Sleep Device Testing

Insomnia Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078112
• Other study ID #: Pro00103800
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of minutes of crying at night (total) as measured by sleep device report	Sleep device tracks crying through a microphone.	1 month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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