Sleep Device Testing

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Device: Sleep sensor technology


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |