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

Bleep, LLC

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Eclipse novel CPAP mask; Device: ResMed P-10 mask

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05818540

1R44HL158286-01A1 (U.S. NIH Grant/Contract)

BSL-SNAP-003

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

173 participants in 2 patient groups

Eclipse novel mask

Experimental group

Description:

Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.

Treatment:

Device: Eclipse novel CPAP mask

Traditional CPAP mask

Active Comparator group

Description:

Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.

Treatment:

Device: ResMed P-10 mask