Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia Chronic
- Sponsor
- Duke University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score(Baseline to post-intervention (approximately 20 days))
- Change in Caregiver Epworth Sleepiness Scale (ESS)(Baseline to post-intervention (approximately 20 days))
- Change in Patient Health Questionnaire-2 (PHQ-2) Score(Baseline to post-intervention (approximately 20 days))