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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Eclipse novel CPAP mask; Device: ResMed P-10 mask

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • Sleep Centers of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device

Exclusion Criteria:

• Any medical or behavioral conditions that would compromise subject safety
• Under the age of 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eclipse novel mask; Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.	Device: Eclipse novel CPAP mask; Participants will wear the mask for 6 hours a night for 60 days.
Active Comparator: Traditional CPAP mask; Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.	Device: ResMed P-10 mask; Participants will wear the mask for 6 hours a night for 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction With the Mask Choice	A 16-item patient survey was administered to the participants in each arm at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). This reflects the average of all the answered items. For example, question number one had an average score of 4.48 for the eclipse mask arm and 4.12 for the standard mask arm, question number 2 had an average score of 4.40 for the eclipse mask arm and 4.42 for the standard mask arm, etc. Since all questions reflect participant satisfaction, they were averaged to provide an overall score.	60 days
Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability)	We estimated the mask tolerability as follows (as a percentage): 100*(participants who completed the trial) / [(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)].	60 days

Collaborators and Investigators

• Sponsor: Bleep, LLC
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Stuart Heatherington, Bleep, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: BSL-SNAP-003; 1R44HL158286-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available 4 years after the study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No