Clinical Trial: Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title:

Brief 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.

Detailed Summary:
Sponsor: Ohio State University

Current Primary Outcome: Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score [ Time Frame: Change from Baseline to 6 Weeks ]

The primary outcome measure for this study is clinical improvement on the CSHQ (defined as a 30% or greater reduction in the Total Score of the 33 Sleep Items) at 6 weeks compared to baseline. The CSHQ is the most commonly used parent-rated scale to assess sleep disturbance in pediatric populations. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The CSHQ incorporates items related to eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. A Total Score of 41 or greater on the CSHQ 33 items has been reported to be an appropriate clinical cut-off for identifying sleep problems in children.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University

Dates:
Date Received: June 14, 2016
Date Started: August 2016
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017