Field Usability Study of Eclipse Mask
2 other identifiers
observational
70
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2022
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedStudy Start
First participant enrolled
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2023
CompletedResults Posted
Study results publicly available
November 10, 2025
CompletedNovember 10, 2025
October 1, 2025
3 months
September 26, 2022
March 12, 2025
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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.
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
The duration of the trial (48 h)
Study Arms (1)
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.
Interventions
Users will interact with the Eclipse CPAP machine and report on usability/likeability.
Eligibility Criteria
Adults over the age of 18 who are CPAP users and attend SCAT centers who volunteer to be in the study.
You may qualify if:
- Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bleep, LLClead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (3)
AeroFlow Sleep
Asheville, North Carolina, 28803, United States
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 98078, United States
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, 37129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stuart Heatherington
- Organization
- Bleep, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Heatherington
Bleep, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2022
First Posted
September 29, 2022
Study Start
November 10, 2022
Primary Completion
January 25, 2023
Study Completion
January 25, 2023
Last Updated
November 10, 2025
Results First Posted
November 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will become available 4 years after the study completion.
- Access Criteria
- Requests will be made in writing, to the PI, at stuart@bleepsleep.com. Requests should include the reason for the request, how the data is intended to be used, and additional information may be requested. Data will be shared with credentialed, licensed, or otherwise verifiable researchers/investigators for research purposes only.
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.