Sleep Device Testing to Promote Sleep in Infants

Not Applicable

Completed

• Conditions: Insomnia Chronic
• Interventions: Device: Sleep sensor technology

• Registration Number: NCT05078112
• Lead Sponsor: Duke University

Brief Summary

Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-14
• Study Start: 2021-10-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Results First Submitted: 2023-07-24
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Results First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Age between 2-12 months.
2. Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.

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Exclusion Criteria

1. Diagnosed comorbid health problem that may disrupt sleep.
2. History of birth prior to 37 weeks gestational age.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep Device intervention	Sleep sensor technology	Infants will utilize the sleep device during sleep for 20 days

Primary Outcome Measures

Name	Time	Method
Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary	Baseline to 5 days post-intervention	Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention.

Secondary Outcome Measures

Name	Time	Method
Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score	Baseline to post-intervention (approximately 20 days)	The BISQ-SF is a research tool that measures infant sleep metrics, parental perceptions of the child's sleep, and parental behaviors. The total score is scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep.
Change in Caregiver Epworth Sleepiness Scale (ESS)	Baseline to post-intervention (approximately 20 days)	Caregivers evaluate their own sleepiness via the ESS. The ESS has a total score range of 0 to 24, where a higher score indicates greater sleepiness.
Change in Patient Health Questionnaire-2 (PHQ-2) Score	Baseline to post-intervention (approximately 20 days)	A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States