Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT05570747
• Lead Sponsor: Bleep, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Study Start: 2022-10-19
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to complete each setup	1 day	Investigators will record the time it takes the participant to set up and try on each device.
Number of technical issues	1 day	Investigators will record the number of observed technical issues that occurred when the participant attempts to set up and try on the device.
Number of times participant needs assistance	1 day	Investigators will record the number of times each participant requires assistance or additional instructions setting up and trying on each device.

Trial Locations

Locations (3)

AeroFlow Sleep; 🇺🇸 Asheville, North Carolina, United States

Advanced Respiratory and Sleep Medicine; 🇺🇸 Huntersville, North Carolina, United States

Sleep Centers of Middle Tennessee; 🇺🇸 Murfreesboro, Tennessee, United States