Nebula Study - Screener Apps and HSAT vs. PSG Comparison
NCT ID: NCT04597749
Last Updated: 2021-02-04
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-10-27
2021-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
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.
PSG
In-lab sleep polysomnography test
Home Sleep Apnea Test with FDA cleared devices
In-lab HST test
Non-Contact Screening App
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
Home Sleep Apnea Test with FDA cleared devices
In-lab HST test
Non-Contact Screening App
Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.
Eligibility Criteria
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Inclusion Criteria
* Participant is willing to provide informed consent
* Participant is willing to participate in all study related procedures
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Locations
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Clayton Sleep Institute
Maplewood, Missouri, United States
Countries
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Other Identifiers
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SLP-20-06-01
Identifier Type: -
Identifier Source: org_study_id
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