Validation of Sleep Apnea Screening Device Phase II

Wireless Sensor Patch for Educing Barriers to In-home Sleep Apnea Screening, Phase II

Obstructive sleep apnea (OSA) is the most common type of sleep apnea. 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. Over the past year, this investigative team has engineered a small screening device (Zerify®) for OSA and obtained preliminary evidence of its efficacy in a clinical population under a NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data, transfer these data to a computer, and detect non-clinical simulated apnea events with a specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary psychometric performance data of the screening device in a clinical sample of 52 patients (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard polysomnography. Phase II proposal aims to optimize the engineered hardware and associated OSA algorithms, create a patient companion app and wireless healthcare provider dashboard, and compare the efficacy of this screening device to the most commonly utilized sleep apnea screener, the home sleep apnea test (HSAT).

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Obstructive Sleep Apnea Screening Device

Detailed Description

An alternative to polysomnography (PSG), which is done overnight in a lab, is home sleep apnea testing (HSAT). Also known as out-of-center testing, HSAT has emerged as a more convenient and increasingly widely used method to screen for sleep apnea. HSAT records fewer signals for assessment, is less cumbersome than traditional PSG, and allows patients to spend the night at home, eliminating the need for technical staff to be present during testing. HSAT is considerably less expensive than PSG to perform. Despite its advantages, there are concerns about false-negatives and underestimation of disease severity with HSAT. There is clearly a need to improve the accuracy of less costly screening tools for OSA. Zansors® wireless microsensor is a novel device to screen for sleep apnea, which measures breathing patterns and movement, and which will collect data and communicate with a smartphone via Bluetooth. In this study, investigators are comparing the Zansors microsensor to HSAT and PSG to assess its accuracy. Patients will be asked to wear the device during the clinical HSAT ordered by their doctor, and again at an in-laboratory sleep study. When patients are being trained to use the HSAT equipment, research staff will also show them how to put the Zansors® device on. They will then wear it at home on the night of their HSAT. At a later date, when they come for the in-laboratory sleep study, the device will again be worn overnight while they are being assessed by the full PSG equipment. Together in this study, all these device recordings will help to detect any sleep apnea and researchers will compare the results of the Zansors ® microsensor with HSAT and PSG equipment. If the Zansors ® device is confirmed to detect sleep hypopneas and apneas accurately, it can be used easily and inexpensively by people at home to screen for obstructive sleep apnea.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (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 assessment for suspected sleep apnea using either a home sleep apnea testing device or in-lab PSG equipment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	Specificity of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to 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 hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.	8 hours
Positive Predictive Value (PPV)	PPV of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.	8 hours
Negative Predictive Value (NPV)	NPV of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to 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 (Actual): November 14, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• 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: R42MD008845-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No