Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
NCT ID: NCT06008678
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2023-08-22
2023-11-29
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
RXiBreeze PAP System, Model RXiBreeze 20A
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Subject weighs \>30 kg
4. Subject has been prescribed the use of an Auto CPAP system
5. Subject agrees to fulfill all study-required tests, sleep lab session attendance, and assessments
6. Subject agrees to use the RXiBreeze PAP System as prescribed
7. Subject is willing and able to provide informed consent
Exclusion Criteria
2. Subject's Central Apnea Index from the baseline PSG is \> 20% of AHI
3. Subject has been diagnosed with severe (stage 3) coronary artery disease
4. Subject has been diagnosed with bullous lung disease
5. subject has been diagnosed with hypotension
6. subject has been diagnosed with bypassed upper airway pneumothorax
7. Subject is pregnant, breastfeeding, or planning on becoming pregnant during trial participation
8. Subject, in the opinion of the investigator, is not suitable for trial participation
22 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Resvent Medical Technology Co., Ltd.
INDUSTRY
Resvent Holding USA LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Mehran Farid, MD
Role: PRINCIPAL_INVESTIGATOR
Peninsula Sleep Center
Locations
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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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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KF-0611-6-0599
Identifier Type: -
Identifier Source: org_study_id