Sleep Device Testing to Promote Sleep in Infants

Duke University19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia Chronic

Interventions

Sleep sensor technologyDEVICE

Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline to 5 days post-intervention

Secondary Outcomes

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

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.

Time frame: Baseline to post-intervention (approximately 20 days)

Change in Caregiver Epworth Sleepiness Scale (ESS)

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.

Time frame: Baseline to post-intervention (approximately 20 days)

Change in Patient Health Questionnaire-2 (PHQ-2) Score

A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia.

Time frame: Baseline to post-intervention (approximately 20 days)

Data from ClinicalTrials.gov

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