Sleep Extension and Behavior of Young Children | NCT03446716

Studies
Sleep Extension and Behavior of Young Children

NCT03446716

Sponsor

University of Massachusetts, Amherst

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Sleep Extension

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL111695	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2015Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Aug 1, 2017Actual

First Submitted Date

Feb 12, 2018

First Submission Date that Met QC Criteria

Feb 20, 2018

First Posted Date

Feb 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2018

Last Update Posted Date

Feb 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rebecca Spencer, Associate Professor of Psychological and Brain Sciences, University of Massachusetts, AmherstPrincipal Investigator

Lead Sponsor

University of Massachusetts, AmherstOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EXTENSION	Experimental	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
CONTROL	No Intervention	Children followed their normal bedtime routine for five consecutive nights.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep Extension	Behavioral	Child attempted to go to bed 90 mins in advance of their normal bedtime.	EXTENSION

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebecca Spencer, PhD	University of Massachusetts, Amherst	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Massachusetts		Amherst	Massachusetts	01003	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 2, 2018
Reset	Apr 2, 2018

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 20, 2018	Feb 20, 2018	Prot_SAP_000.pdf

Submission Tracking

Estimated Results First Submitted Date

Mar 2, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 2, 2018			Apr 2, 2018

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.