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

NCT06008678 | Completed FDA Device

• 1 other identifier: KF-0611-6-0599
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 9

Brief 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:

• Epworth Sleepiness Score (ESS); and
• Functional Outcomes of Sleep Questionnaire (FOSQ) short form.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; sleep apnea; CPAP; PAP; APAP

Outcome Measures

Primary Outcomes (2)

• AHI Event Detection

  Apnea-Hypopnea Index (AHI) as measured by the test device (RXiBreeze PAP System) will be compared to the AHI as measured by polysomnography (PSG) to determine equivalence at night 1. Equivalence will be considered if the mean difference in detected AHI is greater than the lower equivalence limit (EL) of -5 and less than the upper equivalence limit (EU) of 5.

  Night 1

• Responder Rate

  RXiBreeze PAP System Night 1 responder rate as compared to a performance goal of 50. Responder rate is based on Sher's Criteria, which are defined as having both a ≥ 50% reduction in AHI and a final AHI of \< 20 events per hour.

  Night 1

Secondary Outcomes (11)

• Night 7 responder rate

  Night 7

• Night 1 responder rate by baseline disease severity

  Night 1

• Night 7 RXiBreeze PAP System compliance rate

  Night 7

• Nights 1 and 7 Oxygen Desaturation Index (ODI)

  Nights 1 and 7

• Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)

  Nights 1 and 7

Other Outcomes (1)

• Safety Endpoint: Device- and/or therapy-related adverse events (AEs)

  Night 1 through completion of Night 7

Study Arms (1)

Treatment

OTHER

RXiBreeze PAP System, Model RXiBreeze 20A

Device: RXiBreeze PAP System, Model RXiBreeze 20A

Interventions

RXiBreeze PAP System, Model RXiBreeze 20A DEVICE

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.

Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Resvent Holding USA LTD: lead
• Avania: collaborator
• Resvent Medical Technology Co., Ltd.: collaborator

Study Sites (9)

Peninsula Sleep Center

Burlingame, California, 94010, United States

Location

Exalt Clinical Research

Chula Vista, California, 91910, United States

Location

Bay Sleep Clinic

Mountain View, California, 94040, United States

Location

Innovative Sleep Centers, Inc.

Redding, California, 96003, United States

Location

TriValley Sleep Center

San Ramon, California, 94583, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30328, United States

Location

Somnos Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Intrepid Research

Cincinnati, Ohio, 45240, United States

Location

Innovative Sleep Centers, PLLC

Tumwater, Washington, 98510, United States

Location

Related Publications (4)

• Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.

  PMID: 28162150 BACKGROUND

• Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. doi: 10.1093/sleep/19.2.156.

  PMID: 8855039 BACKGROUND

• Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

  PMID: 31300334 BACKGROUND

• Kushida CA, Chediak A, Berry RB, Brown LK, Gozal D, Iber C, Parthasarathy S, Quan SF, Rowley JA; Positive Airway Pressure Titration Task Force; American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71.

  PMID: 18468315 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mehran Farid, MD

  Peninsula Sleep Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-arm trial

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 23, 2023
• Study Start: August 22, 2023
• Primary Completion: November 22, 2023
• Study Completion: November 29, 2023
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)