Sleep Extension and Behavior of Young Children

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Effects of Sleep Extension on Sleep Physiology and Behavior of Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446716
• Other study ID #: 2015-2739
• Secondary ID: R01HL111695
• Status: Completed
• Phase: N/A
• First received: February 12, 2018
• Last updated: February 20, 2018
• Start date: December 1, 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: February 2018
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• Sleep Extension
Child attempted to go to bed 90 mins in advance of their normal bedtime.

Locations

Country	Name	City	State
United States	University of Massachusetts	Amherst	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total sleep time	average nightly across 5 nights	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	inhibitory control	measured with the Go/NoGo task	measured before and after sleep - about 12 hrs