Back to resultsStudy of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RXiBreeze PAP System, Model RXiBreeze 20A
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, sleep apnea, CPAP, PAP, APAP
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Peninsula Sleep Center
- NeuroTrials Research
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
RXiBreeze PAP System, Model RXiBreeze 20A
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Night 7 responder rate
. 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 responder rate by baseline disease severity
Responder rate presented by disease severity in accordance with AASM scoring guidelines. 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 7 RXiBreeze PAP System compliance rate
Compliance rate is measure of subject use of the RXiBreeze PAP System presented by descriptive statistics.
Nights 1 and 7 Oxygen Desaturation Index (ODI)
ODI is average number of desaturation episodes per hour. ODI will be presented by descriptive statistics.
Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)
Oxygen saturation is a measure of the amount of oxygen that is circulating in the blood. T90 oxygen saturation will be presented by descriptive statistics.
Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7
Obstructive Apnea Index (OAI) as measured by the test device (RXiBreeze PAP System) will be compared to the OAI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7
Event Detection Validation: Hypopnea Index (HI) as measured by the test device (RXiBreeze PAP System) will be compared to the HI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7
Event Detection Validation: Central Apnea Index (CAI) as measured by the test device (RXiBreeze PAP System) will be compared to the CAI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7
Event Detection Validation: Apnea Index (AI) as measured by the test device (RXiBreeze PAP System) will be compared to the AI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Epworth Sleepiness Scale (ESS) on Night 1 and Night 7
Epworth Sleepiness Scale (ESS) is a validated patient reported outcome (PRO) questionnaire consisting of 8 questions related to daytime sleepiness. The ESS results in a score from 0 to 24 (0 - 10 reflect normal levels of daytime sleepiness, scores over 10 reflect excessive daytime sleepiness (EDS), scores of 16 or more suggest a high level of EDS. The ESS will be self-administered by subjects at the Night 1 and Night 7 visits. Results will be presented by frequency and percentages.
Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7
Functional Outcomes of Sleep Questionnaire (FOSQ) short form is a validated patient reported outcome (PRO) questionnaire consisting of 10 questions related to the impact of sleepiness on the ability to conduct daily activities. The FOSQ-10 questions are rates on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty). A total score and 5 subscale scores (vigilance, general productivity, social outcome, intimacy, and activity level) are calculated. Subscale scores range from 1 (maximum difficulty) to 4 (no difficulty).
Full Information
NCT ID
NCT06008678
First Posted
August 11, 2023
Last Updated
August 18, 2023
Sponsor
Resvent Holding USA LTD
Collaborators
Avania, Resvent Medical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06008678
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 14, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Resvent Holding USA LTD
Collaborators
Avania, Resvent Medical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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:
Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, sleep apnea, CPAP, PAP, APAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
RXiBreeze PAP System, Model RXiBreeze 20A
Intervention Type
Device
Intervention Name(s)
RXiBreeze PAP System, Model RXiBreeze 20A
Intervention Description
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.
Primary Outcome Measure Information:
Title
AHI Event Detection
Description
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.
Time Frame
Night 1
Title
Responder Rate
Description
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.
Time Frame
Night 1
Secondary Outcome Measure Information:
Title
Night 7 responder rate
Description
. 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.
Time Frame
Night 7
Title
Night 1 responder rate by baseline disease severity
Description
Responder rate presented by disease severity in accordance with AASM scoring guidelines. 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.
Time Frame
Night 1
Title
Night 7 RXiBreeze PAP System compliance rate
Description
Compliance rate is measure of subject use of the RXiBreeze PAP System presented by descriptive statistics.
Time Frame
Night 7
Title
Nights 1 and 7 Oxygen Desaturation Index (ODI)
Description
ODI is average number of desaturation episodes per hour. ODI will be presented by descriptive statistics.
Time Frame
Nights 1 and 7
Title
Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)
Description
Oxygen saturation is a measure of the amount of oxygen that is circulating in the blood. T90 oxygen saturation will be presented by descriptive statistics.
Time Frame
Nights 1 and 7
Title
Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7
Description
Obstructive Apnea Index (OAI) as measured by the test device (RXiBreeze PAP System) will be compared to the OAI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Time Frame
Nights 1 and 7
Title
Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7
Description
Event Detection Validation: Hypopnea Index (HI) as measured by the test device (RXiBreeze PAP System) will be compared to the HI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Time Frame
Nights 1 and 7
Title
Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7
Description
Event Detection Validation: Central Apnea Index (CAI) as measured by the test device (RXiBreeze PAP System) will be compared to the CAI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Time Frame
Nights 1 and 7
Title
Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7
Description
Event Detection Validation: Apnea Index (AI) as measured by the test device (RXiBreeze PAP System) will be compared to the AI as measured by polysomnography (PSG) to validate accuracy of the test device at nights 1 and 7. Frequency and percentages will be presented.
Time Frame
Nights 1 and 7
Title
Epworth Sleepiness Scale (ESS) on Night 1 and Night 7
Description
Epworth Sleepiness Scale (ESS) is a validated patient reported outcome (PRO) questionnaire consisting of 8 questions related to daytime sleepiness. The ESS results in a score from 0 to 24 (0 - 10 reflect normal levels of daytime sleepiness, scores over 10 reflect excessive daytime sleepiness (EDS), scores of 16 or more suggest a high level of EDS. The ESS will be self-administered by subjects at the Night 1 and Night 7 visits. Results will be presented by frequency and percentages.
Time Frame
Nights 1 and 7
Title
Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7
Description
Functional Outcomes of Sleep Questionnaire (FOSQ) short form is a validated patient reported outcome (PRO) questionnaire consisting of 10 questions related to the impact of sleepiness on the ability to conduct daily activities. The FOSQ-10 questions are rates on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty). A total score and 5 subscale scores (vigilance, general productivity, social outcome, intimacy, and activity level) are calculated. Subscale scores range from 1 (maximum difficulty) to 4 (no difficulty).
Time Frame
Nights 1 and 7
Other Pre-specified Outcome Measures:
Title
Safety Endpoint: Device- and/or therapy-related adverse events (AEs)
Description
Device- and/or therapy-related adverse events (AEs) will be collected from the Night 1 visit through completion of the Night 7 visit. AEs will be coded using the standardized Medical Dictionary for Regulatory Activities (MedDRA). AEs will be reported by subject and event.
Time Frame
Night 1 through completion of Night 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thuy Olender, BSN
Phone
408.832.9686
Email
tolender@maxismedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joelle Maddux, RPSGT
Phone
937.789.9446
Email
joelle.maddux@resvent.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehran Farid, MD
Organizational Affiliation
Peninsula Sleep Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peninsula Sleep Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Traci Nishino
Phone
650-779-4055
Email
traci@peninsulasleep.com
First Name & Middle Initial & Last Name & Degree
Mehran Farid, MD
Facility Name
NeuroTrials Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronna Harris
Phone
404-851-9934
Email
rharris@neurotrials.com
First Name & Middle Initial & Last Name & Degree
Russell Rosenberg, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28162150
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.
Results Reference
background
PubMed Identifier
8855039
Citation
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.
Results Reference
background
PubMed Identifier
31300334
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.
Results Reference
background
PubMed Identifier
18468315
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.
Results Reference
background
Learn more about this trial
Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
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