Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder
Status:
Withdrawn
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
Sleep disturbance has been reported in 44-86% of children with autism spectrum disorder (ASD)
and is the source of considerable stress for the affected individual and family. Sleep plays
a role in development and learning processes; thus, the appropriate treatment of sleep
disturbance is paramount to optimal outcomes. The empirical base for treatments to address
sleep in ASD is sparse, despite wide use of pharmacologic agents such as clonidine (CLN) to
target sleep disturbance. A randomized, controlled pilot investigation of CLN for sleep
disturbance in children with ASD will allow investigators to evaluate the feasibility of
conducting a much larger multisite trial to address the general lack of systematic data
available to guide practitioners. Subjects will be 16 children, ages 6-14 years, inclusive,
with sleep disturbance and ASD. This randomized double-blind, placebo-controlled (PBO),
parallel groups study will test the efficacy of CLN following a brief sleep hygiene
intervention. Outcome measures include: informant completed sleep questionnaires, daytime
behavior questionnaires, and actigraphy. Biomarkers for medication response will include
galvanic skin response and skin temperature. Side effects will be monitored throughout the
study.
Phase:
Phase 2
Details
Lead Sponsor:
Ohio State University
Collaborators:
Autism Intervention Research Network on Physical Health Autism Treatment Network