Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask
2 other identifiers
interventional
173
1 country
1
Brief Summary
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
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
April 4, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedResults Posted
Study results publicly available
November 10, 2025
CompletedNovember 10, 2025
October 1, 2025
9 months
April 4, 2023
March 13, 2025
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Apnea-Hypopnea Index (AHI)
AHI recorded from the software built-in algorithm. The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.
60 days
Leak
Data were captured from the device in L/min at 60 days. Leak is how much flow in L exits the mask while the patient wears it each min. It is recorded through proprietary algorithm undisclosed to the public by the device
60 days
CPAP Device Pressure (P95)
Therapeutic positive pressure (in cmH2O) that the device administer for 95% of the night. It is recorded through proprietary algorithm undisclosed to the public by the device.
60 days
Secondary Outcomes (2)
Participant Satisfaction With the Mask Choice
60 days
Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability)
60 days
Study Arms (2)
Eclipse novel mask
EXPERIMENTALHuman subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
Traditional CPAP mask
ACTIVE COMPARATORHuman subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
Interventions
Participants will wear the mask for 6 hours a night for 60 days.
Participants will wear the mask for 6 hours a night for 60 days.
Eligibility Criteria
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:
- Any medical or behavioral conditions that would compromise subject safety
- Under the age of 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bleep, LLClead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, 37129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stuart Heathington
- 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
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
April 19, 2023
Study Start
April 17, 2023
Primary Completion
December 29, 2023
Study Completion
December 29, 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.