Obstructive Sleep ApneaNCT05570747
Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
An observational study of Obstructive Sleep Apnea, run by Bleep, LLC at 3 sites in United States.
Trial summary
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Usability
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Oct 2022to 11 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients were regular clients at the SCMT offices in Murfreesboro and Clarksville. SCMT patients who were already adherent CPAP users were asked if they wanted to participate in research.
Who may be able to join
- Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.
Who cannot join
- Diagnosis of any medical or behavioral conditions that would compromise subject safety.
- Under the age of 18: target for this current version of the platform is the adult population.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AeroFlow Sleep
Asheville, North Carolina, 28803
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 98078
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, 37129
About this study
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Usability
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UsabilityOther
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
| Study group | Role | What they receive |
|---|---|---|
| traditional CPAP Nuance mask users | Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized. Receives: Other: Usability | |
| DreamPort-Eclipse mask users | Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized. Receives: Other: Usability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Each Setup
The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask
Measured: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Number of Technical Issues That Occurred During the Trial
The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask)
Measured: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Number of Times Subjects Needed Additional Instructions
The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.
Measured: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start19 Oct 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bleep, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stuart Heatherington, Principal investigator, Bleep, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570747
- Sponsor's protocol ID
- BSL-SNAP-001
- Other IDs
- 1R44HL158286-01A1
- Status last verified
- Oct 2025
- First submitted
- 26 Sep 2022
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data collected through surveys will be available upon request to the principal investigator. Data requested will be de-identified. Only de-identified data will be made available. Only survey responses and the investigators' observational notes, also deidentified, will be shared. No protected health information (PHI) will be shared. Aggregated participant demographic data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
- ClinicalTrials.gov ID
- NCT05570747
- Acronym / sponsor ID
- BSL-SNAP-001
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bleep, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional CPAP Nuance mask users | – | Other: UsabilityHuman subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized. |
| DreamPort-Eclipse mask users | – | Other: UsabilityHuman subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were regular clients at the SCMT offices in Murfreesboro and Clarksville. SCMT patients who were already adherent CPAP users were asked if they wanted to participate in research.
Key inclusion criteria (1 listed)
- Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.
Key exclusion criteria (2 listed)
- Diagnosis of any medical or behavioral conditions that would compromise subject safety.
- Under the age of 18: target for this current version of the platform is the adult population.
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 |
|---|---|---|
| UsabilityPatients will be observed and asked a serious of questions while they put the mask on and after they remove it. | Other | DreamPort-Eclipse mask users, traditional CPAP Nuance mask users |
Primary outcome
Time to Complete Each Setup
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask
Number of Technical Issues That Occurred During the Trial
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask)
Number of Times Subjects Needed Additional Instructions
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data collected through surveys will be available upon request to the principal investigator. Data requested will be de-identified. Only de-identified data will be made available. Only survey responses and the investigators' observational notes, also deidentified, will be shared. No protected health information (PHI) will be shared. Aggregated participant demographic data will be shared.
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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.
Stuart Heatherington principal investigator
Bleep, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Bleep, LLC at 3 sites 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 1 inclusion and 2 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Complete Each Setup (time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.). The study lists 3 primary outcomes in all. 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 10 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.