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Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask

NCT05818540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2025-11-10

Study results available
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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.

Conditions

Interventions

DEVICE

Eclipse novel CPAP mask

Participants will wear the mask for 6 hours a night for 60 days.

DEVICE

ResMed P-10 mask

Participants will wear the mask for 6 hours a night for 60 days.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Bleep, LLC

    lead INDUSTRY

Principal Investigators

  • Stuart Heatherington · Bleep, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-12-29
Completion
2023-12-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818540 on ClinicalTrials.gov