with symptom frequency of at least twice per week and at least moderate distress reported (on a 4-point scale: extremely, moderately, a little, or not at all).

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TABLE 1 Questionnaire Summary

Section Eligibility screen Questions Included Presence of child age 18 y and childs birth date Informed consent to participate Is responding parent the biological parent? Is child/adolescent currently present in person? Household demographics Has child or adolescent: ever experienced uncomfortable feelings or sensations in their legs and a strong urge to move the legs while sitting or lying down?a ever experienced growing painsa experienced difculty in falling asleep or staying asleep at night?a Does child or adolescent have difculties sitting or lying still in the evening or night?a Does leg movement seem to make the leg discomfort better or worse?a When do these uncomfortable feelings and the need to move to relieve them seem worst?a Are symptoms almost always caused by positional discomfort or muscle cramp?a Frequency of symptomsa Parental history of RLS Time of day of symptomsa Symptoms experienced (from list of 11)a Most troublesome symptoms (from list of 11)a Words the child has used to describe the symptoms (children only) Effect of symptoms including distress, impact on sleep, activities, etca History of medical diagnosis for . . . (from list of 17 conditions) Age at onset of symptoms Consulted a healthcare professional in previous 12 months for symptoms? Diagnosis received Treatments taken

tested by using descriptive tests (eg, 2 test statistic, Students t statistic) and condence intervals. RESULTS Survey Population Entry of participants into the study is depicted in Fig 2. Of 266 686 households invited to participate, 38 548 responded in the time frame needed to obtain an adequate sample size. Of those, 12 874 families had a child in the valid age range, 11 815 consented to participate, and 11 582 were eligible on the basis of the requirement that a biological parent complete the survey. A total of 10 523 completed the detailed survey. Thus, 4% of the total pool was sampled, and of those meeting all eligibility screens, 91% completed the survey. Of the 10 523 children and adolescents, there were 2133 girls and 2192 boys in the 8- to 11-year age range, and in the 12- to 17-year age range there were 2981 girls and 3217 boys. Of 4325 participants in the 8- to 11-year age range, 2092 were from the United Kingdom and 2233 from the United States. Of 6198 participants in the 12- to 17-year age range, 2707 were from the United Kingdom and 3491 from the United States. Because prevalence rates were not signicantly different between the United Kingdom and the United States, data were combined in each age range for analysis, except for comorbidity data, which did show signicantly different rates of comorbid diagnoses between countries. Prevalence of RLS Symptoms A total of 206 children and adolescents met the diagnostic criteria for denite RLS (Table 2). This corresponds with a prevalence of 1.9% for ages 8 to 11 years and 2.0% for ages 12 to 17 years. Of these, 27% (22 of 81) and 52% (65 of 125), respectively, reported moderate-to-severe RLS, corresponding with prevalence estimates of 0.5% and 1.0%. Criteria for probable 1 RLS were met by an additional 0.7% of 8- to 11-year-olds and 0.3% of 12- to 17-years-olds (Table 3). No signicant gender differences were found in either age group for denite or probable RLS. See Table 4 for a

Primary RLS screen

RLS characteristics

Additional questions

For age 8 to 11 years, all questions answered by biological parent with input from child. a For age 12 to 17 years, questions were answered by the adolescent directly and other questions answered by biological parent.

There were specic survey questions to exclude simple positional discomfort, leg cramps, arthralgias, and sore muscles from being counted as RLS. Analysis Analysis was conducted by using the Statistical Package for the Social Sciences software (SPSS, Inc, Chicago, IL). When appropriate, differences between groups were

TABLE 2 Prevalence of Denite RLS: Ages 8 to 17 Years

Age, y Survey Participants At Least Once per Month At Least 3 Times per Month n 64 119 183 Prevalence (95% CI) 1.5% (1.11.8) 1.9% (1.62.3) 1.7% (1.52.0) At Least Twice per Week At Least Twice per Week and Moderate-to-Severe Distressa n 22 65 87 Prevalence (95% CI) 0.5% (0.30.7) 1.0% (0.81.3) 0.8% (0.71.0)

n 811 1217 Total 4325 6198 10 523 81 125 206

Prevalence (95% CI) 1.9% (1.52.3) 2.0% (1.72.4) 2.0% (1.72.2)

n 40 89 129

Prevalence (95% CI) 0.9% (0.61.2) 1.4% (1.11.7) 1.2% (1.01.4)

CI indicates condence interval. a Moderate-to-severe RLS.

