Field Usability Study of Eclipse Mask

Bleep, LLC

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Eclipse mask

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT05559047

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

BSL-SNAP-002

Details and patient eligibility

About

The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.

Enrollment: 70 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

• Diagnosis of any medical or behavioral conditions that would compromise subject safety.
• Under the age of 18: target for this current version of the platform is the adult population.

Trial design

70 participants in 1 patient group

In-House Usability Study Group

Description:

Seventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. Participants will follow instructions to set up and put on the Eclipse nasal mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.

Treatment:

Device: Eclipse mask