Sleep Device Testing to Promote Sleep in Infants

NCT05078112 | Completed Results FDA Device

• 1 other identifier: Pro00103800
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 5 days post-intervention

Secondary Outcomes (3)

• 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)

Study Arms (1)

Sleep Device intervention

EXPERIMENTAL

Infants will utilize the sleep device during sleep for 20 days

Device: Sleep sensor technology

Interventions

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.

Sleep Device intervention

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Sujay Kansagra, MD
• Organization: Duke University

sujay.kansagra@duke.edu

919-668-0477

Study Officials

• Sujay Kansagra, MD

  Duke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 14, 2021
• Study Start: October 20, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)