Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
2 other identifiers
observational
35
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 Oct 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
October 7, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2022
CompletedResults Posted
Study results publicly available
November 10, 2025
CompletedNovember 10, 2025
October 1, 2025
23 days
September 26, 2022
March 12, 2025
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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)
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.
Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Study Arms (2)
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.
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.
Interventions
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
Eligibility Criteria
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.
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stuart Heatherington, Founder and Executive Chairman of Bleep
- 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
October 7, 2022
Study Start
October 19, 2022
Primary Completion
November 11, 2022
Study Completion
November 11, 2022
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 protected health information (PHI) will be shared. Aggregated participant demographic data will be shared.