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A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
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 the study aims to answer are: 1. Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG? 2. What is the responder rate using the RXiBreeze PAP System? Participants will use the APAP function of the RXiBreeze PAP System while undergoing polysomnography (PSG) for two separate nights in a sleep center. During each visit, participants will also complete two patient reported outcome questionnaires: * Epworth Sleepiness Score (ESS); and * Functional Outcomes of Sleep Questionnaire (FOSQ) short form.
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. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria will be consented for study participation. The study will enroll up to 68 subjects. Baseline PSG will be obtained. Subjects will return to the sleep lab and use the RXiBreeze PAP System while undergoing a PSG. The data from both the RXiBreeze PAP System and PSG from both nights will be sent to an independent core lab for blinded AHI scoring. Data will be evaluated in accordance with current American Academy of Sleep Medicine (AASM) scoring guidelines. In addition to the device/PSG data scoring, subjects will complete the Epworth Sleepiness Score (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) short form (10 questions) and be assessed for device- and/or therapy-related adverse events (AEs) at the end of each visit.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
Peninsula Sleep Center
Burlingame, California, United States
Exalt Clinical Research
Chula Vista, California, United States
Bay Sleep Clinic
Mountain View, California, United States
Innovative Sleep Centers, Inc.
Redding, California, United States
TriValley Sleep Center
San Ramon, California, United States
NeuroTrials Research
Atlanta, Georgia, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Intrepid Research
Cincinnati, Ohio, United States
Innovative Sleep Centers, PLLC
Tumwater, Washington, United States
Start Date
August 22, 2023
Primary Completion Date
November 22, 2023
Completion Date
November 29, 2023
Last Updated
December 2, 2024
146
ACTUAL participants
RXiBreeze PAP System, Model RXiBreeze 20A
DEVICE
Lead Sponsor
Resvent Holding USA LTD
Collaborators
NCT06430957
NCT07292922
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07225686