COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02812368
Recruitment Status : Withdrawn (Failure to recruit)
First Posted : June 24, 2016
Last Update Posted : February 2, 2017
Autism Treatment Network
Autism Intervention Research Network on Physical Health
Information provided by (Responsible Party):
Jill Hollway, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Clonidine Drug: Placebo (for clonidine) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Clonidine
Taken once a day at bedtime; with the dose titrated from 0.05mg to 0.20mg over the course of 6 weeks
Drug: Clonidine
Other Name: Catapres, Kapvay, Duraclon

Placebo Comparator: Placebo (for clonidine)
Taken once a day at bedtime
Drug: Placebo (for clonidine)
Placebo pill manufactured to mimic clonidine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • outpatients between 6-14 years of age, inclusive, from underserved populations (i.e., Low SES, racial and ethnic minorities, rural populations);
  • diagnosis of Autism Spectrum Disorder based on DSM-V criteria and the ATN assessment protocol;
  • mental age ≥ 24 months as determined by the Stanford Binet-Fifth Edition (SB-5) or Mullen Scales of Early Learning (MSEL) (the child must be of a mental age to understand the BI/SH protocol);
  • significant sleep disturbance as determined the CSHQ 33-item Total Score of ≥ 48 and one of the following for the past four weeks by parent interview;

    1. ≥ 30 minutes delayed sleep onset, ≥ 3 times per week
    2. Sleep association problems, ≥ 3 nights per week, child falls asleep in a location other than his/her bed and requires parental intervention to return to his/her bed
    3. Nighttime Awakenings, ≥ 3 times per week, and child disturbs parent or enters into the parents' bedroom.
    4. Early Morning Awakenings, before 5 am ≥ 3 times per week and the child disturbs family members
  • CGI Severity rating of ≥ 4 (Moderate) by the independent evaluator for sleep onset and/or sleep maintenance disruption at BL 2;
  • care provider who can reliably bring subject to clinic visits and provide trustworthy ratings;
  • stable dose of psychotropic medications (for at least 4 weeks with no plans to change over the course of the study);
  • anticonvulsant if used for mood lability and it is working well;
  • stable dose of exogenous melatonin for at least 4 weeks with no plans to change over the course of the study, as long as Phase II eligibility criteria are met prior to enrollment;
  • sleep hygiene education responders who have relapsed and meet the Phase II study eligibility criteria

Exclusion Criteria:

  • DSM-V diagnosis of bipolar disorder;
  • subjects who are either melatonin naïve or who have not had an adequate trial of exogenous melatonin (defined as 3-5 mg for ≥ 4 weeks);
  • seizure disorder/epilepsy;
  • significant physical illness (e.g., serious cardiovascular, liver or renal pathology);
  • medications specifically given for insomnia;
  • pregnancy or sexually-active females without birth control;
  • taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study;
  • weight less than 15 kg;
  • use of medicines for physical ailments that might interact with CLN or TRZ, such as guanfacine (Tenex, Intuniv), and propranolol (Inderol) or extended release clonidine (Kapvay);
  • allergy to CLN or TRZ;
  • Sleep Disordered Breathing (SDB) as defined by a total score of ≥ 3 on the CSHQ SDB subscale and parent report;
  • prior adequate trial of CLN for sleep disturbance defined as at least 0.2mg q hs for 1 week;
  • prior adequate trial of TRZ for sleep disturbance defined as ≥ 50 mg/day for 1 week;
  • hyperthyroidism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02812368

Layout table for location information
United States, Ohio
Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Autism Treatment Network
Autism Intervention Research Network on Physical Health
Layout table for additonal information
Responsible Party: Jill Hollway, Assistant Professor of Research in Psychiatry, Ohio State University Identifier: NCT02812368    
Other Study ID Numbers: 2016H0181
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action