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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008678
• Other study ID #: KF-0611-6-0599
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2023
• Source: Resvent Medical Technology Co., Ltd.
• Contact: Thuy Olender, BSN
• Phone: 408.832.9686
• Email: tolender[@]maxismedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	NeuroTrials Research	Atlanta	Georgia
United States	Peninsula Sleep Center	Burlingame	California

Sponsors (3)

Lead Sponsor	Collaborator
Resvent Holding USA LTD	Avania, Resvent Medical Technology Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint: Device- and/or therapy-related adverse events (AEs)	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.	Night 1 through completion of Night 7
Primary	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
Primary	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	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 7
Secondary	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 1
Secondary	Night 7 RXiBreeze PAP System compliance rate	Compliance rate is measure of subject use of the RXiBreeze PAP System presented by descriptive statistics.	Night 7
Secondary	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
Secondary	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.	Nights 1 and 7
Secondary	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.	Nights 1 and 7
Secondary	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.	Nights 1 and 7
Secondary	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.	Nights 1 and 7
Secondary	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.	Nights 1 and 7
Secondary	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.	Nights 1 and 7
Secondary	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).	Nights 1 and 7