NCT05559047

Field Usability Study of Eclipse Mask

Completed Results posted Last updated 10 November 2025

What this trial tests

trial testing Eclipse mask in Obstructive Sleep Apnea in 70 participants. Completed in 25 January 2023.

Timeline

10 November 2022

Primary endpoint
25 January 2023

25 January 2023

Quick facts

Lead sponsor	Bleep, LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	70
Start date	10 November 2022
Primary completion	25 January 2023
Estimated completion	25 January 2023
Sites	3 locations across United States

Drugs / interventions tested

• Eclipse mask

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Bleep, LLC

Who can join

18 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Asked for Additional Information Primary · Throughout the duration of the study (48 hours)

The total count of participants who asked for additional information during the course of home use of the mask was recorded

Group	Value	95% CI
Eclipse Novel CPAP Mask	6

Mask Likeability Primary · At 48 hours

A 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score.

Group	Value	95% CI
Eclipse Novel CPAP Mask	4.1	± 0.4

Number of Participants Who Experienced Technical Issues Primary · The duration of the trial (48 h)

Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded

Group	Value	95% CI
Eclipse Novel CPAP Mask	7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.