Clinical trial NCT02814227: Validation of Sleep Apnea Screening Device
Official title: Wireless Sensor Patch for Reducing Barriers to In-home Sleep Apnea Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea screening device
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Zansors
First posted: 2016-06-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

1. an adjustable microphone;
2. a 3-axis accelerometer;
3. embedded algorithms to measure sleep events; and
4. 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.

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

Primary outcomes:
measure: Specificity
timeFrame: 8 hours
Secondary outcomes:
measure: Sensitivity
timeFrame: 8 hours
measure: Positive Predictive Value (PPV)
timeFrame: 8 hours
measure: Negative Predictive Value (NPV)
timeFrame: 8 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: J. Todd Arnedt, PhD
role: PRINCIPAL_INVESTIGATOR
References: