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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
146
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.
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
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.
Time frame: 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.
Time frame: Night 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Nights 1 and 7
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