NCT05078112

Sleep Device Testing to Promote Sleep in Infants

Completed NA Results posted Last updated 15 October 2024

What this trial tests

NA trial testing Sleep sensor technology in Insomnia Chronic in 19 participants. Completed in 31 July 2022.

Timeline

20 October 2021

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	20 October 2021
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Sleep sensor technology

Conditions studied

• Insomnia Chronic — all drugs for Insomnia Chronic →

Sponsor

Duke University

Who can join

Adults 2 Months to 12 Months, any sex, with Insomnia Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary Primary · 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.

Group	Value	95% CI
Sleep Device Intervention	-0.88	± 0.89

Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score Secondary · 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.

Group	Value	95% CI
Sleep Device Intervention	13.4	± 10.6

Change in Caregiver Epworth Sleepiness Scale (ESS) Secondary · 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.

Group	Value	95% CI
Sleep Device Intervention	-0.94	± 2.95

Change in Patient Health Questionnaire-2 (PHQ-2) Score Secondary · 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.

Group	Value	95% CI
Sleep Device Intervention	-0.47	± 1.16

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.