Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD

Summary

The purpose of this study is to evaluate the effect of Foquest® on sleep, using actigraphy and sleep diaries, in children aged 6-12 compared to baseline on no medication. Sleep difficulties, including prolonged sleep onset latency and decreased total sleep time have a significant negative impact on the functioning of children. In adults, sleep deprivation may result in drowsiness and yawning. However, in children, this may manifest as mood and behavioural disturbances which may even mimic the classic symptoms of ADHD; hyperactivity, poor impulse control, and inattention. This can in turn negatively affect the day to day activities of a child such as social interactions and learning. A meta-analysis in 2015 showed that stimulant medications impair sleep of children and adolescents. Some researchers have argued that stimulant medication may improve sleep. Importantly there appears to be heterogeneity in the effects of stimulant medication on sleep with some people sleeping better and some people worse after taking Foquest®. Although the randomized controlled trials done to date have demonstrated the efficacy and outlined the safety profile of Foquest, there remains some unanswered questions about the practical implications in the real-world setting. Some clinicians have raised the concern, for example, that the extended duration of Foquest, may have a negative impact on sleep. This study will evaluate the effect of Foquest® on sleep and particularly sleep latency and self and parent reported sleep restorative quality. This would be a novel study as there is no objective or subjective data on the effect of the Foquest® on sleep latency and total sleep time in children aged 6-12.

Timeline

Start

2020-12-01

Primary completion

2023-12-31

Completion

2023-12-31

Publications

• Background El Shakankiry HM. Sleep physiology and sleep disorders in childhood. Nat Sci Sleep. 2011 Sep 6;3:101-14. doi: 10.2147/NSS.S22839. Print 2011.
• Background Kidwell KM, Van Dyk TR, Lundahl A, Nelson TD. Stimulant Medications and Sleep for Youth With ADHD: A Meta-analysis. Pediatrics. 2015 Dec;136(6):1144-53. doi: 10.1542/peds.2015-1708.
• Background Faraone SV, Sergeant J, Gillberg C, Biederman J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003 Jun;2(2):104-13.
• Background Chatoor I, Wells KC, Conners CK, Seidel WT, Shaw D. The effects of nocturnally administered stimulant medication on EEG sleep and behavior in hyperactive children. J Am Acad Child Psychiatry. 1983 Jul;22(4):337-42. doi: 10.1016/s0002-7138(09)60668-3. No abstract available.
• Background Stein MA, Weiss M, Hlavaty L. ADHD treatments, sleep, and sleep problems: complex associations. Neurotherapeutics. 2012 Jul;9(3):509-17. doi: 10.1007/s13311-012-0130-0.
• Background Wigal SB, Wigal T, Childress A, Donnelly GAE, Reiz JL. The Time Course of Effect of Multilayer-Release Methylphenidate Hydrochloride Capsules: A Randomized, Double-Blind Study of Adults With ADHD in a Simulated Adult Workplace Environment. J Atten Disord. 2020 Feb;24(3):373-383. doi: 10.1177/1087054716672335. Epub 2016 Oct 17.

Drugs

Indications