Validation of Sleep Apnea Screening Device
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|ClinicalTrials.gov Identifier: NCT02814227|
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Zansors® sleep screening device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Wireless Sensor Patch for Reducing Barriers to In-home Sleep Apnea Screening|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Zansors® sleep screening device
Zansors device compared to overnight polysomnography
Device: Zansors® sleep screening device
Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
- Specificity [ Time Frame: 8 hours ]Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
- Sensitivity [ Time Frame: 8 hours ]Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
- Positive Predictive Value (PPV) [ Time Frame: 8 hours ]PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
- Negative Predictive Value (NPV) [ Time Frame: 8 hours ]NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814227
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||J. Todd Arnedt, PhD||University of Michigan|