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

NCT06008678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Resvent Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Resvent Holding USA LTD

    lead INDUSTRY

Principal Investigators

  • Mehran Farid, MD · Peninsula Sleep Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2023-11-22
Completion
2023-11-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008678 on ClinicalTrials.gov