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detailed analysis of gender data for the denite RLS groups. Parents of children 8 to 11 years reported the age at which uncomfortable feelings in the legs rst appeared in their child as: 5 years old for 15%, 5 to 7 years old for 63%, and 8 years old for 22%. Symptoms Reported and Perceived Impact of RLS Descriptions of RLS For the children 8 to 11 years old, detailed descriptions of the RLS feelings were obtained because in this age range urge and a description in the childs own words, consistent with leg discomfort are required for the definite 1 category (Fig 1). Examples of the descriptions provided by participants are in Table 5. Growing Pains Children and adolescents with denite RLS were significantly more likely to report experience of growing pains compared with those who did not meet the criteria for denite or probable RLS (overall 80.6% vs 63.2%; P .001). Table 6 lists percent with a history of growing pains by age category. Distress When asked how distressing the RLS symptoms were (extremely, moderately, a little, or not at all), 22.2% (18 of 81) of responding parents of the 81 children who met denite RLS criteria reported that the symptoms were extremely distressing to their children, 32.1% (26 of 81) reported moderate distress, 39.5% (32 of 81) reported a little distress, and 6.2% (5 of 81) stated the symptoms were not at all distressing. Adolescents meeting denite RLS criteria (n 125) were asked directly about their level of distress, and 23.2% (29 of 125) reported extreme distress, 40.8% (51 of 125) moderate distress, 31.2% (39 of 125) a little distress, and 4.8% (6 of 125) no distress. Respondents were asked to select from a list the RLS symptoms that they experienced. See Fig 3A for the proportions of respondents reporting each symptom. In response to a question about which symptoms were most troublesome, adolescents with RLS reported inability to get comfortable (32.0%) and inability to stay still/

TABLE 4 Denite RLS: Gender Analysis

Age, y RLS Male 811 1217 Total 39 (48.1) 72 (57.6) 111 (53.9) Female 42 (51.9) 53 (42.4) 95 (46.1) n (%) Moderate-to-Severe RLS Male 13 (59.1) 39 (60.0) 52 (59.8) Female 9 (40.9) 26 (40.0) 35 (40.2)

Percentages are percent of male-female total. Moderate-to-severe RLS: at least twice per week and moderate-to-severe distress. All male-female differences are nonsignicant by Pearson 2.

urge to move (29.6%), whereas parents of children with RLS reported inability to get comfortable (30.9%) and pain (22.2%) to be the most bothersome to their child. Figure 3B provides symptom rates for children and adolescents with moderate-to-severe RLS, which were typically higher than all with RLS. For most symptoms there were not signicant differences between children and adolescents (Fig 3). Sleep Disturbance Children and adolescents with denite RLS were significantly more likely to have a history of difculty falling asleep or staying asleep at night, compared with those who did not meet the criteria for denite or probable RLS (overall: 69.4% vs 39.6%; P .001). Table 7 lists the percentage with difculty falling asleep or staying asleep by age category. Adolescents with denite RLS reported sleeping for a mean of 7.1 (median: 7) hours on a school night. Hours of reported sleep was not available for the 8- to 11-year-olds. Parents of 8- to 11-year-olds with denite RLS reported a mean of 2.1 (median: 2) nights of disturbed sleep per week for their children, whereas adolescents with denite RLS reported disturbed sleep with a mean frequency of 3.2 (median: 3) nights per week. This gure for adolescents is signicantly higher on average (t 4.0529; df 204; P .001) than it is for the children. A total of 83.9% of parents of children with denite RLS reported that their child, when suffering from RLS symptoms, took 30 minutes to fall asleep and would wake up on average 1.9 (SD: 1.5) times per night. A total of 77.6% of adolescents with denite RLS reported taking 30 minutes on average to

TABLE 3 Prevalence of Probable RLS: Age 8 to 17 Years

Age, y Survey Participants At Least Once per Month At Least 3 Times per Month n 22 17 39 Prevalence (95% CI) 0.5% (0.30.7) 0.3% (0.10.4) 0.4% (0.30.5) At Least Twice per Week At Least Twice per Week and Moderate-to-Severe Distressa n 6 7 13 Prevalence (95% CI) 0.1% (0.00.2) 0.1% (0.00.2) 0.1% (0.10.2)

n 811 1217 Total 4325 6198 10 523 29 18 47

Prevalence (95% CI) 0.7% (0.40.9) 0.3% (0.20.4) 0.4% (0.30.6)

n 14 14 28

Prevalence (95% CI) 0.3% (0.20.5) 0.2% (0.10.3) 0.3% (0.20.4)

CI indicates condence interval. a Moderate-to-severe RLS; met probable 1 RLS criteria.

