Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.

Detailed Description
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The purpose of the study proposed is twofold. First Investigators will test the feasibility of conducting portable sleep monitoring in school aged children using the Clevemed Sleepview (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 grams. Second, Investigators will perform a direct comparison between the results obtained with this portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep study performed at the St. Louis Children's Hospital Pediatric Sleep Center. These comparisons will be offered to the participants suspected of having sleep disordered breathing who present to the Washington University Pediatric Otolaryngology Department. Investigators will obtain the medical history and medications and results of the sleep study done at SLCH sleep lab from the medical record for research purposes.

Official Title
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Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Portable sleep monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5- to 12-years-old Parental informed consent Suspected Sleep Disordered Breathing Exclusion Criteria: Developmental delay Use of home oxygen History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism) History of tracheal surgery History of tracheal stenosis History of Nocturnal Hypoventilation History of Central Sleep Apnea Use of a Ventilatory Assist Device (e.g. Non-Invasive Positive Pressure Ventilation)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portable Sleep Monitor<br>Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir. | Device: Portable sleep monitor<br>* Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index using un-attended polysomnography | polysomnography analysis will be performed to determine if an apnea hypopnea index can be determined | greater than or equal to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of AHI | Compare apnea hypopnea index (AHI) between unmonitored polysomnography and in-laboratory polysomnography | greater than or equal to 6 hours | 
| Comparison of average SPO2 | Compare average SPO2 between unmonitored polysomnography and in-laboratory polysomnography | greater than or equal to 6 hours | 
| Comparison of average SPO2 nadir | Compare average SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography | greater than or equal to 6 hours | 
| Comparison of the McGill Oximetry Score | Comparison of the McGill Oximetry Score between unattended and inpatient polysomnography. | greater than or equal to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood OSA