Sleep Extension and Behavior of Young Children

Effects of Sleep Extension on Sleep Physiology 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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Sleep Extension

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXTENSION; 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.	Behavioral: Sleep Extension; Child attempted to go to bed 90 mins in advance of their normal bedtime.
No Intervention: CONTROL; Children followed their normal bedtime routine for five consecutive nights.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
inhibitory control	measured with the Go/NoGo task	measured before and after sleep - about 12 hrs

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Rebecca Spencer, PhD, University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2015-2739; R01HL111695 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No