Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT06008678

Run by

Resvent Holding USA LTD

People needed

146

Starts

2023-08-22

Expected to finish

2023-11-29

Last updated by the study team

2024-12-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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