Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.