CompletedNot Applicable

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

United States173 participantsStarted 2023-04-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Apnea-Hypopnea Index (AHI)

Timeframe: 60 days

Leak

Timeframe: 60 days

CPAP Device Pressure (P95)

Timeframe: 60 days

Trial details

NCT IDNCT05818540

SponsorBleep, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-29

Results submitted2025-03-13

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials