Field Usability Study of Eclipse Mask

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Eclipse novel CPAP mask; Device: Phillips Respironics Nuance

• Registration Number: NCT05559047
• 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: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2022-11-10
• Status Verified: 2023-01
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Arm && Interventions

Group	Intervention	Description
In-House Usability Study Group	Eclipse novel CPAP 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 tries will be randomized.
In-House Usability Study Group	Phillips Respironics Nuance	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.

Primary Outcome Measures

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

Trial Locations

Locations (3)

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

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

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