xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06008678</url>
    </required_header>
    <id_info>
      <org_study_id>KF-0611-6-0599</org_study_id>
      <nct_id>NCT06008678</nct_id>
    </id_info>
    <brief_title>Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea</brief_title>
    <official_title>A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Resvent Holding USA LTD</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Avania</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Resvent Medical Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Resvent Medical Technology Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test the automatic positive airway pressure (APAP)&#xD;
        function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA).&#xD;
        The main questions the study aims to answer are:&#xD;
  &#xD;
          1. Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to&#xD;
             apnea-hypopnea index (AHI) detection using PSG?&#xD;
  &#xD;
          2. What is the responder rate using the RXiBreeze PAP System?&#xD;
  &#xD;
        Participants will use the APAP function of the RXiBreeze PAP System while undergoing&#xD;
        polysomnography (PSG) for two separate nights in a sleep center. During each visit,&#xD;
        participants will also complete two patient reported outcome questionnaires:&#xD;
  &#xD;
          -  Epworth Sleepiness Score (ESS); and&#xD;
  &#xD;
          -  Functional Outcomes of Sleep Questionnaire (FOSQ) short form.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, multicenter, single-arm trial designed to evaluate the safety and&#xD;
        effectiveness of the RXiBreeze PAP System to treat obstructive sleep apnea and detect&#xD;
        breathing events. Eligible subjects who meet all inclusion criteria and none of the exclusion&#xD;
        criteria will be consented for study participation. The study will enroll up to 68 subjects.&#xD;
        Baseline PSG will be obtained. Subjects will return to the sleep lab and use the RXiBreeze&#xD;
        PAP System while undergoing a PSG. The data from both the RXiBreeze PAP System and PSG from&#xD;
        both nights will be sent to an independent core lab for blinded AHI scoring. Data will be&#xD;
        evaluated in accordance with current American Academy of Sleep Medicine (AASM) scoring&#xD;
        guidelines. In addition to the device/PSG data scoring, subjects will complete the Epworth&#xD;
        Sleepiness Score (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) short form&#xD;
        (10 questions) and be assessed for device- and/or therapy-related adverse events (AEs) at the&#xD;
        end of each visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>single-arm trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AHI Event Detection</measure>
      <time_frame>Night 1</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Responder Rate</measure>
      <time_frame>Night 1</time_frame>
      <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 &lt; 20 events per hour.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Night 7 responder rate</measure>
      <time_frame>Night 7</time_frame>
      <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 &lt; 20 events per hour.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Night 1 responder rate by baseline disease severity</measure>
      <time_frame>Night 1</time_frame>
      <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 &lt; 20 events per hour.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Night 7 RXiBreeze PAP System compliance rate</measure>
      <time_frame>Night 7</time_frame>
      <description>Compliance rate is measure of subject use of the RXiBreeze PAP System presented by descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nights 1 and 7 Oxygen Desaturation Index (ODI)</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <description>ODI is average number of desaturation episodes per hour. ODI will be presented by descriptive statistics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nights 1 and 7 percentage of time oxygen saturation is &lt; 90% (T90)</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Epworth Sleepiness Scale (ESS) on Night 1 and Night 7</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7</measure>
      <time_frame>Nights 1 and 7</time_frame>
      <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).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Safety Endpoint: Device- and/or therapy-related adverse events (AEs)</measure>
      <time_frame>Night 1 through completion of Night 7</time_frame>
      <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.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>RXiBreeze PAP System, Model RXiBreeze 20A</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RXiBreeze PAP System, Model RXiBreeze 20A</intervention_name>
      <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.</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject is ≥ 22 years old&#xD;
  &#xD;
            2. Subject has been diagnosed with OSA (as scored per AASM scoring guidelines) and has an&#xD;
               AHI ≥ 10, based on the results of a sleep study conducted at an accredited sleep lab,&#xD;
               within 30 days prior to enrollment&#xD;
  &#xD;
            3. Subject weighs &gt;30 kg&#xD;
  &#xD;
            4. Subject has been prescribed the use of an Auto CPAP system&#xD;
  &#xD;
            5. Subject agrees to fulfill all study-required tests, sleep lab session attendance, and&#xD;
               assessments&#xD;
  &#xD;
            6. Subject agrees to use the RXiBreeze PAP System as prescribed&#xD;
  &#xD;
            7. Subject is willing and able to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject has been diagnosed with a sleep disorder other than OSA&#xD;
  &#xD;