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TABLE 5 Descriptions of Sensory Complaints: Age 8 to 11 Years

Legs need to stretch Ouchie Too much energy, I really have to move Ants crawling and aching feeling Twitchy, jerky My legs need a walk/jog Legs feel full of energy; funny feelings in the legs, aching Throbbing-ache; have the need to want to run; blood racing through legs I have to keep moving It hurts, I cant sleep; when I try my legs tingle and I hurt Legs hurt, cant go to sleep Legs hurt and feel funny She screams It hurts at bedtime Nervous, need to be jiggled Runaway legs, tweaky legs At night my legs tingle and tickle; I want to be still but if I do they hurt my feet; that is why I kick myself at night Tingly, fuzzy, pressure Tickly inside the leg Crampy, uncomfortable Fidgety, restless, too much energy My legs cant get comfortable, they want to move around on their own I feel like my legs wont be still Legs feeling giggly or jumpy They ache and feel awful He says it feels like therere bugs in his bones My legs feel funny; I want to move them; I feel frustrated; I cant sleep That her legs felt creepy crawly Like electricity owing I have a hard time falling asleep when my legs want to keep going; they feel jumpy Antsy, excited, exploding My legs feel funny, they kinda hurt and I want to move them; I cant get comfortable Feel like they want to jump off my body; make me want to run and run until I cant run any more Ticklish legs, like jumping beans I feel like I need to shake my legs like my dad does Fizzy legs; need to kick out, stretch out legs Spider in her legs
Statements are in response to question 15: What words has your child used to describe the discomfort in their legs?

Perceived Consequences Respondents were asked to select from a list of potential correlates that they thought were related to their leg discomfort (Fig 4A). For children with denite RLS, the most commonly reported consequence of RLS symptoms listed by parents was a negative inuence on the childs mood (53.1%), followed by an inability to sit still in the afternoon or evening (46.9%), and next a lack of energy (29.6%). The most frequent effect of RLS symptoms listed by adolescents with RLS was an inability to sit still in the late afternoon or evening (60.8%), followed by a negative inuence on mood (47.2%), a lack of energy (40.8%), and an inability to concentrate on schoolwork/ work (40.0%). For those with moderate-to-severe RLS, many of the reported consequences were more prevalent, including a negative inuence on mood and a lack of energy (Fig 4B). For most perceived consequences, there were not signicant differences between children and adolescents (Fig 4). RLS Diagnoses, Treatment, Family History, and Comorbid Conditions RLS Diagnoses Consulting patterns for all children and adolescents with denite RLS were investigated. Of the 81 children with denite RLS, 38 (46.9%) were reported to have had 1 medical consultation for RLS symptoms in the 12 months before the survey and of 125 adolescents with denite RLS, 64 (51.2%) reported a consultation. In response to the question What diagnosis, if any, has your child been given for these symptoms? the most common medical explanation reported as given for the RLS symptoms was the same for both children (16 of 38 consulting) and adolescents with denite RLS (29 of 64 consulting), namely that the symptoms were part of normal development (44.1%). The percentage of those whose medical consultation for RLS symptoms produced a diagnosis of RLS was 23.7% (9 of 38) for children with denite RLS and 21.9% (14 of 64) for adolescents with denite RLS. The overall rates of a medical diagnosis of RLS for all of those with denite RLS was, therefore, 11.1% (9 of 81) of children and 11.2% (14 of 125) of adolescents. Of the 22 children meeting the criteria for moderateto-severe RLS, 11 (50.0%) parents reported medical consultation about the childs symptoms in the last 12 months, and of these, 3 (27.3%) reported that the child received a diagnosis of RLS. Correspondingly, the parents of 41 of 65 adolescents (63.1%) with moderate-tosevere RLS reported that health care had been sought for the RLS symptoms in the last 12 months, with 10 (24.4%) of 41 reporting a subsequent RLS diagnosis. Thus, overall rates of medical diagnosis of RLS in the moderate-to-severe groups were: 13.6% (3 of 22) for children and 15.4% (10 of 65) for adolescents.
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get to sleep when suffering from RLS symptoms and would wake a mean of 2.5 (SD: 1.8) times a night. Daytime sleepiness was reported in 21.0% of 8- to 11-year-olds and 33.6% of 12- to 17-year-olds with denite RLS.

