Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (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: Other: Usability

• Study Type: Observational
• Enrollment (Actual): 35
• 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: Probability Sample

Study Population

Patients were regular clients at the SCMT offices in Murfreesboro and Clarksville. SCMT patients who were already adherent CPAP users were asked if they wanted to participate in research.

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

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
traditional CPAP Nuance mask users; 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.	Other: Usability; Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
DreamPort-Eclipse mask users; 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.	Other: Usability; Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Each Setup	The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask	Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Number of Technical Issues That Occurred During the Trial	The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask)	Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Number of Times Subjects Needed Additional Instructions	The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.	Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.

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): October 19, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 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; Investigative Techniques; Technology, Industry, and Agriculture; Equipment Design; Universal Design; Engineering; User-Centered Design
• Other Study ID Numbers: BSL-SNAP-001; 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 protected health information (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