Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model

Andy C Y Tse, Paul H Lee, Jihui Zhang, Elvis W H Lai, Andy C Y Tse, Paul H Lee, Jihui Zhang, Elvis W H Lai

Abstract

Introduction: Sleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels.

Methods and analysis: All eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant's melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018.

Ethics and dissemination: Ethical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer-reviewed journals.

Trial registration number: NCT03348982.

Keywords: children with autism spectrum disorders; melatonin; physical activity; sleep.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Flow chart of the proposed study.

References

    1. World Health Organization. Questions and answers about autism spectrum disorders (ASD). 2016. (accessed 12 Aug 2016).
    1. Rapin I, Tuchman RF. Autism: definition, neurobiology, screening, diagnosis. Pediatr Clin North Am 2008;55:1129–46. 10.1016/j.pcl.2008.07.005
    1. Yip L. Update on autism. Public Health Epidemiol Bull 2012;21:11–16.
    1. Cortesi F, Giannotti F, Ivanenko A, et al. . Sleep in children with autistic spectrum disorder. Sleep Med 2010;11:659–64. 10.1016/j.sleep.2010.01.010
    1. Liu X, Hubbard JA, Fabes RA, et al. . Sleep disturbances and correlates of children with autism spectrum disorders. Child Psychiatry Hum Dev 2006;37:179–91. 10.1007/s10578-006-0028-3
    1. Sivertsen B, Posserud MB, Gillberg C, et al. . Sleep problems in children with autism spectrum problems: a longitudinal population-based study. Autism 2012;16:139–50. 10.1177/1362361311404255
    1. Orsmond GI, Seltzer MM. Siblings of individuals with autism spectrum disorders across the life course. Ment Retard Dev Disabil Res Rev 2007;13:313–20. 10.1002/mrdd.20171
    1. Goldman SE, Richdale AL, Clemons T, et al. . Parental sleep concerns in autism spectrum disorders: variations from childhood to adolescence. J Autism Dev Disord 2012;42:531–8. 10.1007/s10803-011-1270-5
    1. Fricke-Oerkermann L, Plück J, Schredl M, et al. . Prevalence and course of sleep problems in childhood. Sleep 2007;30:1371–7. 10.1093/sleep/30.10.1371
    1. Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, et al. . Prevalence of insomnia symptoms in a general population sample of young children and preadolescents: gender effects. Sleep Med 2014;15:91–5. 10.1016/j.sleep.2013.08.787
    1. Souders MC, Mason TB, Valladares O, et al. . Sleep behaviors and sleep quality in children with autism spectrum disorders. Sleep 2009;32:1566–78. 10.1093/sleep/32.12.1566
    1. Richdale AL, Schreck KA. Sleep problems in autism spectrum disorders: prevalence, nature, & possible biopsychosocial aetiologies. Sleep Med Rev 2009;13:403–11. 10.1016/j.smrv.2009.02.003
    1. Dewald JF, Meijer AM, Oort FJ, et al. . The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: a meta-analytic review. Sleep Med Rev 2010;14:179–89. 10.1016/j.smrv.2009.10.004
    1. Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev 2006;10:323–37. 10.1016/j.smrv.2005.11.001
    1. Mazurek MO, Sohl K. Sleep and behavioral problems in children with autism spectrum disorder. J Autism Dev Disord 2016;46:1906–15. 10.1007/s10803-016-2723-7
    1. Schreck KA, Mulick JA, Smith AF. Sleep problems as possible predictors of intensified symptoms of autism. Res Dev Disabil 2004;25:57–66. 10.1016/j.ridd.2003.04.007
    1. Doo S, Wing YK. Sleep problems of children with pervasive developmental disorders: correlation with parental stress. Dev Med Child Neurol 2006;48:650–5. 10.1017/S001216220600137X