TABLE 6 History of Growing Pains

RLS Status Age 811 y (N n No RLS Denite RLS 2571/4215 69/81 4296) % 61.0 85.2a Age 1217 y (N n 3924/6055 97/125 6180) % 64.8 77.6b

Data are from question 2: Do they, or have they, experienced growing pains? answered by parent. Note: percentages in Table 8 are for a medical diagnosis of growing pains rather than a simple history of growing pains. a Pearson 2 for 8 to 11 years 27.214 (P .001). b Pearson 2 for 12 to 17 years 16.213 (P .001).

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FIGURE 3 A, Symptoms reported: children and adolescents with denite RLS. B, Symptoms reported: children and adolescents with moderate-to-severe RLS. a Signicant difference 8 to 11 vs 12 to 17 years at the P .05 level.

Treatment Ongoing treatment with prescription medication for children and adolescents with denite RLS was reported low, but similar: 6.2% (5 of 81) and 6.4% (8 of 125), respectively. However, in only 3 cases total (1.5%) were the medications listed those that might be considered
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appropriate in the adult RLS literature44,45: ropinirole (n 1) and codeine (n 2). Others listed for RLS treatment were amitriptyline, celecoxib, methylphenidate, amphetamine/dextroamphetamine, atomoxetine, coproxamol, and a topical antiinammatory agent. Clonidine and clonazepam were not mentioned.

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TABLE 7 Difculty Falling Asleep or Staying Asleep at Night

RLS Status Age 811 y (N n No RLS Denite RLS 1427/4215 55/81 4296) % 33.9 67.9a Age 1217 y (N n 2639/6055 88/125 6180) % 43.6 70.4b

depression, or an anxiety disorder than children or adolescents with RLS in the United Kingdom. DISCUSSION To our knowledge, this is the rst large-scale, population-based study of RLS prevalence and impact in children and adolescents and is the rst to use specic pediatric RLS denitions in a general population survey. The most important nding in this study was the high prevalence of denite RLS, 1.9% of children 8 to 11 years old and 2.0% of adolescents 12 to 17 years old. In addition, about one quarter of the children and one half of the adolescents with denite RLS met criteria for moderate-to-severe RLS. The approximate 2% prevalence in 8- to 17-year-olds exceeds that of nonfebrile seizure disorders ( 0.5%) and diabetes type 1 and 2 combined ( 1%) in this same age range, and is similar to estimates of pediatric obstructive sleep apnea ( 2%).37,46 This RLS prevalence is consistent with 7 large epidemiologic studies in adults, which have found a 5% to 10% prevalence in the United States and Western Europe,39 when adjusted for the fact that 25% of adult RLS patients reported in 2 different studies onset of RLS between 10 to 20 years old.39,40 This would give a predicted prevalence of 1.25% to 2.5%, surprisingly close to the results from this survey. The only other pediatric population-based study related to RLS that we are aware of is a longitudinal study of French-Canadian children that included a question about leg restlessness at bedtime and found 6.1% of 1353 children ages 11 to 13 years to consistently have this complaint.42 Adding in the other RLS diagnostic criteria would be expected to reduce this number appreciably. Also, it should be noted that the French-Canadian population has one of the highest reported general-population RLS prevalence rates, estimated at 15% to 20%.47,48 We found the prevalence of RLS in boys and adolescent males similar to girls and adolescent females, which is in sharp contrast to adult RLS studies that have consistently reported a 2:1 female to male ratio.4 Although our survey emphasized current symptoms, parents reported recall of onset of RLS in the 8 to 11-year-olds at 5 years of age in 15% and 5 to 7 years old in 63%, indicating that children younger than those included in our study may be affected by RLS. The descriptions of RLS feelings reported by the 8- to 11-year-olds (Table 5) provided convincing data to us that this survey did successfully measure restless legs symptomatology. Themes of bug-like sensations, ticklish feelings, electricity, jumpiness, and energy were common and are consistent with our extensive clinical experience diagnosing RLS in children and adolescents. A history consistent with RLS was reported by more than two thirds of parents of the denite RLS children and adolescents, supporting this aspect as helpful in the diagnostic criteria for RLS in children and adolescents.49 Of
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Data are from question 3: Does your child have difculty falling asleep or staying asleep? answered by parent. a Pearson 2 for 8 to 11 y 45.944 (P .001). b Pearson 2 for 12 to 17 y 35.680 (P .001).

Family History of RLS A family history of RLS was common in the denite 1 RLS group for children (n 70) and the denite RLS group for adolescents (n 125). The denite 2 RLS group for children (n 11) was not included for this analysis because the presence of a rst-degree relative with RLS is part of entry criteria for this group (Fig 1). At least 1 parent responding positively to the RLS question was found in 71.4% (50 of 70) of the denite 1 RLS children and in 80.0% (100 of 125) of the denite RLS adolescents. Both parents responding positively to the RLS question was found in 17.1% (12 of 70) and 16.0% (20 of 125) of families, respectively. Gender analysis of parental RLS found 44 mothers and 18 fathers positive for RLS of denite 1 RLS 8- to 11-year-olds, and 83 mothers and 37 fathers of denite RLS 12- to 17-yearolds, resulting in parental female to male ratios of 2.4:1 and 2.2:1, respectively. We compared children and adolescents meeting the diagnostic criteria for RLS and having a positive family history of RLS to those meeting the diagnostic criteria but having no family history RLS. There were no significant differences for sleep disturbance (question 3) or for any of the perceived consequences listed in Fig 4A (P .05). Comorbidity A question on medical history was included in the survey, and respondents were asked to select from a list which, if any, diagnoses had been received. The list consisted of diagnoses that might potentially confound, mimic, or interact with RLS (Table 8). As expected, a medical diagnosis of growing pains (29.6% of children and 36.8% of adolescents with RLS) was the most common diagnosis reported. These data on a medical diagnosis of growing pains should not be confused with the data in Table 6, which refer to a history of growing pains in response to the question Do they, or have they, experienced growing pains? answered by the parent. Other common medical diagnoses were attention-decit disorders (14.8% and 17.6%, respectively), depression (3.7% and 14.4%, respectively), and anxiety disorders (4.9% and 8.0%, respectively). Children or adolescents with RLS in the United States were more likely to have received a diagnosis for an attention-decit disorder,

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FIGURE 4 A, Perceived consequences: children and adolescents with denite RLS. B, Perceived consequences: children and adolescents with moderate-to-severe RLS. a Signicant difference 8 to 11 vs 12 to 17 years at the P .001 level; b signicant difference 8 to 11 vs 12 to 17 years at the P .05 level.

note, there were a remarkable number of families in which both parents reported RLS symptoms ( 1 of 6 families). This extra genetic load may play a role in the age of onset and severity of RLS in childhood. The increased prevalence of RLS symptoms in mothers compared with fathers is consistent with adult prevalence studies, which have shown an approximate 2:1 ratio of
262 PICCHIETTI et al

females to males.4 Parity is considered a major factor in explaining this gender difference.4 It is likely that primary and secondary RLS cases are included in our data. Although Table 8 lists 17 medical diagnoses that we asked about, we did not include a question about all active medical conditions, we did not ask about all current medications, and this large survey

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TABLE 8 Self-Reported Medical Diagnoses: Children and Adolescents With Denite RLS
% United Kingdom (N 90) 811 y (n 35) Growing painsa ADD/ADHD Depression Restless legs Anxiety disorder Insomnia Sleep disorder Anemia/iron deciency Mental disability Sleep apnea Seizures/epilepsy Nighttime cramps Spinal injury/disk problems/sciatic pain Tourettes syndrome Rheumatoid arthritis Periodic limb movement disorder Diabetes
a These

United States (N 116) 811 y (n 46) 34.8 23.9 6.5 15.2 8.7 2.2 4.3 2.2 0.0 2.2 0.0 2.2 0.0 0.0 0.0 0.0 0.0 1217 y (n 70) 42.9 28.6 15.7 12.9 12.9 11.4 7.1 5.7 7.8 5.7 2.9 2.9 2.9 2.9 0.0 0.0 0.0

