Validation of Sleep Apnea Screening Device

NCT ID: NCT02814227

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Zansors® sleep screening device

Zansors device compared to overnight polysomnography

Group Type: EXPERIMENTAL

Zansors® sleep screening device

Intervention Type: DEVICE

Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography

Interventions

Zansors® sleep screening device

Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zansors

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

J. Todd Arnedt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Todd Arnedt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

R41MD008845-01

Identifier Type: NIH

Identifier Source: org_study_id

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