Sleep Extension and Behavior of Young Children

NCT ID: NCT03446716

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type BEHAVIORAL

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

CONTROL

Children followed their normal bedtime routine for five consecutive nights.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep Extension

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Spencer

Associate Professor of Psychological and Brain Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

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University of Massachusetts

Amherst, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01HL111695

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-2739

Identifier Type: -

Identifier Source: org_study_id

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