Nebula Study - Screener Apps and HSAT vs. PSG Comparison

ResMed

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Other: Non-Contact Screening App; Diagnostic Test: PSG; Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT04597749

SLP-20-06-01

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Concurrent PSG, HSAT, and Screener App Test

Experimental group

Description:

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

Treatment:

Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices

Other: Non-Contact Screening App

Diagnostic Test: PSG