<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/NCT04451993</url>
  </required_header>
  <id_info>
    <org_study_id>GO 20/540</org_study_id>
    <nct_id>NCT04451993</nct_id>
  </id_info>
  <brief_title>Physical Activity Level in Patients With OSAS During Covid-19 Pandemic</brief_title>
  <official_title>Are the Sleep Quality and Physical Activity Levels of Osas Patients Differently From Healthy People During the COVID-19 Pandemic:a Prospective, Descriptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      As long as the people stay at home because of the Covid 19 outbreak, the investigators assume&#xD;
      that the sleep quality of OUAS patients, like everyone else, and the sleep quality of&#xD;
      COVID-19 outbreak are reduced due to anxiety and anxiety in people. In addition, we assume&#xD;
      that sleep quality and physical activity level are related to health literacy level and fear&#xD;
      of movement (kinesiophobia). In this study; the investigators aimed to determine how patients&#xD;
      are affected by this process by evaluating sleep quality, physical activity, fear of movement&#xD;
      and health literacy in OSAS patients during our stay in the COVID-19 outbreak.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Ahi Evren Chest Cardiovascular Surgery Training Research Hospital will be performed&#xD;
      in patients between the ages of 18-70 years, diagnosed with OSAS in the sleep laboratory.&#xD;
      Sleep quality, physical activity, fear of movement and health literacy will be evaluated in&#xD;
      OSAS patients. Evaluations will be made by phone In order for the study to be strong, it will&#xD;
      be tried to reach the maximum patient that can be taken between June 2020 and October 2020.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>1 day</time_frame>
    <description>International Physical Activity Questionnaire/ In activity-specific scoring, walking under the heading of the fields is calculated by the sum of the moderate intensity activity and intensive activity in itself.&#xD;
From these calculations, a score is obtained in MET-minutes. There are 3 categories of physical activity level classification. Physical activity levels are classified as physically inactive (inactive), low level of physical activity (minimally active) and sufficient level of physical activity (very active)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>1 day</time_frame>
    <description>The Pittsburgh Sleep Quality Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daytime Sleepiness</measure>
    <time_frame>1 day</time_frame>
    <description>In order to measure the general sleepiness of people during the day, it was evaluated with a standard questionnaire, which is defined as Epworth sleepiness scale (EUS) and consists of 8 questions. The answers for each question are scored between 0 and 3 and the total score is obtained. The score obtained above 10 in EUS has high sensitivity and specificity for daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement</measure>
    <time_frame>1 day</time_frame>
    <description>Tampa Kinesiophobia Scale (TKS)The person gets a total score between 17-68. The high score on the scale indicates that kinesiophobia is also high</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health literacy</measure>
    <time_frame>1 day</time_frame>
    <description>Translated into Turkish TURKEY health literacy SCALE-32 (Tsoy-32) will be used. It was used to evaluate the literacy rates of individuals over the age of 15.&#xD;
0 indicates the lowest health literacy and 50 indicates the highest health literacy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Circadian rhythm evaluation</measure>
    <time_frame>1 day</time_frame>
    <description>In the human circadian rhythm, the Morning Morning-Evening Survey (SAA) form was used, which determined morning and evening types.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">63</enrollment>
  <condition>Obstructive Sleep Apnea-hypopnea Syndrome</condition>
  <arm_group>
    <arm_group_label>OSAS PATIENTS</arm_group_label>
    <description>mild, moderate and severe OSAS patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HEALTHY INDIVIDUALS</arm_group_label>
    <description>healthy individuals without chronic disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and healthy individuals between 18-70 years old, who are diagnosed with OSAS in&#xD;
        the sleep lab at the Ahi Evren Chest, Heart and Vascular Surgery Training and Research&#xD;
        Hospital, and whose local language is Turkish will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having been diagnosed with OSAS and disease severity determined,&#xD;
&#xD;
          2. Being between the age of 19-70,&#xD;
&#xD;
          3. Body mass index &lt;40 kg / m2&#xD;
&#xD;
          4. Volunteering to participate in the research,&#xD;
&#xD;
          5. Not having a mental problem that will hinder the cooperation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. To have advanced orthopedic, neurological and cardiovascular disease,&#xD;
&#xD;
          2. Having a cognitive problem,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naciye Vardar-Yagli, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adem Celik, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital</name>
      <address>
        <city>Trabzon</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>NUREL ERTURK</investigator_full_name>
    <investigator_title>Phd student</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>COVID-19</keyword>
  <keyword>sleep quality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04451993
org study id: GO 20/540
nct id: NCT04451993
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As long as the people stay at home because of the Covid 19 outbreak, the investigators assume
      that the sleep quality of OUAS patients, like everyone else, and the sleep quality of
      COVID-19 outbreak are reduced due to anxiety and anxiety in people. In addition, we assume
      that sleep quality and physical activity level are related to health literacy level and fear
      of movement (kinesiophobia). In this study; the investigators aimed to determine how patients
      are affected by this process by evaluating sleep quality, physical activity, fear of movement
      and health literacy in OSAS patients during our stay in the COVID-19 outbreak.
Research Ahi Evren Chest Cardiovascular Surgery Training Research Hospital will be performed
      in patients between the ages of 18-70 years, diagnosed with OSAS in the sleep laboratory.
      Sleep quality, physical activity, fear of movement and health literacy will be evaluated in
      OSAS patients. Evaluations will be made by phone In order for the study to be strong, it will
      be tried to reach the maximum patient that can be taken between June 2020 and October 2020.
observational model: Case-Control
time perspective: Prospective
measure: Physical Activity
time frame: 1 day
description: International Physical Activity Questionnaire/ In activity-specific scoring, walking under the heading of the fields is calculated by the sum of the moderate intensity activity and intensive activity in itself.
From these calculations, a score is obtained in MET-minutes. There are 3 categories of physical activity level classification. Physical activity levels are classified as physically inactive (inactive), low level of physical activity (minimally active) and sufficient level of physical activity (very active)
measure: Sleep Quality
time frame: 1 day
description: The Pittsburgh Sleep Quality Index
measure: Daytime Sleepiness
time frame: 1 day
description: In order to measure the general sleepiness of people during the day, it was evaluated with a standard questionnaire, which is defined as Epworth sleepiness scale (EUS) and consists of 8 questions. The answers for each question are scored between 0 and 3 and the total score is obtained. The score obtained above 10 in EUS has high sensitivity and specificity for daytime sleepiness.
measure: Fear of movement
time frame: 1 day
description: Tampa Kinesiophobia Scale (TKS)The person gets a total score between 17-68. The high score on the scale indicates that kinesiophobia is also high
measure: Health literacy
time frame: 1 day
description: Translated into Turkish TURKEY health literacy SCALE-32 (Tsoy-32) will be used. It was used to evaluate the literacy rates of individuals over the age of 15.
0 indicates the lowest health literacy and 50 indicates the highest health literacy.
measure: Circadian rhythm evaluation
time frame: 1 day
description: In the human circadian rhythm, the Morning Morning-Evening Survey (SAA) form was used, which determined morning and evening types.
arm group label: OSAS PATIENTS
description: mild, moderate and severe OSAS patients
arm group label: HEALTHY INDIVIDUALS
description: healthy individuals without chronic disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naciye Vardar-Yagli, PhD
role: Study Director
affiliation: Hacettepe University
last name: Adem Celik, MD
role: Study Chair
affiliation: Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
investigator full name: NUREL ERTURK
investigator title: Phd student
mesh term: COVID-19
mesh term: Sleep Apnea, Obstructive
sharing ipd: No