CompletedNot Applicable

Sleep Device Testing to Promote Sleep in Infants

United States19 participantsStarted 2021-10-20

Plain-language 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.

Who can participate

Age range2 Months – 12 Months

SexALL

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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.

What they're measuring

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

Timeframe: Baseline to 5 days post-intervention

Trial details

NCT IDNCT05078112

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-31

Results submitted2023-07-24

View on ClinicalTrials.gov More Insomnia Chronic trials