NCT06008678

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

A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Resvent Holding USA LTD · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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 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.

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. 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	RXiBreeze PAP System, Model RXiBreeze 20A	The RXiBreeze PAP System is a prescription-only positive airway pressure (PAP) ventilator used to treat obstructive sleep apnea (OSA). It is a microprocessor-controlled device that provides mechanical ventilation to a subject.

Timeline

• Start date: 2023-08-22
• Primary completion: 2023-11-22
• Completion: 2023-11-29
• First posted: 2023-08-23
• Last updated: 2024-12-02

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study