    1. Xt Y, Lam HS, Ct A, et al. . Extended parent-based behavioural education improves sleep in children with autism spectrum disorder. Hong Kong J Ped 2015;20:219–25.
    1. Richdale AL. Sleep problems in autism: prevalence, cause, and intervention. Dev Med Child Neurol 1999;41:60–6. 10.1017/S0012162299000122
    1. Malow BA, Byars K, Johnson K, et al. . A practice pathway for the identification, evaluation, and management of insomnia in children and adolescents with autism spectrum disorders. Pediatrics 2012;130(Suppl 2):S106–S124. 10.1542/peds.2012-0900I
    1. Bramble D. Consumer opinion concerning the treatment of a common sleep problem. Child Care Health Dev 1996;22:355–66. 10.1111/j.1365-2214.1996.tb00438.x
    1. Vriend JL, Corkum PV, Moon EC, et al. . Behavioral interventions for sleep problems in children with autism spectrum disorders: current findings and future directions. J Pediatr Psychol 2011;36:1017–29. 10.1093/jpepsy/jsr044
    1. Weiskop S, Richdale A, Matthews J. Behavioural treatment to reduce sleep problems in children with autism or fragile X syndrome. Dev Med Child Neuro 1999;47:94–104. 10.1111/j.1469-8749.2005.tb01097.x
    1. Lancioni GE, O’Reilly MF, Basili G. Review of strategies for treating sleep problems in persons with severe or profound mental retardation or multiple handicaps. Am J Mental Retard 1999;104:170–86. 10.1352/0895-8017(1999)104<0170:ROSFTS>;2
    1. Driver HS, Taylor SR. Exercise and sleep. Sleep Med Rev 2000;4:387–402. 10.1053/smrv.2000.0110
    1. Kredlow MA, Capozzoli MC, Hearon BA, et al. . The effects of physical activity on sleep: a meta-analytic review. J Behav Med 2015;38:427–49. 10.1007/s10865-015-9617-6
    1. Youngstedt SD, O’Connor PJ, Dishman RK. The effects of acute exercise on sleep: a quantitative synthesis. Sleep 1997;20:203–14. 10.1093/sleep/20.3.203
    1. Lundahl A, Nelson TD, Van Dyk TR, et al. . Psychosocial stressors and health behaviors: examining sleep, sedentary behaviors, and physical activity in a low-income pediatric sample. Clin Pediatr 2013;52:721–9. 10.1177/0009922813482179
    1. Stone MR, Stevens D, Faulkner GE. Maintaining recommended sleep throughout the week is associated with increased physical activity in children. Prev Med 2013;56:112–7. 10.1016/j.ypmed.2012.11.015
    1. Wachob D, Lorenzi DG. Brief report: influence of physical activity on sleep quality in children with autism. J Autism Dev Disord 2015;45:2641–6. 10.1007/s10803-015-2424-7
    1. Brand S, Jossen S, Holsboer-Trachsler E, et al. . Impact of aerobic exercise on sleep and motor skills in children with autism spectrum disorders - a pilot study. Neuropsychiatr Dis Treat 2015;11:1911–20. 10.2147/NDT.S85650
    1. McGinty D, Szymusiak R. Keeping cool: a hypothesis about the mechanisms and functions of slow-wave sleep. Trends Neurosci 1990;13:480–7. 10.1016/0166-2236(90)90081-K
    1. Adam K, Oswald I. Protein synthesis, bodily renewal and the sleep-wake cycle. Clin Sci 1983;65:561–7. 10.1042/cs0650561
    1. Atkinson G, Edwards B, Reilly T, et al. . Exercise as a synchroniser of human circadian rhythms: an update and discussion of the methodological problems. Eur J Appl Physiol 2007;99:331–41. 10.1007/s00421-006-0361-z
    1. Lee H, Kim S, Kim D. Effects of exercise with or without light exposure on sleep quality and hormone reponses. J Exerc Nutrition Biochem 2014;18:293–9. 10.5717/jenb.2014.18.3.293
    1. Wirojanan J, Jacquemont S, Diaz R, et al. . The efficacy of melatonin for sleep problems in children with autism, fragile X syndrome, or autism and fragile X syndrome. J Clin Sleep Med 2009;5:145–50.
