Sleep Device Testing

Clinical Testing of a Novel Device to Promote Sleep Continuity 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.

Study Overview

• Status: Completed
• Conditions: Insomnia Chronic
• Intervention / Treatment: Device: Sleep sensor technology

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 4-12 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Device intervention; Infants will utilize the sleep device during sleep for 20 days	Device: Sleep sensor technology; Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output based on historical sleep data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of total discrete crying episodes as measured by parent sleep diary	Parents will fill out sleep diaries to track changes over the duration of the study	1 month
Number of discrete crying episodes between time asleep and time awake as measured by parent sleep diary	Parents will fill out sleep diaries to track changes over the duration of the study	1 month
Number of minutes of crying at night (total) as measured by sleep device report	Sleep device tracks crying through a microphone.	1 month
Number of minutes of crying between time asleep and time awake as measured by sleep device report	Sleep device tracks crying through a microphone.	1 month
Number of minutes of quiet wakefulness as measured by sleep device report	Sleep device tracks crying and wakeful through a microphone and accelerometer.	1 month
Number of minutes of quiet wakefulness between time asleep and time awake as measured by sleep device report	Sleep device tracks crying and wakeful through a microphone and accelerometer.	1 month
Number of minutes of wakefulness as measured by parent sleep diary	Parents will fill out sleep diaries to track changes over the duration of the study	1 month
Number of minutes of wakefulness between time asleep and time awake as measured by parent sleep diary	Parents will fill out sleep diaries to track changes over the duration of the study	1 month
Total length of time asleep as measured by parent sleep diary	Parents will fill out sleep diaries to track changes over the duration of the study	1 month
Total length of time in bed as measured by parent sleep diary	Parents will fill out sleep diaries to track changes over the duration of the study	1 month

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sujay Kansagra, MD, Duke

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Pro00103800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No