CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Zansors® sleep screening devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02814227
NCT02814227N/ACompleted

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

University of Michigan·interventional·Posted Jun 27, 2016·Updated Jan 30, 2023

In Brief

A clinical study evaluating Zansors® sleep screening device for Obstructive Sleep Apnea. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsZansors

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 27, 2016
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.0 years ago

Interventions

Zansors® sleep screening devicedevice

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