Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The goal of this study is to collect raw waveform data for two separate noninvasive methods, both of which may be useful for the assessment of upper airway obstruction.

Official Title
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Assessment of a New Photoplethysmographic (PPG) Method and a Pulse Arrival Time Method to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in a Sleep Laboratory

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Measurement of PPG waveforms
* Device: Measurement of Pulse Arrival Time (PAT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients twenty-one years of age or older Exclusion Criteria: Patient refusal to participate in study Patients under 21 (twenty-one) years of age, Referring physician's refusal to have his/her patient participate in the study. Patients with cardiac dysrhythmia (arrhythmia), including atrial fibrillation, and frequent premature atrial and/or ventricular contractions. Inability to obtain a Sotera cuff pressure and/or PPG signals

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measurement of PPG waveforms<br>Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours | Device: Measurement of PPG waveforms<br>* The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.<br>* Other names: ViSi Monitor;|
| Experimental: Measurement of Pulse Arrival Time (PAT)<br>Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours | Device: Measurement of Pulse Arrival Time (PAT)<br>* The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.<br>* Other names: ViSi Monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome. | The goal of this study is to collect pulse arrival time data as a means for the assessment of upper airway obstruction. | 4 - 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome. | The goal of this study is to collect PPG waveforms as a means for the assessment of upper airway obstruction. | 4 - 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea