Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device

Bleep, LLC

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Other: Usability

Study type

Observational

Funder types

Industry

NIH

Identifiers

NCT05570747

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

BSL-SNAP-001

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

35 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

35 participants in 2 patient groups

traditional CPAP Nuance mask users

Description:

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 tries will be randomized.

Treatment:

Other: Usability

DreamPort-Eclipse mask users

Description:

Treatment:

Other: Usability

Trial documents