Validation of Sleep Apnea Screening Device

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Zansors® sleep screening device

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Zansors

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 25, 2015
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: obstructive sleep apnea screening device
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: R41MD008845-01 (U.S. NIH Grant/Contract)