Validation of Sleep Apnea Screening Device

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an estimated 18-40 million adults and 0.7-3% of all children in the US. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.

Detailed Description
-----------------
Obstructive Sleep Apnea (OSA) results in tiredness, depression and fatigue, and has several associated common comorbidities. It is believed that over 80% of OSA remains undiagnosed. Poorer and disadvantaged communities are at higher risk for sleep disorders, including OSA, even after accounting for other risk factors. The gold-standard method for diagnosing OSA is in-laboratory polysomnography; however, this procedure is generally available only to patients with health insurance due to its high cost. As a result, communities at particularly high risk for OSA are less likely to have this serious sleep disorder appropriately diagnosed and treated. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Zansors® has developed a bioengineered, semiconductor prototype that measures breathing and movement during sleep. It is a 1.5 x 2.5 x 0.2 inch wireless package using four key technologies: an adjustable microphone; a 3-axis accelerometer; embedded algorithms to measure sleep events; and acrylic adhesive. The product will be designed as an FDA-approved over-the-counter device that the patient can wear during sleep and wake up with a color score of red, yellow, or green depending on their sleep apnea status. The features of this product include that it is home-based; easy to use; non-invasive; wireless; disposable; low cost ($20-50); and presents easily understandable test results. However, such a device must first be validated against gold-standard polysomnography. The specific goal of this project is to compare the Zansors® micro sleep sensor screening device against gold-standard polysomnography to establish the device's preliminary validity to screen for OSA accurately.

Official Title
-----------------
Wireless Sensor Patch for Reducing Barriers to In-home Sleep Apnea Screening

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

Intervention / Treatment
-----------------
* Device: Zansors® sleep screening device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be over 18 and referred by medical staff for an overnight assessment for suspected sleep apnea Exclusion Criteria: Pregnancy Heart disease including congestive heart failure or a pacemaker Breathing disorder (emphysema or chronic obstructive breathing disorder) Neurological disorder such as Parkinson's Disease Restless leg syndrome or Periodic limb movement Allergies to metal Pre-existing skin conditions where sensor would be attached

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: Zansors® sleep screening device<br>Zansors device compared to overnight polysomnography | Device: Zansors® sleep screening device<br>* Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals | 8 hours | 
| Positive Predictive Value (PPV) | PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals | 8 hours | 
| Negative Predictive Value (NPV) | NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea screening device