    1. Rossignol DA, Frye RE. Melatonin in autism spectrum disorders: a systematic review and meta-analysis. Dev Med Child Neurol 2011;53:783–92. 10.1111/j.1469-8749.2011.03980.x
    1. Krakowiak P, Goodlin-Jones B, Hertz-Picciotto I, et al. . Sleep problems in children with autism spectrum disorders, developmental delays, and typical development: a population-based study. J Sleep Res 2008;17:197–206. 10.1111/j.1365-2869.2008.00650.x
    1. Veatch OJ, Goldman SE, Adkins KW, et al. . Melatonin in Children with Autism Spectrum Disorders: How Does the Evidence Fit Together? J Nat Sci 2015;1:125.
    1. Goldman SE, Adkins KW, Calcutt MW, et al. . Melatonin in children with autism spectrum disorders: endogenous and pharmacokinetic profiles in relation to sleep. J Autism Dev Disord 2014;44:2525–35. 10.1007/s10803-014-2123-9
    1. Arendt J. Importance and relevance of melatonin to human biological rhythms. J Neuroendocrinol 2003;15:427–31. 10.1046/j.1365-2826.2003.00987.x
    1. Marrin K, Drust B, Gregson W, et al. . Diurnal variation in the salivary melatonin responses to exercise: relation to exercise-mediated tachycardia. Eur J Appl Physiol 2011;111:2707–14. 10.1007/s00421-011-1890-7
    1. American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. Washington DC: American Psychiatric Association, 2016.
    1. Giannotti F, Cortesi F, Cerquiglini A, et al. . An open-label study of controlled-release melatonin in treatment of sleep disorders in children with autism. J Autism Dev Disord 2006;36:741–52. 10.1007/s10803-006-0116-z
    1. Petrus C, Adamson SR, Block L, et al. . Effects of exercise interventions on stereotypic behaviours in children with autism spectrum disorder. Physiother Can 2008;60:134–45. 10.3138/physio.60.2.134
    1. Kern L, Koegel RL, Dyer K, et al. . The effects of physical exercise on self-stimulation and appropriate responding in autistic children. J Autism Dev Disord 1982;12:399–419. 10.1007/BF01538327
    1. Centers of Disease Control and Prevention. Measuring physical activity intensity: target heart rate and estimated maximum heart rate. (accessed 26 Mar 2017).
    1. Londeree BR, Moeschberger ML. Effect of age and other factors on maximal heart rate. Res Q Exerc Sport 1982;53:297–304. 10.1080/02701367.1982.10605252
    1. Pan CY, Chu CH, Tsai CL, et al. . The impacts of physical activity intervention on physical and cognitive outcomes in children with autism spectrum disorder. Autism 2017;21:190–202. 10.1177/1362361316633562
    1. Lang R, Koegel LK, Ashbaugh K, et al. . Physical exercise and individuals with autism spectrum disorders: a systematic review. Res Autism Spectr Disord 2010;4:565–76. 10.1016/j.rasd.2010.01.006
    1. Owens JA, Spirito A, McGuinn M. The Children’s Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep 2000;23:1–9. 10.1093/sleep/23.8.1d
    1. Barreira TV, Schuna JM, Mire EF, et al. . Identifying children’s nocturnal sleep using 24-h waist accelerometry. Med Sci Sports Exerc 2015;47:937–43. 10.1249/MSS.0000000000000486
    1. ActiGraph. What is MVPA and how I can view in ActiLife. 2016. (accessed 2 Sep 2017).
    1. Schernhammer ES, Kroenke CH, Dowsett M, et al. . Urinary 6-sulfatoxymelatonin levels and their correlations with lifestyle factors and steroid hormone levels. J Pineal Res 2006;40:116–24. 10.1111/j.1600-079X.2005.00285.x
    1. Efird J. Blocked randomization with randomly selected block sizes. Int J Environ Res Public Health 2011;8:15–20. 10.3390/ijerph8010015
    1. Kline CE, Crowley EP, Ewing GB, et al. . The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep 2011;34:1631–40. 10.5665/sleep.1422

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner