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/NCT05978505</url>
    </required_header>
    <id_info>
      <org_study_id>2023/HRE00060</org_study_id>
      <nct_id>NCT05978505</nct_id>
    </id_info>
    <brief_title>Reboxetine for Sleep Apnoea After ENT Surgery</brief_title>
    <acronym>RENTOSA</acronym>
    <official_title>Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Flinders University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Flinders Medical Centre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Flinders University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot study will establish the feasibility of a larger trial to investigate whether&#xD;
        reboxetine, a medication used to treat depression, can reduce the severity of obstructive&#xD;
        sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where&#xD;
        positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an&#xD;
        option immediately post surgery. In this randomized, placebo-controlled, double-blind study,&#xD;
        participants will use at-home sleep monitoring equipment before and after surgery plus&#xD;
        measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven&#xD;
        days after surgery and complete questionnaires at the beginning and end of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>Double-blind, randomized, placebo-controlled, cross-over study</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Identical capsule for placebo and study drug prepared by study pharmacist</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment protocol adherence</measure>
      <time_frame>7 days</time_frame>
      <description>The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Data capture efficiency</measure>
      <time_frame>14 days</time_frame>
      <description>The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oxygen desaturation index (ODI)</measure>
      <time_frame>14 days</time_frame>
      <description>Number of times per hour that a participant has a drop in blood oxygen levels during sleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>nadir SpO2</measure>
      <time_frame>14 days</time_frame>
      <description>The lowest oxygen saturation value the patient drops to in a night.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time spent below 90% SpO2</measure>
      <time_frame>14 days</time_frame>
      <description>The total amount of time per night for which oxygen saturation falls below 90%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mean SpO2</measure>
      <time_frame>14 days</time_frame>
      <description>Average nightly oxygen level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep duration</measure>
      <time_frame>14 days</time_frame>
      <description>Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep efficiency (%)</measure>
      <time_frame>14 days</time_frame>
      <description>The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daytime sleepiness</measure>
      <time_frame>14 days</time_frame>
      <description>Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire</measure>
      <time_frame>14 days</time_frame>
      <description>This questionnaire asks participants to rate their perceived sleep across 4 domains on a visual analog scale as follows: 1) getting to sleep, 2) quality of sleep, 3) Awake following sleep, 4) Behavior following wakening. Higher scores indicate better perceived sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Score</measure>
      <time_frame>14 days</time_frame>
      <description>A patient-reported measure of insomnia symptoms using the Insomnia Severity Index- A 28 point scale where 0 indicates no clinically significant insomnia and 28 indicates maximally severe clinical insomnia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apnoea-hypopnea hndex (AHI)</measure>
      <time_frame>14 days</time_frame>
      <description>Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study enrolment rate</measure>
      <time_frame>12 months</time_frame>
      <description>The number of referred patients successfully enrolled into this feasibility study</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Reboxetine-related side effects</measure>
      <time_frame>14 days</time_frame>
      <description>Documented via adverse-event forms.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Sleep Apnea, Obstructive</condition>
    <arm_group>
      <arm_group_label>Reboxetine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Reboxetine 4 MG Oral Tablet</intervention_name>
      <description>7 nightly doses (4mg) to commence after surgery.</description>
      <arm_group_label>Reboxetine</arm_group_label>
      <other_name>Edronax</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>7 nightly doses to commence after surgery.</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Sugar pill</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;18 years&#xD;
  &#xD;
            -  Undergoing elective upper airway surgery&#xD;
  &#xD;
            -  History of obstructive sleep apnoea (OSA)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or&#xD;
               cardiac failure)&#xD;
  &#xD;
            -  History of clinically significant urinary retention, bladder outlet obstruction, or&#xD;
               benign prostatic hyperplasia&#xD;
  &#xD;
            -  Poorly controlled hypertension&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  History of schizophrenia, schizoaffective disorder or bipolar disorder according to&#xD;
               Diagnostic and Statistical Manual of Mental Disorders-V or International&#xD;
               Classification of Disease 10th edition criteria&#xD;
  &#xD;
            -  History of attempted suicide or suicidal ideation within 1 year prior to screening, or&#xD;
               current suicidal ideation&#xD;
  &#xD;
            -  Narrow angle glaucoma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Danny J Eckert, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Flinders University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emma J Thomas</last_name>
      <phone>+61 8 8201 2912</phone>
      <email>ethomas@flinders.edu.au</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carolin Tran</last_name>
      <phone>+61 8 7421 9873</phone>
      <email>carolin.tran@flinders.edu.au</email>
    </overall_contact_backup>
    <reference>
      <citation>Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.</citation>
      <PMID>27101493</PMID>
    </reference>
    <reference>
      <citation>Chan MTV, Wang CY, Seet E, Tam S, Lai HY, Chew EFF, Wu WKK, Cheng BCP, Lam CKM, Short TG, Hui DSC, Chung F; Postoperative Vascular Complications in Unrecognized Obstructive Sleep Apnea (POSA) Study Investigators. Association of Unrecognized Obstructive Sleep Apnea With Postoperative Cardiovascular Events in Patients Undergoing Major Noncardiac Surgery. JAMA. 2019 May 14;321(18):1788-1798. doi: 10.1001/jama.2019.4783.</citation>
      <PMID>31087023</PMID>
    </reference>
    <reference>
      <citation>Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.</citation>
      <PMID>32925318</PMID>
    </reference>
    <reference>
      <citation>Altree TJ, Eckert DJ. Obstructive sleep apnea endotypes and their postoperative relevance. Int Anesthesiol Clin. 2022 Apr 1;60(2):1-7. doi: 10.1097/AIA.0000000000000357. No abstract available.</citation>
      <PMID>35125480</PMID>
    </reference>
    <reference>
      <citation>Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040.</citation>
      <PMID>24158049</PMID>
    </reference>
    <reference>
      <citation>Chung F, Memtsoudis SG, Ramachandran SK, Nagappa M, Opperer M, Cozowicz C, Patrawala S, Lam D, Kumar A, Joshi GP, Fleetham J, Ayas N, Collop N, Doufas AG, Eikermann M, Englesakis M, Gali B, Gay P, Hernandez AV, Kaw R, Kezirian EJ, Malhotra A, Mokhlesi B, Parthasarathy S, Stierer T, Wappler F, Hillman DR, Auckley D. Society of Anesthesia and Sleep Medicine Guidelines on Preoperative Screening and Assessment of Adult Patients With Obstructive Sleep Apnea. Anesth Analg. 2016 Aug;123(2):452-73. doi: 10.1213/ANE.0000000000001416.</citation>
      <PMID>27442772</PMID>
    </reference>
    <reference>
      <citation>Liao P, Luo Q, Elsaid H, Kang W, Shapiro CM, Chung F. Perioperative auto-titrated continuous positive airway pressure treatment in surgical patients with obstructive sleep apnea: a randomized controlled trial. Anesthesiology. 2013 Oct;119(4):837-47. doi: 10.1097/ALN.0b013e318297d89a. Erratum In: Anesthesiology. 2014 May;120(5):1302. Anesthesiology. 2014 May;120(5):1302.</citation>
      <PMID>24195872</PMID>
    </reference>
    <reference>
      <citation>Altree TJ, Chung F, Chan MTV, Eckert DJ. Vulnerability to Postoperative Complications in Obstructive Sleep Apnea: Importance of Phenotypes. Anesth Analg. 2021 May 1;132(5):1328-1337. doi: 10.1213/ANE.0000000000005390.</citation>
      <PMID>33857975</PMID>
    </reference>
    <reference>
      <citation>Reilly EK, Boon MS, Vimawala S, Chitguppi C, Patel J, Murphy K, Doghramji K, Nyquist GG, Rosen MR, Rabinowitz MR, Huntley CT. Tolerance of Continuous Positive Airway Pressure After Sinonasal Surgery. Laryngoscope. 2021 Mar;131(3):E1013-E1018. doi: 10.1002/lary.28968. Epub 2020 Sep 16.</citation>
      <PMID>32936959</PMID>
    </reference>
    <reference>
      <citation>Perger E, Taranto Montemurro L, Rosa D, Vicini S, Marconi M, Zanotti L, Meriggi P, Azarbarzin A, Sands SA, Wellman A, Lombardi C, Parati G. Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial. Chest. 2022 Jan;161(1):237-247. doi: 10.1016/j.chest.2021.08.080. Epub 2021 Sep 20.</citation>
      <PMID>34543665</PMID>
    </reference>
    <reference>
      <citation>Taranto-Montemurro L, Messineo L, Sands SA, Azarbarzin A, Marques M, Edwards BA, Eckert DJ, White DP, Wellman A. The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial. Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276. doi: 10.1164/rccm.201808-1493OC.</citation>
      <PMID>30395486</PMID>
    </reference>
    <reference>
      <citation>Lim R, Messineo L, Grunstein RR, Carberry JC, Eckert DJ. The noradrenergic agent reboxetine plus the antimuscarinic hyoscine butylbromide reduces sleep apnoea severity: a double-blind, placebo-controlled, randomised crossover trial. J Physiol. 2021 Sep;599(17):4183-4195. doi: 10.1113/JP281912. Epub 2021 Jul 14.</citation>
      <PMID>34174090</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Flinders University</investigator_affiliation>
      <investigator_full_name>Professor Danny Eckert</investigator_full_name>
      <investigator_title>Director, Adelaide Institute for Sleep Health</investigator_title>
    </responsible_party>
    <keyword>sleep apnea, obstructive</keyword>
    <keyword>upper airway surgery</keyword>
    <keyword>ENT surgery</keyword>
    <keyword>reboxetine</keyword>
    <keyword>noradrenaline reuptake inhibitor</keyword>
    <keyword>randomised</keyword>
    <keyword>feasibility</keyword>
    <keyword>placebo</keyword>
    <keyword>double-blind</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Reboxetine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Participants will be informed in plain language through the consent form that their deidentified data may be made available to other researchers. Deidentified participant data will only be shared with other researchers upon request to the chief investigator after study publication and subject to ethical approval</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>At conclusion of the study and any related publications</ipd_time_frame>
      <ipd_access_criteria>IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.</ipd_access_criteria>
    </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/NCT05978505
  org study id: 2023/HRE00060
  nct id: NCT05978505
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This pilot study will establish the feasibility of a larger trial to investigate whether
        reboxetine, a medication used to treat depression, can reduce the severity of obstructive
        sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where
        positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an
        option immediately post surgery. In this randomized, placebo-controlled, double-blind study,
        participants will use at-home sleep monitoring equipment before and after surgery plus
        measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven
        days after surgery and complete questionnaires at the beginning and end of the study.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Double-blind, randomized, placebo-controlled, cross-over study
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Identical capsule for placebo and study drug prepared by study pharmacist
  measure: Treatment protocol adherence
  time frame: 7 days
  description: The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.
  measure: Data capture efficiency
  time frame: 14 days
  description: The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.
  measure: Oxygen desaturation index (ODI)
  time frame: 14 days
  description: Number of times per hour that a participant has a drop in blood oxygen levels during sleep
  measure: nadir SpO2
  time frame: 14 days
  description: The lowest oxygen saturation value the patient drops to in a night.
  measure: Time spent below 90% SpO2
  time frame: 14 days
  description: The total amount of time per night for which oxygen saturation falls below 90%.
  measure: mean SpO2
  time frame: 14 days
  description: Average nightly oxygen level
  measure: Sleep duration
  time frame: 14 days
  description: Total amount of time spent asleep per night, sleep tracking performed using an under mattress sensor device.
  measure: Sleep efficiency (%)
  time frame: 14 days
  description: The estimated percentage of time in bed spent asleep performed using an under mattress sensor device.
  measure: Daytime sleepiness
  time frame: 14 days
  description: Measured via Karolinska Sleepiness Scale Questionnaire (9 point scale where 1 = extremely alert and 9 = extremely sleepy - fighting sleep)
  measure: Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire
  time frame: 14 days
  description: This questionnaire asks participants to rate their perceived sleep across 4 domains on a visual analog scale as follows: 1) getting to sleep, 2) quality of sleep, 3) Awake following sleep, 4) Behavior following wakening. Higher scores indicate better perceived sleep.
  measure: Insomnia Severity Score
  time frame: 14 days
  description: A patient-reported measure of insomnia symptoms using the Insomnia Severity Index- A 28 point scale where 0 indicates no clinically significant insomnia and 28 indicates maximally severe clinical insomnia.
  measure: Apnoea-hypopnea hndex (AHI)
  time frame: 14 days
  description: Change in OSA severity (AHI estimated via the Withings under mattress sensor number of events/hour) between placebo and reboxetine
  measure: Study enrolment rate
  time frame: 12 months
  description: The number of referred patients successfully enrolled into this feasibility study
  measure: Reboxetine-related side effects
  time frame: 14 days
  description: Documented via adverse-event forms.
  arm group label: Reboxetine
  arm group type: Experimental
  description: 7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.
  intervention type: Drug
  intervention name: Reboxetine 4 MG Oral Tablet
  description: 7 nightly doses (4mg) to commence after surgery.
  arm group label: Reboxetine
  other name: Edronax
  intervention type: Drug
  intervention name: Placebo
  description: 7 nightly doses to commence after surgery.
  arm group label: Placebo
  other name: Sugar pill
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Danny J Eckert, PhD
  role: Principal Investigator
  affiliation: Flinders University
  last name: Emma J Thomas
  phone: +61 8 8201 2912
  email: ethomas@flinders.edu.au
  last name: Carolin Tran
  phone: +61 8 7421 9873
  email: carolin.tran@flinders.edu.au
  citation: Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.
  PMID: 27101493
  citation: Chan MTV, Wang CY, Seet E, Tam S, Lai HY, Chew EFF, Wu WKK, Cheng BCP, Lam CKM, Short TG, Hui DSC, Chung F; Postoperative Vascular Complications in Unrecognized Obstructive Sleep Apnea (POSA) Study Investigators. Association of Unrecognized Obstructive Sleep Apnea With Postoperative Cardiovascular Events in Patients Undergoing Major Noncardiac Surgery. JAMA. 2019 May 14;321(18):1788-1798. doi: 10.1001/jama.2019.4783.
  PMID: 31087023
  citation: Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
  PMID: 32925318
  citation: Altree TJ, Eckert DJ. Obstructive sleep apnea endotypes and their postoperative relevance. Int Anesthesiol Clin. 2022 Apr 1;60(2):1-7. doi: 10.1097/AIA.0000000000000357. No abstract available.
  PMID: 35125480
  citation: Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040.
  PMID: 24158049
  citation: Chung F, Memtsoudis SG, Ramachandran SK, Nagappa M, Opperer M, Cozowicz C, Patrawala S, Lam D, Kumar A, Joshi GP, Fleetham J, Ayas N, Collop N, Doufas AG, Eikermann M, Englesakis M, Gali B, Gay P, Hernandez AV, Kaw R, Kezirian EJ, Malhotra A, Mokhlesi B, Parthasarathy S, Stierer T, Wappler F, Hillman DR, Auckley D. Society of Anesthesia and Sleep Medicine Guidelines on Preoperative Screening and Assessment of Adult Patients With Obstructive Sleep Apnea. Anesth Analg. 2016 Aug;123(2):452-73. doi: 10.1213/ANE.0000000000001416.
  PMID: 27442772
  citation: Liao P, Luo Q, Elsaid H, Kang W, Shapiro CM, Chung F. Perioperative auto-titrated continuous positive airway pressure treatment in surgical patients with obstructive sleep apnea: a randomized controlled trial. Anesthesiology. 2013 Oct;119(4):837-47. doi: 10.1097/ALN.0b013e318297d89a. Erratum In: Anesthesiology. 2014 May;120(5):1302. Anesthesiology. 2014 May;120(5):1302.
  PMID: 24195872
  citation: Altree TJ, Chung F, Chan MTV, Eckert DJ. Vulnerability to Postoperative Complications in Obstructive Sleep Apnea: Importance of Phenotypes. Anesth Analg. 2021 May 1;132(5):1328-1337. doi: 10.1213/ANE.0000000000005390.
  PMID: 33857975
  citation: Reilly EK, Boon MS, Vimawala S, Chitguppi C, Patel J, Murphy K, Doghramji K, Nyquist GG, Rosen MR, Rabinowitz MR, Huntley CT. Tolerance of Continuous Positive Airway Pressure After Sinonasal Surgery. Laryngoscope. 2021 Mar;131(3):E1013-E1018. doi: 10.1002/lary.28968. Epub 2020 Sep 16.
  PMID: 32936959
  citation: Perger E, Taranto Montemurro L, Rosa D, Vicini S, Marconi M, Zanotti L, Meriggi P, Azarbarzin A, Sands SA, Wellman A, Lombardi C, Parati G. Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial. Chest. 2022 Jan;161(1):237-247. doi: 10.1016/j.chest.2021.08.080. Epub 2021 Sep 20.
  PMID: 34543665
  citation: Taranto-Montemurro L, Messineo L, Sands SA, Azarbarzin A, Marques M, Edwards BA, Eckert DJ, White DP, Wellman A. The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial. Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276. doi: 10.1164/rccm.201808-1493OC.
  PMID: 30395486
  citation: Lim R, Messineo L, Grunstein RR, Carberry JC, Eckert DJ. The noradrenergic agent reboxetine plus the antimuscarinic hyoscine butylbromide reduces sleep apnoea severity: a double-blind, placebo-controlled, randomised crossover trial. J Physiol. 2021 Sep;599(17):4183-4195. doi: 10.1113/JP281912. Epub 2021 Jul 14.
  PMID: 34174090
  responsible party type: Principal Investigator
  investigator affiliation: Flinders University
  investigator full name: Professor Danny Eckert
  investigator title: Director, Adelaide Institute for Sleep Health
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Reboxetine
  sharing ipd: Yes
  ipd description: Participants will be informed in plain language through the consent form that their deidentified data may be made available to other researchers. Deidentified participant data will only be shared with other researchers upon request to the chief investigator after study publication and subject to ethical approval
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: At conclusion of the study and any related publications
  ipd access criteria: IPD may be shared for research purposes on application to the chief investigator and subject to applicable ethical review.