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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Recruitment Status : Withdrawn (Failure to recruit)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

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date February 2, 2017
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Clonidine for Sleep Disturbances in Children With Autism Spectrum Disorder
Official Title  ICMJE Not Provided
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Drug: Clonidine
    Other Name: Catapres, Kapvay, Duraclon
  • Drug: Placebo (for clonidine)
    Placebo pill manufactured to mimic clonidine
Study Arms  ICMJE
  • Experimental: Clonidine
    Taken once a day at bedtime; with the dose titrated from 0.05mg to 0.20mg over the course of 6 weeks
    Intervention: Drug: Clonidine
  • Placebo Comparator: Placebo (for clonidine)
    Taken once a day at bedtime
    Intervention: Drug: Placebo (for clonidine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02812368
Other Study ID Numbers  ICMJE 2016H0181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jill Hollway, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE
  • Autism Treatment Network
  • Autism Intervention Research Network on Physical Health
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP