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NCT05559047 | Completed | Obstructive Sleep Apnea

Field Usability Study of Eclipse Mask
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.

Condition or disease

Obstructive Sleep Apnea

Intervention/treatment

Eclipse novel CPAP mask

Philips Respironics Nuance

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 70 participants
Masking : None (Open Label)
Masking Description : Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.
Primary Purpose : Device Feasibility
Official Title : Field Usability Study of Eclipse CPAP Device
Actual Study Start Date : November 10, 2022
Estimated Primary Completion Date : January 25, 2023
Estimated Study Completion Date : January 25, 2023
Arm Intervention/treatment

Experimental: In-House Usability Study Group

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.

Device: Eclipse novel CPAP mask

Device: Phillips Respironics Nuance
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.
Field Usability Study of Eclipse Mask

Location Details

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Field Usability Study of Eclipse Mask

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

AeroFlow Sleep

Asheville, North Carolina, United States, 28803

Not yet recruiting

United States, North Carolina

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, United States, 98078

Not yet recruiting

United States, Tennessee

Sleep Centers of Middle Tennessee

Murfreesboro, Tennessee, United States, 37129