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CompletedNCT03446716Updated Feb 27, 2018

Sleep Extension and Behavior of Young Children

An interventional study of Sleep Extension in Attention Deficit Hyperactivity Disorder, sponsored by University of Massachusetts, Amherst. Completed at 1 site in United States. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A subset of children were required to have an ADHD diagnosis

Exclusion criteria

Exclusion Criteria:

  • diagnosis of intellectual disabilities or developmental delay
  • current diagnosis of history of sleep disorder
  • uncorrected hearing or visual impairments
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • 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

  • No intervention
    CONTROL

    Children followed their normal bedtime routine for five consecutive nights.

Interventions

  • BehavioralSleep Extension

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

05

What researchers measure

Primary outcomes

  1. total sleep time

    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 outcomes

  1. inhibitory control

    measured with the Go/NoGo task

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

06

Study locations

1 site
  • University of Massachusetts
    Amherst, Massachusetts 01003, United States
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 20, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03446716
Lead sponsor
University of Massachusetts, Amherst
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Rebecca Spencer (Associate Professor of Psychological and Brain Sciences, University of Massachusetts, Amherst) — Principal investigator
First posted
Feb 27, 2018
Start date
Dec 1, 2015
Primary completion
Aug 1, 2017
Completion
Aug 1, 2017
Last update
Feb 27, 2018

Study contacts

Rebecca Spencer, PhD
principal investigator · University of Massachusetts, Amherst

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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