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OpenTrials
Completed

NCT Number: NCT05078112

Sleep Device Testing to Promote Sleep in Infants

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.

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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sleep sensor technology

Device

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Change in Caregiver Epworth Sleepiness Scale (ESS)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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