Obstructive Sleep ApneaNCT06008678

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

A study testing RXiBreeze PAP System, Model RXiBreeze 20A in people with Obstructive Sleep Apnea, run by Resvent Holding USA LTD at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: RXiBreeze PAP System, Model RXiBreeze 20A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 9 sitesUnited States
Study dates: 22 Aug 2023to 29 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

NeuroTrials Research
Atlanta, Georgia, 30328
Peninsula Sleep Center
Burlingame, California, 94010
Exalt Clinical Research
Chula Vista, California, 91910
Intrepid Research
Cincinnati, Ohio, 45240
Somnos Clinical Research
Lincoln, Nebraska, 68510
Bay Sleep Clinic
Mountain View, California, 94040
Innovative Sleep Centers, Inc.
Redding, California, 96003
TriValley Sleep Center
San Ramon, California, 94583
Innovative Sleep Centers, PLLC
Tumwater, Washington, 98510

Other trials in United States

About this study

Official title: A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea

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.

Read the 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.

Conditions: Obstructive Sleep Apnea
Being tested: RXiBreeze PAP System, Model RXiBreeze 20A
Keywords: obstructive sleep apnea, sleep apnea, CPAP, PAP, APAP
Medical subject headings: Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RXiBreeze PAP System, Model RXiBreeze 20ADevice
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.

Study groups in NCT06008678
Study group	Role	What they receive
Treatment	Other	RXiBreeze PAP System, Model RXiBreeze 20A Receives: Device: RXiBreeze PAP System, Model RXiBreeze 20A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Night 1

Secondary outcomes (11)

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.
Measured: Night 7
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.
Measured: Night 1
Night 7 RXiBreeze PAP System compliance rate
Compliance rate is measure of subject use of the RXiBreeze PAP System presented by descriptive statistics.
Measured: Night 7
Nights 1 and 7 Oxygen Desaturation Index (ODI)
ODI is average number of desaturation episodes per hour. ODI will be presented by descriptive statistics.
Measured: Nights 1 and 7
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.
Measured: Nights 1 and 7
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.
Measured: Nights 1 and 7
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.
Measured: Nights 1 and 7
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.
Measured: Nights 1 and 7
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.
Measured: Nights 1 and 7
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.
Measured: Nights 1 and 7
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).
Measured: Nights 1 and 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 202329 Nov 2023

First posted23 Aug 2023
Study start22 Aug 2023
Primary completion22 Nov 2023
Study completion29 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: single-arm trial
Masking: None (open label)
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06008678
Sponsor's protocol ID: KF-0611-6-0599
Status last verified: Nov 2024
First submitted: 11 Aug 2023
Last updated: 2 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 28162150
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.
PubMed 8855039
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.
PubMed 31300334
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.
PubMed 18468315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT06008678
Acronym / sponsor ID: KF-0611-6-0599
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea, sleep apnea, CPAP, PAP, APAP
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: Resvent Holding USA LTDIndustry (pharma, biotech, devices)
Collaborators: Avania, Resvent Medical Technology Co., Ltd.
Study start: 22 Aug 2023 (actual)
Primary completion: 22 Nov 2023 (actual)
Study completion: 29 Nov 2023 (actual)
First posted: 23 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: single-arm trial

Arm	Type	Receives
Treatment	Other	Device: RXiBreeze PAP System, Model RXiBreeze 20ARXiBreeze PAP System, Model RXiBreeze 20A

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RXiBreeze PAP System, Model RXiBreeze 20AThe 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.	Device	Treatment

Primary outcome

AHI Event Detection
Time frame: Night 1
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
Time frame: Night 1
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.

11 secondary outcomes

Night 7 responder rate
Time frame: Night 7
Night 1 responder rate by baseline disease severity
Time frame: Night 1
Night 7 RXiBreeze PAP System compliance rate
Time frame: Night 7
Nights 1 and 7 Oxygen Desaturation Index (ODI)
Time frame: Nights 1 and 7
Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)
Time frame: Nights 1 and 7
Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7
Time frame: Nights 1 and 7
Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7
Time frame: Nights 1 and 7
Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7
Time frame: Nights 1 and 7
Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7
Time frame: Nights 1 and 7
Epworth Sleepiness Scale (ESS) on Night 1 and Night 7
Time frame: Nights 1 and 7
Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7
Time frame: Nights 1 and 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Background: PubMed 28162150Kapur 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.
Background: PubMed 8855039Sher 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.
Background: PubMed 31300334Benjafield 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.
Background: PubMed 18468315Kushida 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.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mehran Farid, MD principal investigator

Peninsula Sleep Center

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RXiBreeze PAP System, Model RXiBreeze 20A in people with Obstructive Sleep Apnea, run by Resvent Holding USA LTD at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AHI Event Detection (time frame: Night 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008678, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.