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/NCT06006520</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar60</org_study_id>
      <nct_id>NCT06006520</nct_id>
    </id_info>
    <brief_title>Effects of Exercise on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome</brief_title>
    <official_title>Investigation of the Effects of Aerobic and Oropharyngeal Exercises on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        the investigators aim in this study is to investigate the effects of aerobic and&#xD;
        oropharyngeal exercises on sleep quality in patients with Obstructive Sleep Apnea Syndrome&#xD;
        (OSAS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted in a randomized controlled manner. Participants will be divided&#xD;
        into groups of 3 equal numbers using the simple randomization method. The control group will&#xD;
        not be given exercise. The first intervention group will be given 10-15 minutes of&#xD;
        oropharyngeal exercises. In addition to oropharyngeal exercises, the second intervention&#xD;
        group will be given 50 minutes of moderate-intensity aerobic exercise at least 3 days a week.&#xD;
        Both intervention groups will apply the given exercise program for 8 weeks. All participants&#xD;
        will be evaluated 3 times in total, at the beginning of the treatment, at the 4th week and at&#xD;
        the 8th week. Epworth Sleepiness Scale, Pittsburgh Sleep Quality Questionnaire, Fatigue&#xD;
        Severity Scale, Berlin Questionnaire, 6-minute walk test, Modified Medical Research Council&#xD;
        (MMRC) Dyspnea Scale, Functional Results of Sleep Scale (FOSQ) tests will be applied to the&#xD;
        participants. Pre- and post-intervention data were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>oropharyngeal exercises and aerobic exercises</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Epworth Sleepiness Scale</measure>
      <time_frame>10 weeks</time_frame>
      <description>It is used to measure the general sleepiness of people during the day. In Epworth Sleepiness Scale, 4 ratings are made for a total of 8 questions. The total score was 24, and more than 10 points were considered as daytime sleepiness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Survey</measure>
      <time_frame>10 weeks</time_frame>
      <description>The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Severity Scale</measure>
      <time_frame>10 weeks</time_frame>
      <description>The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Berlin Survey</measure>
      <time_frame>10 weeks</time_frame>
      <description>It is a questionnaire consisting of questions about snoring, daytime sleepiness, and high blood pressure, which have been shown to be risk factors for sleep apnea in previous sleep studies. Presence of snoring more than 3-4 times a week, presence of witnessed sleep apnea, daytime sleepiness more than 3-4 times a week and presence of at least two of the conditions were considered risky for sleep apnea syndrome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Outcomes of Sleep Scale (FOSQ)</measure>
      <time_frame>10 weeks</time_frame>
      <description>It is a test used to evaluate the physical, social and mental effects of excessive daytime sleepiness on daily life activities. In the Turkish version of the FOSQ, questions about sexual activities are excluded and it consists of 26 questions. Each question is evaluated as no difficulty, mild, moderate, extreme and scored between 0-4 points. Calculation of low scores in total indicates functional disability. Turkish validity and reliability have been demonstrated.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Osa Syndrome</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>No exercises will be given.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>oropharyngeal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>oropharyngeal exercises will be given.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>aerobic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to oropharyngeal exercises, 50 minutes of moderate-intensity aerobic exercise will be given at least 3 days a week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>No exercises will be given.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>oro-granary exercises.</intervention_name>
      <description>soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises</description>
      <arm_group_label>aerobic</arm_group_label>
      <arm_group_label>oropharyngeal</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>aerobic exercises</intervention_name>
      <description>We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; It includes activities such as walking, cycling, jogging, aerobic dancing, swimming.</description>
      <arm_group_label>aerobic</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People who want to participate in the study voluntarily&#xD;
  &#xD;
            -  People who do not regularly engage in physical activity&#xD;
  &#xD;
            -  Persons diagnosed with OSAS in the neurology outpatient clinic&#xD;
  &#xD;
            -  People between the ages of 18-45&#xD;
  &#xD;
            -  Apnea Hypopnea Index 5 ≤&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Chronic obstructive pulmonary disease, presence of lung disease that may cause&#xD;
               respiratory failure&#xD;
  &#xD;
            -  -Severe cardiac disease, congestive heart failure, detection of ejection fraction in&#xD;
               echocardiography, uncontrollable cardiac ischemia&#xD;
  &#xD;
            -  History of previous cerebrovascular disease&#xD;
  &#xD;
            -  Neuromuscular disease&#xD;
  &#xD;
            -  Presence of periodic leg movements&#xD;
  &#xD;
            -  Serious medical illness or planned surgical intervention&#xD;
  &#xD;
            -  Psychiatric illness, substance abuse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eda ARSLAN</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bolu</name>
        <address>
          <city>Bolu</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eda ARSLAN</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13.</citation>
      <PMID>33713177</PMID>
    </reference>
    <reference>
      <citation>Chwiesko-Minarowska S, Minarowski L, Kuryliszyn-Moskal A, Chwiesko J, Chyczewska E. Rehabilitation of patients with obstructive sleep apnea syndrome. Int J Rehabil Res. 2013 Dec;36(4):291-7. doi: 10.1097/MRR.0b013e3283643d5f.</citation>
      <PMID>23873222</PMID>
    </reference>
    <reference>
      <citation>Mohammadi H, Aarabi A, Rezaei M, Khazaie H, Brand S. Sleep Spindle Characteristics in Obstructive Sleep Apnea Syndrome (OSAS). Front Neurol. 2021 Feb 25;12:598632. doi: 10.3389/fneur.2021.598632. eCollection 2021.</citation>
      <PMID>33716919</PMID>
    </reference>
    <reference>
      <citation>Xanthopoulos MS, Berkowitz RI, Tapia IE. Effects of obesity therapies on sleep disorders. Metabolism. 2018 Jul;84:109-117. doi: 10.1016/j.metabol.2018.01.022. Epub 2018 Feb 1.</citation>
      <PMID>29409812</PMID>
    </reference>
    <reference>
      <citation>Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.</citation>
      <PMID>19234106</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>OSAS</keyword>
    <keyword>quality of life</keyword>
    <keyword>sleep</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
      <mesh_term>Syndrome</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/NCT06006520
  org study id: Uskudar60
  nct id: NCT06006520
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  the investigators aim in this study is to investigate the effects of aerobic and
        oropharyngeal exercises on sleep quality in patients with Obstructive Sleep Apnea Syndrome
        (OSAS).
