Sleep Extension and Behavior of Young Children
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|ClinicalTrials.gov Identifier: NCT03446716|
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Behavioral: Sleep Extension||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Effects of Sleep Extension on Sleep Physiology and Behavior of Young Children|
|Actual Study Start Date :||December 1, 2015|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||August 1, 2017|
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.
- 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
- inhibitory control [ Time Frame: measured before and after sleep - about 12 hrs ]measured with the Go/NoGo task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446716
|United States, Massachusetts|
|University of Massachusetts|
|Amherst, Massachusetts, United States, 01003|
|Principal Investigator:||Rebecca Spencer, PhD||University of Massachusetts, Amherst|