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Completed

NCT Number: NCT03446716

Sleep Extension and Behavior of Young Children

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts

Amherst, Massachusetts, 01003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Extension

Behavioral

Child attempted to go to bed 90 mins in advance of their normal bedtime.

Primary outcomes

  1. total sleep time

    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)

    average nightly across 5 nights

Secondary outcomes

  1. inhibitory control

    Time frame: measured before and after sleep - about 12 hrs

    measured with the Go/NoGo task

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2018
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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