<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/NCT03011294</url>
  </required_header>
  <id_info>
    <org_study_id>SDC 4165.14.145</org_study_id>
    <nct_id>NCT03011294</nct_id>
  </id_info>
  <brief_title>Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea</brief_title>
  <acronym>SLEEP-PARTNERS</acronym>
  <official_title>Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact&#xD;
      not limited to the patients but also to the partner that sleep in the same bed. Is it&#xD;
      reasonable to speculate that the partner suffer sleep deprivation, increased level of&#xD;
      irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA&#xD;
      patient. Although previous data reported impaired sleep quality in partners of patients with&#xD;
      OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the&#xD;
      treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the&#xD;
      improvements in the subjective and objective sleep. Thus, the main objectives of this&#xD;
      randomized controlled study are: to evaluate the impact of three months of randomization&#xD;
      (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure&#xD;
      (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and&#xD;
      sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of&#xD;
      patients with moderate to severe OSA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial function (forearm dilation, FMD - %)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep quantity (measured by actigraphy - hours/night)</measure>
    <time_frame>3 months</time_frame>
    <description>1 week of wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality (Pittsburgh Questionnaire)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory blood pressure monitoring (ABPM)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of OSA</measure>
    <time_frame>Baseline only</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sleep Apnea Syndromes</condition>
  <arm_group>
    <arm_group_label>CPAP (in the partner)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Positive airway pressure for treating OSA in the bed partner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal strips (in the partner)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Nasal dilator as a placebo for treating OSA in the bed partner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous positive airway pressure (CPAP)</intervention_name>
    <arm_group_label>CPAP (in the partner)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal strip</intervention_name>
    <arm_group_label>Nasal strips (in the partner)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bed partners of patients with moderate to severe OSA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bed partners with OSA using specific treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Luciano Drager</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Luciano F Drager, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <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>


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/NCT03011294
org study id: SDC 4165.14.145
nct id: NCT03011294
lead sponsor: 
has dmc: No
Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact
      not limited to the patients but also to the partner that sleep in the same bed. Is it
      reasonable to speculate that the partner suffer sleep deprivation, increased level of
      irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA
      patient. Although previous data reported impaired sleep quality in partners of patients with
      OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the
      treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the
      improvements in the subjective and objective sleep. Thus, the main objectives of this
      randomized controlled study are: to evaluate the impact of three months of randomization
      (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure
      (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and
      sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of
      patients with moderate to severe OSA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endothelial function (forearm dilation, FMD - %)
time frame: 3 months
measure: Sleep quantity (measured by actigraphy - hours/night)
time frame: 3 months
description: 1 week of wrist actigraphy
measure: Sleep quality (Pittsburgh Questionnaire)
time frame: 3 months
measure: Ambulatory blood pressure monitoring (ABPM)
time frame: 3 months
measure: Frequency of OSA
time frame: Baseline only
arm group label: CPAP (in the partner)
arm group type: Active Comparator
description: Positive airway pressure for treating OSA in the bed partner.
arm group label: Nasal strips (in the partner)
arm group type: Placebo Comparator
description: Nasal dilator as a placebo for treating OSA in the bed partner.
intervention type: Device
intervention name: Continuous positive airway pressure (CPAP)
arm group label: CPAP (in the partner)
intervention type: Device
intervention name: Nasal strip
arm group label: Nasal strips (in the partner)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Luciano F Drager, MD, PhD
investigator title: Associate Professor of Medicine
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No