United Kingdom and United States (N 206) 811 y (n 81) 29.6 14.8 3.7 9.9 4.9 1.2 4.9 2.5 1.2 1.2 0.0 2.5 0.0 0.0 0.0 0.0 0.0 1217 y (n 125) 36.8 17.6 14.4 12.0 8.0 8.0 5.6 4.8 4.8 4.8 4.0 3.2 2.4 1.6 0.8 0.0 0.0

1217 y (n 55) 29.1 3.6 12.7 10.9 1.8 3.6 3.6 3.6 1.8 3.6 5.5 3.6 1.8 0.0 1.8 0.0 0.0

22.9 2.9 0.0 2.9 0.0 0.0 5.7 2.9 2.9 0.0 0.0 2.9 0.0 0.0 0.0 0.0 0.0

data report a medical diagnosis of growing pains compared with the simple history of growing pains reported in Table 6.

did not include screening laboratory tests. Known causes of secondary RLS include renal failure, pregnancy, peripheral neuropathy, and some medications.50,51 Nonetheless, it is probable that the majority of our cases are primary RLS given the relatively low occurrence of these factors in the age range studied and the predominance of primary RLS in cases with onset before age 45.52 We did nd self-reported medical diagnoses of anemia or iron deciency, which are known aggravating factors for RLS, in 2.5% children 8- to 11-year- olds and 4.8% 12to 17-year-olds.

Growing Pains Beginning with Ekboms work on RLS in the 1940s to 1970s, there has been controversy over the relationship of growing pains to childhood RLS.23,35,53 We believe our data shed some light on this issue. A history of growing pains was common in 8- to 17-year-olds with RLS (over three quarters), but it was also common in those without RLS (almost two thirds). Although statistically signicant and useful for group data, this difference is not likely to be a key factor in the decision as to whether an individual patient has RLS. However, we have found growing pains to be a clinically useful lead-in question to a more specic discussion of RLS symptoms. Perhaps more relevant is the disparately high medical diagnosis rate of growing pains in children with RLS compared with a low medical diagnosis of RLS (Table 8), suggesting that the much more specic diagnosis of RLS was missed and that an opportunity for treatment was also missed.

Impact The impact of RLS in children and adolescents seems to be substantial. The frequency and severity of RLS feelings were reported as moderate-to-severe in about one quarter of the 8- to 11-year-olds and about half of the 12- to 17-year-olds (at least twice per week and moderately or extremely distressing). Sleep disturbance was very commonly reported in the children and adolescents meeting criteria for denite RLS, exceeding two thirds, and much more than in those without RLS (Table 7). Perceived consequences of RLS were common, with difculty sitting in the late afternoon or evening, a negative effect on mood, a lack of energy, and an inability to concentrate frequently reported in the denite RLS groups, and even more pronounced in the moderate-tosevere RLS groups (Fig 4). Given the emerging literature on the effect of sleep disturbance on cognitive and affective function in children and adolescents, these aspects are of notable concern.5460 It has been our experience that in more severe cases of pediatric RLS, treatment can be of benet. However, it should be noted that there are currently no US Food and Drug Administrationapproved treatments for RLS in children and adolescents. Diagnosis and Treatment Our data indicate that RLS is uncommonly diagnosed in children and adolescents, even for those who reported that they sought medical care for the symptoms. Less than 1 in 4 who sought medical care received an RLS diagnosis, with diagnosis rates only marginally better for
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those moderately to severely affected. Most often a medical explanation of normal development was reported. Because RLS is not generally recognized as a medically signicant disorder, there may be a tendency to discount these symptoms as unimportant or interpret them as an expression of more familiar medical conditions. In cases where medication was prescribed, only 1 of the medications reported would be considered rst-line treatment for RLS in the adult literature.1,45 Because this was a survey and not a clinical evaluation, it is possible that other diagnoses could explain the symptoms of the children and adolescents who met definite RLS criteria in our study. However, the extensive inclusion and exclusion criteria used in this study, as well as rigorous application of NIH criteria, make this unlikely in our opinion. It should be noted that the NIH denite RLS criteria in those 12 years old requires more symptoms than are required for a diagnosis in adults. This was devised to avoid overdiagnosis in children. More likely, the low medical diagnosis rates of RLS reect a lack of awareness among those providing medical care for children and adolescents. In 2 major US pediatric textbooks RLS is mentioned sparingly, a total of 2 paragraphs.46,61 Low awareness of RLS has been documented for those who provide health care for adults, although there is evidence that awareness is improving.3,21,62 Comorbidity Comorbidity of denite RLS with medically diagnosed ADHD, depression, and anxiety disorders in our study is of interest. These all were found at rates higher than diagnosis rates reported in the general pediatric population,63,64 but caution regarding these ndings is warranted given the small sample size in some of the cells. In addition, there were much lower diagnosis rates in the United Kingdom than in the United States, perhaps reecting lower occurrence but more likely because of higher diagnosis and treatment rates of some behavioral conditions in the United States than in the United Kingdom and Europe.65,66 There is considered to be a complex relationship between ADHD and sleep disorders in children, and a substantial literature exists.38,58,67,68 In adults with RLS, there are increased rates of depression,19 anxiety,69,70 and ADHD71 compared with the general population. Although various theories exist, there is some evidence that RLS and these conditions have a negative interactive effect with each other, and that their association may reect some shared common pathology.19,67 Limitations Methodologic issues should be considered in the interpretation of our results. First, the ascertainment of RLS status was by self-report via the parents or adolescents, not by clinical interview. Although it is possible that other conditions could have been reported as RLS symp264 PICCHIETTI et al

