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OpenTrials
Completed

NCT Number: NCT05559047

Field Usability Study of Eclipse Mask

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AeroFlow Sleep, Asheville, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eclipse mask

Device

Users will interact with the Eclipse CPAP machine and report on usability/likeability.

Primary outcomes

  1. Number of Participants Who Asked for Additional Information

    Time frame: 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

  2. Mask Likeability

    Time frame: 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.

  3. Number of Participants Who Experienced Technical Issues

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bleep, LLC

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Field Usability Study of Eclipse CPAP Device

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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