<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/NCT04454242</url>
  </required_header>
  <id_info>
    <org_study_id>2020/09</org_study_id>
    <nct_id>NCT04454242</nct_id>
  </id_info>
  <brief_title>High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome</brief_title>
  <official_title>Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Scientific and Technological Research Council of Turkey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity,&#xD;
      and respiratory muscle strength has been previously investigated in OSA syndrom. Only the&#xD;
      effects of the high-intensity short-term EMST study in moderate OSAS patients were studied.&#xD;
      High intensity and low intensity EMST has advantages and disadvantages.The study aims to&#xD;
      compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training&#xD;
      (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life&#xD;
      in severe OSAS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab,&#xD;
      polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS&#xD;
      patients. Patients will be divided into two groups by block randomization method. The study&#xD;
      was planned as double-blind. Patients will not know what treatment they are receiving, the&#xD;
      doctor does not know what treatment the patient is receiving, and technicians who take and&#xD;
      analyze polysomnography will not know what treatment the patients are receiving.&#xD;
&#xD;
      Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high&#xD;
      intensity) to the second group with expiratory muscle training device, 7 days / week, 25&#xD;
      breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will&#xD;
      take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP&#xD;
      measurements will be repeated every 2 weeks in the hospital and the new training workload&#xD;
      will be calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease severity</measure>
    <time_frame>2 day</time_frame>
    <description>Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>5 day</time_frame>
    <description>Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daytime sleepiness</measure>
    <time_frame>2 day</time_frame>
    <description>Epworth Sleepiness Scale (ESS). Minimum and maximum scores: 0-24. The higher ESS score means the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Snoring severitiy and frequency</measure>
    <time_frame>2 day</time_frame>
    <description>Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>2 day</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue severity.</measure>
    <time_frame>2 day</time_frame>
    <description>Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Antropometric measurements</measure>
    <time_frame>2 day</time_frame>
    <description>Neck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>L-EMST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths.&#xD;
Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>H-EMST</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 weeks will be trained with a 1-minute rest cycle in 5 breaths.&#xD;
Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Expiratory muscle trainig</intervention_name>
    <description>This exercise will be used to strengthen forced expiratory muscles.</description>
    <arm_group_label>H-EMST</arm_group_label>
    <arm_group_label>L-EMST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest,&#xD;
             Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.&#xD;
&#xD;
          2. General health condition is stable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Passed stroke,&#xD;
&#xD;
          2. Neurological disease and psychological disease&#xD;
&#xD;
          3. Cardiac disease&#xD;
&#xD;
          4. Hypothyroidism&#xD;
&#xD;
          5. Serious obstructive nasal disease,&#xD;
&#xD;
          6. A history of infection in the past month.&#xD;
&#xD;
          7. Previous oroferengeal surgery history&#xD;
&#xD;
          8. With a BMI of 40 kg / m2 or more,&#xD;
&#xD;
          9. Using substance, alcohol, sedative and hypnotic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebru Calik-Kutukcu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</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>January 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</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>Clinical Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Expiratory muscle strength training</keyword>
  <keyword>Snoring</keyword>
  <keyword>Sleep quality</keyword>
  <keyword>EMST</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>
    <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>


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/NCT04454242
org study id: 2020/09
nct id: NCT04454242
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity,
      and respiratory muscle strength has been previously investigated in OSA syndrom. Only the
      effects of the high-intensity short-term EMST study in moderate OSAS patients were studied.
      High intensity and low intensity EMST has advantages and disadvantages.The study aims to
      compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training
      (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life
      in severe OSAS patients.
Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab,
      polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS
      patients. Patients will be divided into two groups by block randomization method. The study
      was planned as double-blind. Patients will not know what treatment they are receiving, the
      doctor does not know what treatment the patient is receiving, and technicians who take and
      analyze polysomnography will not know what treatment the patients are receiving.

      Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high
      intensity) to the second group with expiratory muscle training device, 7 days / week, 25
      breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will
      take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP
      measurements will be repeated every 2 weeks in the hospital and the new training workload
      will be calculated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Disease severity
time frame: 2 day
description: Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity
measure: Respiratory muscle strength
time frame: 5 day
description: Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
measure: Daytime sleepiness
time frame: 2 day
description: Epworth Sleepiness Scale (ESS). Minimum and maximum scores: 0-24. The higher ESS score means the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'
measure: Snoring severitiy and frequency
time frame: 2 day
description: Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
measure: Sleep quality
time frame: 2 day
description: The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
measure: Fatigue severity.
time frame: 2 day
description: Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
measure: Antropometric measurements
time frame: 2 day
description: Neck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method
arm group label: L-EMST
arm group type: Experimental
description: At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths.
Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement.
arm group label: H-EMST
arm group type: Active Comparator
description: In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 weeks will be trained with a 1-minute rest cycle in 5 breaths.
Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement.
intervention type: Other
intervention name: Expiratory muscle trainig
description: This exercise will be used to strengthen forced expiratory muscles.
arm group label: H-EMST
arm group label: L-EMST
criteria: 
gender: All
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ebru Calik-Kutukcu, PhD
role: Study Director
affiliation: Hacettepe University
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: Clinical Physiotherapist
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome
sharing ipd: No