Sleep Device Testing to Promote Sleep in Infants

Duke University

Status: Completed

Conditions: Insomnia Chronic

Treatments: Device: Sleep sensor technology

Study type: Interventional

Funder types: Other

Identifiers

NCT05078112

Pro00103800

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 2 to 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Sleep Device intervention

Experimental group

Description:

Infants will utilize the sleep device during sleep for 20 days

Treatment:

Device: Sleep sensor technology