Field Usability Study of Eclipse Mask

Field Usability Study of Eclipse CPAP Device

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Eclipse mask

• Study Type: Observational
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • AeroFlow Sleep
    • Huntersville, North Carolina, United States, 98078
      • Advanced Respiratory and Sleep Medicine
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • Sleep Centers of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults over the age of 18 who are CPAP users and attend SCAT centers who volunteer to be in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

In-House Usability Study Group; 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.

Device: Eclipse mask; Users will interact with the Eclipse CPAP machine and report on usability/likeability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Asked for Additional Information	The total count of participants who asked for additional information during the course of home use of the mask was recorded	Throughout the duration of the study (48 hours)
Mask Likeability	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.	At 48 hours
Number of Participants Who Experienced Technical Issues	Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded	The duration of the trial (48 h)

Collaborators and Investigators

• Sponsor: Bleep, LLC
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Stuart Heatherington, Bleep, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: BSL-SNAP-002; 1R44HL158286-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected through surveys will be available upon request to the principal investigator. Data requested will be de-identified. Only de-identified data will be made available. Only survey responses and the investigators' observational notes, also deidentified, will be shared. No PHI will be shared. Aggregated participant demographic data will be shared.
• IPD Sharing Time Frame: Data will become available 4 years after the study completion.
• IPD Sharing Access Criteria: Requests will be made in writing, to the PI, at stuart@bleepsleep.com. Requests should include the reason for the request, how the data is intended to be used, and additional information may be requested. Data will be shared with credentialed, licensed, or otherwise verifiable researchers/investigators for research purposes only.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No