Sleep Device Testing

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05078112

Collaborator

(none)

Enrollment

Location

Arm

11.4

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Chronic	Device: Sleep sensor technology	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 4-12 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Sujay Kansagra, MD, Duke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT05078112

Other Study ID Numbers:

Pro00103800

First Posted:

Oct 14, 2021

Last Update Posted:

Jul 28, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jul 28, 2022