Back to resultsSleep Extension and Behavior of Young Children
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Extension
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- A subset of children were required to have an ADHD diagnosis
Exclusion Criteria:
- diagnosis of intellectual disabilities or developmental delay
- current diagnosis of history of sleep disorder
- uncorrected hearing or visual impairments
Sites / Locations
- University of Massachusetts
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EXTENSION
CONTROL
Arm Description
During the extension condition, caregivers were instructed to put their child to bed 90 minutes earlier than their habitual bedtime for five consecutive nights. Caregivers were provided a list of tips to aid in implementing the earlier bedtime.
Children followed their normal bedtime routine for five consecutive nights.
Outcomes
Primary Outcome Measures
total sleep time
average nightly across 5 nights
Secondary Outcome Measures
inhibitory control
measured with the Go/NoGo task
Full Information
NCT ID
NCT03446716
First Posted
February 12, 2018
Last Updated
February 20, 2018
Sponsor
University of Massachusetts, Amherst
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03446716
Brief Title
Sleep Extension and Behavior of Young Children
Official Title
Effects of Sleep Extension on Sleep Physiology and Behavior of Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pseudo-randomized intervention study examined change in inhibitory control following a sleep manipulation in which children with and without ADHD were instructed to advance their bedtime by 90 minutes for five days.
Detailed Description
Objective: To evaluate the efficacy of a sleep extension intervention in young children with ADHD and determine whether sleep extension improves inhibitory control, a primary deficit in ADHD.
Design: Children with and without ADHD completed two 5-day assessments: a baseline condition in which children followed their normal bedtime routine and a sleep extension condition in which children were instructed to go to bed 90 minutes earlier than their habitual bedtime. Sleep was assessed with actigraphy and, on the final night, polysomnography. A Go/No-Go task was used to assess inhibitory control.
Setting: Participants slept in their home on nights 1-4 and in the sleep laboratory on night 5 of each condition.
Main Outcomes and Measures: Of interest is actigraph measurement of total sleep time for the baseline compared to the sleep extension condition. Polysomnography will be used to compared changes in sleep physiology. The primary behavioral outcome is inhibitory control, indexed by accuracy on No-Go trials in the Go/No-Go task.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to the ADHD or Typically Developing group based on diagnosis history. Each then completes the intervention (EXTENSION) either preceded or followed by a week of baseline sleep (CONTROL). The order is pseudo-randomized.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXTENSION
Arm Type
Experimental
Arm Description
During the extension condition, caregivers were instructed to put their child to bed 90 minutes earlier than their habitual bedtime for five consecutive nights. Caregivers were provided a list of tips to aid in implementing the earlier bedtime.
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Children followed their normal bedtime routine for five consecutive nights.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Extension
Intervention Description
Child attempted to go to bed 90 mins in advance of their normal bedtime.
Primary Outcome Measure Information:
Title
total sleep time
Description
average nightly across 5 nights
Time Frame
5 days (actigraph watch is worn for 5 days in each condition and overnight sleep time is identified and averaged across these 5 days)
Secondary Outcome Measure Information:
Title
inhibitory control
Description
measured with the Go/NoGo task
Time Frame
measured before and after sleep - about 12 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A subset of children were required to have an ADHD diagnosis
Exclusion Criteria:
diagnosis of intellectual disabilities or developmental delay
current diagnosis of history of sleep disorder
uncorrected hearing or visual impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Spencer, PhD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sleep Extension and Behavior of Young Children
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