Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Key facts
- Who runs it
- Resvent Holding USA LTD
- Where
- Atlanta, Burlingame, Chula Vista, Cincinnati, Lincoln, Mountain View, Redding, San Ramon, and Tumwater, United StatesSee the 9 sites
- Trial code
- Status
- Completed
- People taking part
- 146 people enrolled
- Started
- 22 Aug 2023
- Ended
- 29 Nov 2023
- Type of study
- Interventional
- Treatments tested
- RXiBreeze PAP System, Model RXiBreeze 20A
- Record updated
- 2 December 2024
Who can take part
- Age
- 22 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Subject has been diagnosed with a sleep disorder other than OSA
- Subject has been diagnosed with severe (stage 3) coronary artery disease
- Subject has been diagnosed with bullous lung disease
- Subject's Central Apnea Index from the baseline PSG is > 20% of AHI
- 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
Where in United States
- NeuroTrials ResearchAtlanta, United States
- Peninsula Sleep CenterBurlingame, United States
- Exalt Clinical ResearchChula Vista, United States
- Intrepid ResearchCincinnati, United States
- Somnos Clinical ResearchLincoln, United States
- Bay Sleep ClinicMountain View, United States
- Innovative Sleep Centers, Inc.Redding, United States
- TriValley Sleep CenterSan Ramon, United States
- Innovative Sleep Centers, PLLCTumwater, United States
About the trial
What the trial wants to find out
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:
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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.
The group in the trial
- TreatmentOther group
RXiBreeze PAP System, Model RXiBreeze 20A
Treatment: RXiBreeze PAP System, Model RXiBreeze 20A
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
- Record updated
- 2 December 2024