Obstructive Sleep ApneaNCT05559047
Field Usability Study of Eclipse Mask
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?
- Eclipse mask
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Nov 2022to 25 Jan 2023
- 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: Adults over the age of 18 who are CPAP users and attend SCAT centers who volunteer to be in the study.
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
Official title: Field Usability Study of Eclipse CPAP Device
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
- Eclipse mask
- 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.
Eclipse maskDevice
Users will interact with the Eclipse CPAP machine and report on usability/likeability.
| Study group | Role | What they receive |
|---|---|---|
| In-House Usability Study Group | Seventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night.
Participants will follow instructions to set up and put on the Eclipse nasal mask.
They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly. Receives: Device: Eclipse mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Asked for Additional Information
The total count of participants who asked for additional information during the course of home use of the mask was recorded
Measured: Throughout the duration of the study (48 hours)
Mask Likeability
A 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score.
Measured: At 48 hours
Number of Participants Who Experienced Technical Issues
Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded
Measured: The duration of the trial (48 h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start10 Nov 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
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
- 70 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
- NCT05559047
- Sponsor's protocol ID
- BSL-SNAP-002
- 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 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
- Field Usability Study of Eclipse CPAP Device
- ClinicalTrials.gov ID
- NCT05559047
- Acronym / sponsor ID
- BSL-SNAP-002
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bleep, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 29 Sep 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
- 1
| Arm | Type | Receives |
|---|---|---|
| In-House Usability Study Group | – | Device: Eclipse maskSeventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. Participants will follow instructions to set up and put on the Eclipse nasal mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over the age of 18 who are CPAP users and attend SCAT centers who volunteer to be in the study.
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 |
|---|---|---|
| Eclipse maskUsers will interact with the Eclipse CPAP machine and report on usability/likeability. | Device | In-House Usability Study Group |
Primary outcome
Number of Participants Who Asked for Additional Information
Time frame: Throughout the duration of the study (48 hours)
The total count of participants who asked for additional information during the course of home use of the mask was recorded
Mask Likeability
Time frame: At 48 hours
A 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score.
Number of Participants Who Experienced Technical Issues
Time frame: The duration of the trial (48 h)
Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded
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 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?
Number of Participants Who Asked for Additional Information (time frame: Throughout the duration of the study (48 hours)). 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.