PMP-300E (Smart Watch): Portable Monitoring Device Study

Study Overview
=================
Brief Summary
-----------------
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Detailed Description
-----------------
The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process compared data collected by PMP-300E with data collected from in-lab polysomnography.

Official Title
-----------------
PMP-300E: Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: PMP-300E
* Device: In-lab PSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Inclusion Criteria: Age 18 and over. Require a sleep diagnostic study by physician's order. Able and willing to provide written informed consent. Able to speak and read English. Exclusion Criteria:Exclusion Criteria: Participation in another interventional research study within the last 30 days. Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure. Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes). Consumption of ethanol more than 4 nights per week. (CAGE criteria) Use of recreational drug within the past 12 months. Women who are pregnant or currently lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMP-300E, In-Lab PSG<br>PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study) | Device: PMP-300E<br>* Data collected from Level 3 device<br>* Other names: Sleep Diagnostic Device;Device: In-lab PSG<br>* Data collected from Type I In-Lab Polysomnography<br>* Other names: Sleep Study;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI | Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals. | One night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Index | Number of events/hour of sleep | One night | 
| Hypopnea Index | Number of events/hour of sleep. Hypopneas scored without EEG arousals. | One night | 
| Oxygen Saturation | Mean oxygen saturation | One night |