Nebula Study - Screener Apps and HSAT vs. PSG Comparison

NCT ID: NCT04597749

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2021-01-20

Brief Summary

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This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Concurrent PSG, HSAT, and Screener App Test

Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.

Group Type EXPERIMENTAL

PSG

Intervention Type DIAGNOSTIC_TEST

In-lab sleep polysomnography test

Home Sleep Apnea Test with FDA cleared devices

Intervention Type DIAGNOSTIC_TEST

In-lab HST test

Non-Contact Screening App

Intervention Type OTHER

Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.

Interventions

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PSG

In-lab sleep polysomnography test

Intervention Type DIAGNOSTIC_TEST

Home Sleep Apnea Test with FDA cleared devices

In-lab HST test

Intervention Type DIAGNOSTIC_TEST

Non-Contact Screening App

Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant is 18 years of age or older
* Participant is willing to provide informed consent
* Participant is willing to participate in all study related procedures

Exclusion Criteria

* Unable to cease PAP therapy during PSG (if currently using)
* Requires use of oxygen therapy during sleep
* Diagnosis of untreated clinically relevant sleep disorder (other than SDB)
* Pregnant
* Participant is unsuitable to participate in the study in the opinion of the investigator
* Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clayton Sleep Institute

Maplewood, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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SLP-20-06-01

Identifier Type: -

Identifier Source: org_study_id

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