Clinical trial NCT06008678: Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Official title: A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
sleep apnea
CPAP
PAP
APAP
Lead sponsor: Resvent Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Avania
name: Resvent Medical Technology Co., Ltd.
First posted: 2023-08-23
Enrollment: 146
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm trial
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 22 years old
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:

1. Subject has been diagnosed with a sleep disorder other than OSA
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

Primary outcomes:
measure: AHI Event Detection
timeFrame: Night 1
measure: Responder Rate
timeFrame: Night 1
Secondary outcomes:
measure: Night 7 responder rate
timeFrame: Night 7
measure: Night 1 responder rate by baseline disease severity
timeFrame: Night 1
measure: Night 7 RXiBreeze PAP System compliance rate
timeFrame: Night 7
measure: Nights 1 and 7 Oxygen Desaturation Index (ODI)
timeFrame: Nights 1 and 7
measure: Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)
timeFrame: Nights 1 and 7
measure: Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7
timeFrame: Nights 1 and 7
measure: Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7
timeFrame: Nights 1 and 7
measure: Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7
timeFrame: Nights 1 and 7
measure: Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7
timeFrame: Nights 1 and 7
measure: Epworth Sleepiness Scale (ESS) on Night 1 and Night 7
timeFrame: Nights 1 and 7
measure: Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7
timeFrame: Nights 1 and 7
Other outcomes:
measure: Safety Endpoint: Device- and/or therapy-related adverse events (AEs)
timeFrame: Night 1 through completion of Night 7
Locations:
city: Burlingame
country: United States
facility: Peninsula Sleep Center
state: California
city: Chula Vista
country: United States
facility: Exalt Clinical Research
state: California
city: Mountain View
country: United States
facility: Bay Sleep Clinic
state: California
city: Redding
country: United States
facility: Innovative Sleep Centers, Inc.
state: California
city: San Ramon
country: United States
facility: TriValley Sleep Center
state: California
city: Atlanta
country: United States
facility: NeuroTrials Research
state: Georgia
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Tumwater
country: United States
facility: Innovative Sleep Centers, PLLC
state: Washington
Study officials:
affiliation: Peninsula Sleep Center
name: Mehran Farid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.