Status:
COMPLETED
Oran Park Mask External Clinical Study (3) Marketing Claims Study
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this stu...
Eligibility Criteria
Inclusion
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 12 months
- Participants who have met CMS compliance for CPAP therapy over the last 3 months
- Participants who have been using a ResMed cloud connected AirSense10 or AirSense 11 device compatible with AirView, for more than 12 months
- Participants currently using a suitable mask system\*
- Participants who can trial the masks for up to 7 nights each
- Note\*: Suitable mask system includes any tube down full face mask (e.g. AirFit F30, AirFit F20, AirTouch F20, AirFit F10, Quattro Air, Quattro Fx, Mirage Quattro, Simplus, Amara, Amara Gel, Comfort gel Full Face Mask, Evora Full)
Exclusion
- Participants using Bi-level flow generators
- Participants who are or may be pregnant
- Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
- Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
- Participants who use a rental unit for AirSense 10 or AirSense 11 device
- Participants believed to be unsuitable for inclusion by the researcher
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06079866
Start Date
October 4 2023
End Date
November 20 2023
Last Update
February 29 2024
Active Locations (2)
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1
Sleep Data
San Diego, California, United States, 92123
2
Clayton Sleep Institute
St Louis, Missouri, United States, 63123