Validation of Sleep Apnea Screening Device Phase II

NCT03025464 | Terminated Phase 2

• 1 other identifier: R42MD008845-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity

  8 hours

• Positive Predictive Value (PPV)

  8 hours

• Negative Predictive Value (NPV)

  8 hours

Interventions

Obstructive Sleep Apnea Screening Device DEVICE

Assessment of ability of device to detect apneas and hypopneas to screen for OSA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Zansors: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: November 14, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)