            2. Subject's Central Apnea Index from the baseline PSG is &gt; 20% of AHI&#xD;
  &#xD;
            3. Subject has been diagnosed with severe (stage 3) coronary artery disease&#xD;
  &#xD;
            4. Subject has been diagnosed with bullous lung disease&#xD;
  &#xD;
            5. subject has been diagnosed with hypotension&#xD;
  &#xD;
            6. subject has been diagnosed with bypassed upper airway pneumothorax&#xD;
  &#xD;
            7. Subject is pregnant, breastfeeding, or planning on becoming pregnant during trial&#xD;
               participation&#xD;
  &#xD;
            8. Subject, in the opinion of the investigator, is not suitable for trial participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mehran Farid, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peninsula Sleep Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thuy Olender, BSN</last_name>
      <phone>408.832.9686</phone>
      <email>tolender@maxismedical.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joelle Maddux, RPSGT</last_name>
      <phone>937.789.9446</phone>
      <email>joelle.maddux@resvent.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peninsula Sleep Center</name>
        <address>
          <city>Burlingame</city>
          <state>California</state>
          <zip>94010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Traci Nishino</last_name>
        <phone>650-779-4055</phone>
        <email>traci@peninsulasleep.com</email>
      </contact>
      <investigator>
        <last_name>Mehran Farid, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>NeuroTrials Research</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30328</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ronna Harris</last_name>
        <phone>404-851-9934</phone>
        <email>rharris@neurotrials.com</email>
      </contact>
      <investigator>
        <last_name>Russell Rosenberg, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>28162150</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>8855039</PMID>
    </reference>
    <reference>
      <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>
      <PMID>31300334</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>18468315</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>obstructive sleep apnea</keyword>
    <keyword>sleep apnea</keyword>
    <keyword>CPAP</keyword>
    <keyword>PAP</keyword>
    <keyword>APAP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06008678
  org study id: KF-0611-6-0599
  nct id: NCT06008678
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: single-arm trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AHI Event Detection
  time frame: Night 1
  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.
  measure: Responder Rate
  time frame: Night 1
  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.
  measure: Night 7 responder rate
  time frame: Night 7
  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.
  measure: Night 1 responder rate by baseline disease severity
  time frame: Night 1
  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.
  measure: Night 7 RXiBreeze PAP System compliance rate
  time frame: Night 7
  description: Compliance rate is measure of subject use of the RXiBreeze PAP System presented by descriptive statistics.
  measure: Nights 1 and 7 Oxygen Desaturation Index (ODI)
  time frame: Nights 1 and 7
  description: ODI is average number of desaturation episodes per hour. ODI will be presented by descriptive statistics.
  measure: Nights 1 and 7 percentage of time oxygen saturation is < 90% (T90)
  time frame: Nights 1 and 7
  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.
  measure: Event Detection Validation - Obstructive Apnea Index (OAI) on Night 1 and Night 7
  time frame: Nights 1 and 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.
  measure: Event Detection Validation: Hypopnea Index (HI) on Night 1 and Night 7
  time frame: Nights 1 and 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.
  measure: Event Detection Validation: Central Apnea Index (CAI) on Night 1 and Night 7
  time frame: Nights 1 and 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.
  measure: Event Detection Validation: Apnea Index (AI) on Night 1 and Night 7
  time frame: Nights 1 and 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.
  measure: Epworth Sleepiness Scale (ESS) on Night 1 and Night 7
  time frame: Nights 1 and 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.
  measure: Functional Outcomes of Sleep Questionnaire short form (FOSQ-10) on Night 1 and Night 7
  time frame: Nights 1 and 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).
  measure: Safety Endpoint: Device- and/or therapy-related adverse events (AEs)
  time frame: Night 1 through completion of Night 7
  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.
  arm group label: Treatment
  arm group type: Other
  description: RXiBreeze PAP System, Model RXiBreeze 20A
  intervention type: Device
  intervention name: RXiBreeze PAP System, Model RXiBreeze 20A
  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.
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mehran Farid, MD
  role: Principal Investigator
  affiliation: Peninsula Sleep Center
  last name: Thuy Olender, BSN
  phone: 408.832.9686
  email: tolender@maxismedical.com
  last name: Joelle Maddux, RPSGT
  phone: 937.789.9446
  email: joelle.maddux@resvent.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  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.
  PMID: 28162150
  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.
  PMID: 8855039
  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.
  PMID: 31300334
  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.
  PMID: 18468315
  responsible party type: Sponsor
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  sharing ipd: No