Status:
COMPLETED
Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Lead Sponsor:
Resvent Holding USA LTD
Collaborating Sponsors:
Avania
Resvent Medical Technology Co., Ltd.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA). The main questions t...
Detailed Description
This is a prospective, multicenter, single-arm trial designed to evaluate the safety and effectiveness of the RXiBreeze PAP System to treat obstructive sleep apnea and detect breathing events. Eligibl...
Eligibility Criteria
Inclusion
- Subject is ≥ 22 years old
- Subject has been diagnosed with OSA (as scored per AASM scoring guidelines) and has an AHI ≥ 10, based on the results of a sleep study conducted at an accredited sleep lab, within 30 days prior to enrollment
- Subject weighs \>30 kg
- Subject has been prescribed the use of an Auto CPAP system
- Subject agrees to fulfill all study-required tests, sleep lab session attendance, and assessments
- Subject agrees to use the RXiBreeze PAP System as prescribed
- Subject is willing and able to provide informed consent
Exclusion
- Subject has been diagnosed with a sleep disorder other than OSA
- Subject's Central Apnea Index from the baseline PSG is \> 20% of AHI
- Subject has been diagnosed with severe (stage 3) coronary artery disease
- Subject has been diagnosed with bullous lung disease
- subject has been diagnosed with hypotension
- subject has been diagnosed with bypassed upper airway pneumothorax
- Subject is pregnant, breastfeeding, or planning on becoming pregnant during trial participation
- Subject, in the opinion of the investigator, is not suitable for trial participation
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06008678
Start Date
August 22 2023
End Date
November 29 2023
Last Update
December 2 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Peninsula Sleep Center
Burlingame, California, United States, 94010
2
Exalt Clinical Research
Chula Vista, California, United States, 91910
3
Bay Sleep Clinic
Mountain View, California, United States, 94040
4
Innovative Sleep Centers, Inc.
Redding, California, United States, 96003