Validation of Sleep Apnea Screening Device

NCT02814227 | Completed Results

• 1 other identifier: R41MD008845-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea screening device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity

  8 hours

• Positive Predictive Value (PPV)

  8 hours

• Negative Predictive Value (NPV)

  8 hours

Study Arms (1)

Zansors® sleep screening device

EXPERIMENTAL

Zansors device compared to overnight polysomnography

Device: Zansors® sleep screening device

Interventions

Zansors® sleep screening device DEVICE

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

Zansors® sleep screening device

Eligibility Criteria

• Age: 18 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 overnight assessment for suspected sleep apnea

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, 48109, 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

Results Point of Contact

• Title: J. Todd Arnedt, PhD
• Organization: University of Michigan

tarnedt@med.umich.edu

734-615-8666

Study Officials

• J. Todd Arnedt, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2015
• First Posted: June 27, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 30, 2023
• Results First Posted: July 26, 2017

Record last verified: 2023-01

Locations

US (1)