Skip to main content
OpenTrials
Completed

NCT Number: NCT05570747

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.

Completed

Looking for future studies?

Notify Me

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

Usability

Other

Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.

Primary outcomes

  1. Time to Complete Each Setup

    Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.

    The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask

  2. Number of Technical Issues That Occurred During the Trial

    Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.

    The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask)

  3. Number of Times Subjects Needed Additional Instructions

    Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.

    The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.

Sponsors and collaborators

Lead sponsor

Bleep, LLC

Industry

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.