Sleep Apnea, ObstructiveNCT04597749
Nebula Study - Screener Apps and HSAT vs. PSG Comparison
A study testing PSG, Home Sleep Apnea Test with FDA cleared devices and Non-Contact Screening App in people with Sleep Apnea, Obstructive, run by ResMed at 1 site in United States.
Trial summary
This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- PSG, Home Sleep Apnea Test with FDA cleared devices and Non-Contact Screening App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Nebula Study: Comparison of Sleep Screener Apps and Home Sleep Apnea Tests to Polysomnography
This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- PSG, Home Sleep Apnea Test with FDA cleared devices, Non-Contact Screening App
- Keywords
- OSA, Sleep Apnea, OSA Screeners, Home Sleep Apnea Test
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGDiagnostic test
In-lab sleep polysomnography test
Home Sleep Apnea Test with FDA cleared devicesDiagnostic test
In-lab HST test
Non-Contact Screening AppOther
Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent PSG, HSAT, and Screener App Test | Experimental | Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone. Receives: Diagnostic Test: PSG; Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices; Other: Non-Contact Screening App |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.
The PSG clinical decision for treatment is defined as AHI≥15. Screener apps and HSATs provide AHI values that will be used for comparison.
Measured: Day 1
Secondary outcomes (1)
OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start27 Oct 2020
- Primary completion31 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597749
- Sponsor's protocol ID
- SLP-20-06-01
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebula Study: Comparison of Sleep Screener Apps and Home Sleep Apnea Tests to Polysomnography
- ClinicalTrials.gov ID
- NCT04597749
- Acronym / sponsor ID
- SLP-20-06-01
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- OSA, Sleep Apnea, OSA Screeners, Home Sleep Apnea Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent PSG, HSAT, and Screener App Test | Experimental | Diagnostic Test: PSG, Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices, Other: Non-Contact Screening AppParticipants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSGIn-lab sleep polysomnography test | Diagnostic test | Concurrent PSG, HSAT, and Screener App Test |
| Home Sleep Apnea Test with FDA cleared devicesIn-lab HST test | Diagnostic test | Concurrent PSG, HSAT, and Screener App Test |
| Non-Contact Screening AppNon-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea. | Other | Concurrent PSG, HSAT, and Screener App Test |
Primary outcome
AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.
Time frame: Day 1
The PSG clinical decision for treatment is defined as AHI≥15. Screener apps and HSATs provide AHI values that will be used for comparison.
1 secondary outcome
OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSG, Home Sleep Apnea Test with FDA cleared devices and Non-Contact Screening App in people with Sleep Apnea, Obstructive, run by ResMed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.