  The study will be conducted in a randomized controlled manner. Participants will be divided
        into groups of 3 equal numbers using the simple randomization method. The control group will
        not be given exercise. The first intervention group will be given 10-15 minutes of
        oropharyngeal exercises. In addition to oropharyngeal exercises, the second intervention
        group will be given 50 minutes of moderate-intensity aerobic exercise at least 3 days a week.
        Both intervention groups will apply the given exercise program for 8 weeks. All participants
        will be evaluated 3 times in total, at the beginning of the treatment, at the 4th week and at
        the 8th week. Epworth Sleepiness Scale, Pittsburgh Sleep Quality Questionnaire, Fatigue
        Severity Scale, Berlin Questionnaire, 6-minute walk test, Modified Medical Research Council
        (MMRC) Dyspnea Scale, Functional Results of Sleep Scale (FOSQ) tests will be applied to the
        participants. Pre- and post-intervention data were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: oropharyngeal exercises and aerobic exercises
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Epworth Sleepiness Scale
  time frame: 10 weeks
  description: It is used to measure the general sleepiness of people during the day. In Epworth Sleepiness Scale, 4 ratings are made for a total of 8 questions. The total score was 24, and more than 10 points were considered as daytime sleepiness.
  measure: Pittsburgh Sleep Quality Survey
  time frame: 10 weeks
  description: The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.
  measure: Fatigue Severity Scale
  time frame: 10 weeks
  description: The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.
  measure: Berlin Survey
  time frame: 10 weeks
  description: It is a questionnaire consisting of questions about snoring, daytime sleepiness, and high blood pressure, which have been shown to be risk factors for sleep apnea in previous sleep studies. Presence of snoring more than 3-4 times a week, presence of witnessed sleep apnea, daytime sleepiness more than 3-4 times a week and presence of at least two of the conditions were considered risky for sleep apnea syndrome.
  measure: Functional Outcomes of Sleep Scale (FOSQ)
  time frame: 10 weeks
  description: It is a test used to evaluate the physical, social and mental effects of excessive daytime sleepiness on daily life activities. In the Turkish version of the FOSQ, questions about sexual activities are excluded and it consists of 26 questions. Each question is evaluated as no difficulty, mild, moderate, extreme and scored between 0-4 points. Calculation of low scores in total indicates functional disability. Turkish validity and reliability have been demonstrated.
  arm group label: control group
  arm group type: Active Comparator
  description: No exercises will be given.
  arm group label: oropharyngeal
  arm group type: Experimental
  description: oropharyngeal exercises will be given.
  arm group label: aerobic
  arm group type: Experimental
  description: In addition to oropharyngeal exercises, 50 minutes of moderate-intensity aerobic exercise will be given at least 3 days a week.
  intervention type: Other
  intervention name: control
  description: No exercises will be given.
  arm group label: control group
  intervention type: Other
  intervention name: oro-granary exercises.
  description: soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises
  arm group label: aerobic
  arm group label: oropharyngeal
  intervention type: Other
  intervention name: aerobic exercises
  description: We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; It includes activities such as walking, cycling, jogging, aerobic dancing, swimming.
  arm group label: aerobic
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Eda ARSLAN
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13.
  PMID: 33713177
  citation: Chwiesko-Minarowska S, Minarowski L, Kuryliszyn-Moskal A, Chwiesko J, Chyczewska E. Rehabilitation of patients with obstructive sleep apnea syndrome. Int J Rehabil Res. 2013 Dec;36(4):291-7. doi: 10.1097/MRR.0b013e3283643d5f.
  PMID: 23873222
  citation: Mohammadi H, Aarabi A, Rezaei M, Khazaie H, Brand S. Sleep Spindle Characteristics in Obstructive Sleep Apnea Syndrome (OSAS). Front Neurol. 2021 Feb 25;12:598632. doi: 10.3389/fneur.2021.598632. eCollection 2021.
  PMID: 33716919
  citation: Xanthopoulos MS, Berkowitz RI, Tapia IE. Effects of obesity therapies on sleep disorders. Metabolism. 2018 Jul;84:109-117. doi: 10.1016/j.metabol.2018.01.022. Epub 2018 Feb 1.
  PMID: 29409812
  citation: Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.
  PMID: 19234106
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Syndrome
  sharing ipd: No