Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730194
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Alyson Hanish, University of Nebraska

Brief Summary:
The objective of this study is to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Sleep Disturbance Dietary Supplement: Melatonin Behavioral: Bedtime Bank Not Applicable

Detailed Description:
The investigators propose to conduct a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with NDDs. SMARTs allow for a 3-arm trial offering a significant advantage in comparing interventions and combinations of interventions within a single study design. First, participants are randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute nightly increase in total sleep time [TST]) will be measured at Week 4 and 8. Participants who respond remain on the assigned treatment. Participants who are non-responsive are re-randomized to a different treatment option. To the knowledge of the investigators, a clinically meaningful increase in TST has not been reported in children. However, a nightly increase of 18 minutes in TST has been reported to improve school-performance. After a careful review of the literature, investigators chose to aim for a nightly increase of 18 minutes as a meaningful increase in TST.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: First, participants are randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute nightly increase in total sleep time [TST]) will be measured at week 4 and 8. Participants who respond remain on the assigned treatment. Participants who are non-responsive are re-randomized to a different treatment option.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin Only
Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.
Dietary Supplement: Melatonin
Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime

Experimental: Bedtime Bank Only
Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
Behavioral: Bedtime Bank
The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.

Experimental: Combination (Melatonin+Bedtime Bank)
Participants in this arm will take 3 mg melatonin 30 minutes before bedtime and utilize the Bedtime Bank, a behavioral sleep intervention.
Dietary Supplement: Melatonin
Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime

Behavioral: Bedtime Bank
The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.




Primary Outcome Measures :
  1. Actigraphy (total sleep time) [ Time Frame: To be worn daily for the entirety of the study (9 weeks total). ]
    Objective measure of sleep patterns based on the correlation between sleep-wake state and motor activity.

  2. Cleveland Adolescent Sleepiness Questionnaire (CASQ) [ Time Frame: Change from baseline CASQ score at 9 weeks. ]
    A sixteen-item instrument used to measure daytime sleepiness in adolescents 11-17 years of age.

  3. Sleep Diary [ Time Frame: Daily for the entirety of the study (9 weeks total). ]
    Participant will record time of sleep onset and time of waking up.

  4. PROMIS Pediatric Item Bank Sleep Disturbance [ Time Frame: Change from baseline PROMIS Pediatric Item Bank Sleep Disturbance score at 9 weeks. ]
    A fifteen-item questionnaire used to measure self-reported perceptions of sleep quality, depth, and restoration. This includes perceived difficulties getting to sleep and staying asleep, as well as sleep satisfaction.

  5. PROMIS Pediatric Item Bank Sleep Related Impairment [ Time Frame: Change from baseline PROMIS Pediatric Item Bank Sleep Related Impairment score at 9 weeks. ]
    A thirteen-item questionnaire used to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours.

  6. Dim Light Melatonin Onset (DLMO) [ Time Frame: To be completed once during the baseline week. ]
    The Salimetrics Salivary Melatonin Assay Kit (Carlsbad, CA) will determine Dim Light Melatonin Onset.

  7. Urinary Melatonin [ Time Frame: To be completed once during the baseline week. ]
    The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.


Secondary Outcome Measures :
  1. PROMIS Sleep Disturbance (short form v. 1.0 8b) [ Time Frame: Change from baseline PROMIS Sleep Disturbance score at 9 weeks. ]
    An eight-item questionnaire used to measure self-reported perceptions of sleep quality, depth, and restoration. This includes perceived difficulties getting to sleep and staying asleep, as well as sleep satisfaction. Parent-reported sleep.

  2. PROMIS Sleep Related Impairment (short form v. 1.0 8a) [ Time Frame: Change from baseline PROMIS Sleep Related Impairment score at 9 weeks. ]
    An eight-item questionnaire used to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours. Parent-reported sleep.



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:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 10-18 years and consistently living with parental (or legal guardian) supervision.
  • Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
  • Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ>70).
  • Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
  • Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.

Exclusion Criteria:

  • Unwillingness to stop melatonin 2 months prior to enrollment in the study.
  • Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
  • Adolescents who are not able to take oral medication.
  • Adolescents who are visually impaired with known inability to detect light.
  • Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
  • Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.

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 ClinicalTrials.gov identifier (NCT number): NCT03730194


Contacts
Layout table for location contacts
Contact: Alyson E Hanish, PhD, MSN, RN 402-559-6731 alyson.hanish@unmc.edu
Contact: Abbey J Klein, BSN, RN 402-559-6549 abbey.klein@unmc.edu

Locations
Layout table for location information
United States, Nebraska
University of Nebraska Medical Center, Center for Nursing Science Recruiting
Omaha, Nebraska, United States, 68198-5330
Contact: Alyson E Hanish, PhD, MSN, RN    402-559-6731    alyson.hanish@unmc.edu   
Principal Investigator: Alyson E Hanish, PhD, MSN, RN         
Sub-Investigator: Danielle J Stappert, BSN, RN         
Sub-Investigator: Abbey J Klein, BSN, RN         
Sponsors and Collaborators
University of Nebraska
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Alyson E Hanish, PhD, MSN, RN University of Nebraska

Publications:
Layout table for additonal information
Responsible Party: Alyson Hanish, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03730194     History of Changes
Other Study ID Numbers: 775-18-FB
1K01NR017465-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alyson Hanish, University of Nebraska:
Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Sleep Disturbance
Melatonin
ASD
ADHD
Additional relevant MeSH terms:
Layout table for MeSH terms
Autism Spectrum Disorder
Hyperkinesis
Dyssomnias
Sleep Wake Disorders
Parasomnias
Disease
Attention Deficit Disorder with Hyperactivity
Neurodevelopmental Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Child Development Disorders, Pervasive
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants