<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/NCT02251574</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001418</org_study_id>
    <nct_id>NCT02251574</nct_id>
  </id_info>
  <brief_title>Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults</brief_title>
  <official_title>Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effectiveness of two different weight loss diets on&#xD;
      obstructive sleep apnea (OSA) severity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep.&#xD;
      The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your&#xD;
      throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring.&#xD;
      OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular&#xD;
      disease, and high blood pressure.&#xD;
&#xD;
      Although anyone can develop OSA, it commonly affects people who are obese. The more someone&#xD;
      weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for&#xD;
      overweight individuals to help improve OSA. However, not enough research has been done for&#xD;
      doctors to be able make specific recommendations to their patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Apnea Hypopnea Index (AHI)</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Apnea Hypopnea Index (AHI)</measure>
    <time_frame>Change from Baseline to Month 9</time_frame>
    <description>The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in metabolic syndrome (MetS) risk factors</measure>
    <time_frame>Change from Baseline to Month 3 and Month 9</time_frame>
    <description>Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Change from Baseline to Month 3 and Month 9</time_frame>
    <description>Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Daytime Sleepiness</measure>
    <time_frame>Change from Baseline to Month 3 and Month 9</time_frame>
    <description>Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Low Calorie Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Very Low Calorie Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive normal care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Calorie Diet</intervention_name>
    <description>Weight management program designed around a low calorie diet.</description>
    <arm_group_label>Low Calorie Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Very Low Calorie Diet</intervention_name>
    <description>Weight management program designed around a very low calorie diet.</description>
    <arm_group_label>Very Low Calorie Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Care provided that would normally be given to people meeting eligibility criteria for this study.</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AHI score of ≥ 5&#xD;
&#xD;
          -  Body mass index (BMI) between 30 to 49.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Report serious medical risk such as insulin-dependent diabetes, active cancer, recent&#xD;
             cardiac event&#xD;
&#xD;
          -  Currently or planning to become pregnant during the next 9 months&#xD;
&#xD;
          -  Not weight stable (-4.6 kg) for 3 mos. prior to intake&#xD;
&#xD;
          -  Report current participation in a weight reduction program involving diet or PA&#xD;
&#xD;
          -  Unwilling to be randomized to 1 of 3 study groups&#xD;
&#xD;
          -  Report symptomology of an eating disorder as determined by the Eating Attitudes Test&#xD;
&#xD;
          -  Unable to participate in moderate intensity physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeannine Goetz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <!-- 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/NCT02251574
org study id: STUDY00001418
nct id: NCT02251574
lead sponsor: 
has dmc: No
The purpose of this study is to test the effectiveness of two different weight loss diets on
      obstructive sleep apnea (OSA) severity.
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep.
      The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your
      throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring.
      OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular
      disease, and high blood pressure.

      Although anyone can develop OSA, it commonly affects people who are obese. The more someone
      weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for
      overweight individuals to help improve OSA. However, not enough research has been done for
      doctors to be able make specific recommendations to their patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Apnea Hypopnea Index (AHI)
time frame: Change from Baseline to Month 3
description: The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
measure: Change in Apnea Hypopnea Index (AHI)
time frame: Change from Baseline to Month 9
description: The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
measure: Change in metabolic syndrome (MetS) risk factors
time frame: Change from Baseline to Month 3 and Month 9
description: Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
measure: Change in Quality of Life
time frame: Change from Baseline to Month 3 and Month 9
description: Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.
measure: Change in Daytime Sleepiness
time frame: Change from Baseline to Month 3 and Month 9
description: Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant.
arm group label: Low Calorie Diet
arm group type: Experimental
description: Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
arm group label: Very Low Calorie Diet
arm group type: Experimental
description: Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
arm group label: Standard Care
arm group type: Active Comparator
description: Participants will receive normal care.
intervention type: Other
intervention name: Low Calorie Diet
description: Weight management program designed around a low calorie diet.
arm group label: Low Calorie Diet
intervention type: Other
intervention name: Very Low Calorie Diet
description: Weight management program designed around a very low calorie diet.
arm group label: Very Low Calorie Diet
intervention type: Other
intervention name: Standard Care
description: Care provided that would normally be given to people meeting eligibility criteria for this study.
arm group label: Standard Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeannine Goetz, PhD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive