<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/NCT01672606</url>
  </required_header>
  <id_info>
    <org_study_id>OSA ROC</org_study_id>
    <nct_id>NCT01672606</nct_id>
  </id_info>
  <brief_title>Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea</brief_title>
  <official_title>Effect of Partial Neuromuscular Blockade by Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea-before and After Three Month CPAP Treatment. A Non-randomized, Non-blinded Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malin Jonsson Fagerlund</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study describe the effect of partial neuromuscular blockade of rocuronium on the acute&#xD;
      hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypoxic ventilatory response</measure>
    <time_frame>At baseline, with CPAP, at TOF 0.70 and at TOF &gt;0.90. At diagnosis and after 3 month of CPAP treatment at home</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypercarbic ventilatory response</measure>
    <time_frame>At baseline, with CPAP, at TOF 0.70 and at TOF &gt;0.90. At diagnosis and after 3 month of CPAP treatment at home</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoxic ventilatory response</measure>
    <time_frame>At diagnosis and after 3 month of CPAP treatment at home</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoxic ventilatory response during acute CPAP treatment</measure>
    <time_frame>At diagnosis and after 3 month of CPAP treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypercarbic ventilatory response</measure>
    <time_frame>At diagnosis and after 3 month of CPAP treatment at home</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypercarbic ventilatory response during acute CPAP treatment</measure>
    <time_frame>At diagnosis and after 3 month CPAP treatment at home</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper airway obstruction</measure>
    <time_frame>At TOF 0.70 and TOF &gt;0.90. At diagnosis and after 3 month CPAP treatment.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>OSA</condition>
  <condition>Rocuronium</condition>
  <condition>Neuromuscular Blockade</condition>
  <condition>Hypoxic Ventilatory Response</condition>
  <condition>CPAP</condition>
  <arm_group>
    <arm_group_label>Rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion of rocuronium with the goal of TOF 0.70 and &gt;0.90</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Partial neuromuscular blockade with rocuronium with a TOF 0.70</description>
    <arm_group_label>Rocuronium</arm_group_label>
    <other_name>CPAP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP&#xD;
             treatment. Healthy except for OSA and well controlled tablet treated hypertension&#xD;
             where the treatment has not been changed during the last 3 month. None smokers. 18-70&#xD;
             years old. BMI &lt;35.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If they don´t fit the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malin Jonsson Fagerlund, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska University Hospital and Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>se-17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>June 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>February 26, 2016</last_update_submitted>
  <last_update_submitted_qc>February 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Malin Jonsson Fagerlund</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01672606
org study id: OSA ROC
nct id: NCT01672606
lead sponsor: 
has dmc: Yes
This study describe the effect of partial neuromuscular blockade of rocuronium on the acute
      hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Hypoxic ventilatory response
time frame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
measure: Hypercarbic ventilatory response
time frame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
measure: Hypoxic ventilatory response
time frame: At diagnosis and after 3 month of CPAP treatment at home
measure: Hypoxic ventilatory response during acute CPAP treatment
time frame: At diagnosis and after 3 month of CPAP treatment
measure: Hypercarbic ventilatory response
time frame: At diagnosis and after 3 month of CPAP treatment at home
measure: Hypercarbic ventilatory response during acute CPAP treatment
time frame: At diagnosis and after 3 month CPAP treatment at home
measure: Upper airway obstruction
time frame: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
arm group label: Rocuronium
arm group type: Experimental
description: Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90
intervention type: Drug
intervention name: Rocuronium
description: Partial neuromuscular blockade with rocuronium with a TOF 0.70
arm group label: Rocuronium
other name: CPAP
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Malin Jonsson Fagerlund, MD, PhD
role: Principal Investigator
affiliation: Karolinska University Hospital and Karolinska Institutet
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Malin Jonsson Fagerlund
investigator title: MD, PhD
mesh term: Sleep Apnea, Obstructive
mesh term: Hypoxia
mesh term: Rocuronium