tomatology, a detailed set of questions to exclude known mimics of RLS was part of the survey. It is reassuring that there were low rates of diabetes, arthritis, and sciatic problems in the RLS cases found, because these are known confounders of the diagnosis in adults. Also, in the clinical setting the diagnosis of RLS is based on history, not requiring physical examination for a positive diagnosis. Second, our survey was conducted in a convenience sample of Internet users. United Kingdom census data suggest that 55% of households in the United Kingdom had Internet access in July 2005.72 US census data from October 2003 provided by the US Department of Commerce indicated that 55% of households in the United States had Internet access and that access was strongly associated with income.73 However, by spring 2004 the Internet usage rate was measured at 63% for adults in the United States, and the income gap was closing.74 To the extent that the prevalence of RLS, parent observation of symptoms, and health care utilization are associated with factors inuencing Internet use or propensity to volunteer in research surveys, our results, like those from all similar population studies, may be biased. Third, the 10 523 participating households represents a 4% subset of the initially invited households, which itself is a subset of the total United Kingdom and US households. To limit enrollment bias we did not disclose the specic survey topic until all eligibility criteria were met and enrollment was terminated after the 2 weeks it took to obtain an adequate sample size. Fourth, although the NIH pediatric RLS diagnostic criteria are a consensus of expert opinion, these criteria have not been validated extensively in the clinical setting. Fifth, in families where there was a parent with RLS, it is possible that those parents would have been more likely to identify the symptoms in their children inuencing the prevalence rates in familial cases. Having the adolescents complete the RLS questions directly and having the younger children present when the parent completed the questions about sensory symptoms should have reduced this type of bias. CONCLUSIONS This large, population-based study found restless legs to be quite prevalent in children and adolescents aged 8 to 17 years. Many of these children and adolescents had moderately to severely distressing symptoms and reported that RLS adversely affected both sleep and daytime function. Medical diagnosis rates of RLS were low, and treatment was uncommon. ACKNOWLEDGMENT We thank Trevor Brown of Premark, Inc, for assistance in organizing this project. REFERENCES
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Restless Legs Syndrome: Prevalence and Impact in Children and Adolescents The Peds REST Study Daniel Picchietti, Richard P. Allen, Arthur S. Walters, Julie E. Davidson, Andrew Myers and Luigi Ferini-Strambi Pediatrics 2007;120;253 DOI: 10.1542/peds.2006-2767
Updated Information & Services References including high resolution figures, can be found at: http://pediatrics.aappublications.org/content/120/2/253.full.ht ml This article cites 66 articles, 13 of which can be accessed free at: http://pediatrics.aappublications.org/content/120/2/253.full.ht ml#ref-list-1 This article has been cited by 6 HighWire-hosted articles: http://pediatrics.aappublications.org/content/120/2/253.full.ht ml#related-urls This article, along with others on similar topics, appears in the following collection(s): Neurology & Psychiatry http://pediatrics.aappublications.org/cgi/collection/neurology _and_psychiatry Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: http://pediatrics.aappublications.org/site/misc/Permissions.xht ml Information about ordering reprints can be found online: http://pediatrics.aappublications.org/site/misc/reprints.xhtml

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