WatchPAT Device Validation Study Compared to Polysomnography

Study Overview
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Brief Summary
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Validation study of a novel sleep Device compared to a traditional sleep study.

Detailed Description
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This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.

Official Title
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Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age

Conditions
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Sleep Apnea Syndromes, Sleep Disorder, Sleep

Intervention / Treatment
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* Device: WatchPAT Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 5 through 12 years of age. Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as: snoring, witnessed apneas, daytime sleepiness, and mouth breathing, etc. Informed consent obtained. Exclusion Criteria: Medical conditions that can affect the tonometer reading such as: peripheral vascular disease, cyanotic heart disease, systemic hypertension, and sickle cell crisis. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as: autism spectrum disorder, Trisomy 21, and neurodevelopmental disorders. History of neuromuscular malformation History of current supplemental oxygen use History of current vasoactive, cardiac or seizure medication use Inability or unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 4 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WatchPAT Intervention<br>Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). | Device: WatchPAT Intervention<br>* Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) | Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more. | Up to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) | Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep. | Up to 10 hours | 
| Oxygen Desaturation Index (ODI) | Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour. | Up to 10 hours | 
| Sleep Staging: Light and Deep | Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM). | Up to 10 hours | 
| Oxygen Saturation | Amount of oxygen present in the subjects blood via pulse oximetry. | Up to 10 hours | 
| Heart Rate | Documentation of the Subjects heart rate. | Up to 10 hours | 
| Body Position | Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc. | Up to 10 hours | 
| Sleep Time (Total) | The Total Sleep Duration time in minutes as recorded by the PSG. | Up to 10 hours | 
| Sleep Staging: REM | Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM). | Up to 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polysomnogram, Sleep Disordered Breathing