<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/NCT02217397</url>
  </required_header>
  <id_info>
    <org_study_id>201402033RINC</org_study_id>
    <nct_id>NCT02217397</nct_id>
  </id_info>
  <brief_title>Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP</brief_title>
  <official_title>Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during&#xD;
      sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was&#xD;
      the standard therapy, especially those with daytime sleepiness and cardiovascular&#xD;
      comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high&#xD;
      pressure was often reported. Instead, oral appliance (OA) was the alternative for those who&#xD;
      could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in&#xD;
      compared with CPAP, but OA is more tolerable and acceptable in OSA patients.&#xD;
&#xD;
      Only one observation study addressed the effects of the combinations of OA and CPAP in OSA&#xD;
      patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA&#xD;
      patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP&#xD;
      intolerance according to the subjective chief complaint, not the objective CPAP pressure&#xD;
      data. In the present study, we studied the effects of combinations of CPAP and OA for&#xD;
      patients with severe OSA who could not tolerate CPAP with high-pressure setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study in a tertiary teaching hospital, National Taiwan University&#xD;
      Hospital. Patients are eligible with age ≧ 20 years old, severe OSA [apnea-hyponea index&#xD;
      (AHI) &gt;= 30/hr] who could not tolerate CPAP pressure &gt;15 cmH2O, determined by manual&#xD;
      titration (first titration) and willing to use OA.&#xD;
&#xD;
      The study designed was found out the patients with severe OSA (AHI &gt;= 30/hr ). With first&#xD;
      titration, the investigators excluded the severe OSA patients using CPAP (CPAP pressure &lt; 15&#xD;
      cmH2O) and could tolerate CPAP. Those patients who could not tolerance CPAP high pressure&#xD;
      setting started a three-month oral appliance trial. Then, the investigators repeated the&#xD;
      full-channel polysomnography (PSG) with second titration on those with residual AHI ≧ 10/hr&#xD;
      while patients were on OA. Therefore, those patients treated with combinations of OA and CPAP&#xD;
      for three months and then repeated the PSG. The washout period in each therapy was two weeks.&#xD;
      The total follow-up period is about 6 months after enrolled.&#xD;
&#xD;
      The investigators collected the demographic data from medical records and PSG data, including&#xD;
      age, gender, body mass index (BMI), CPAP titration, AHI, total sleep time, oxygen&#xD;
      desaturation, and arousal index…et al.&#xD;
&#xD;
      Our primary end point is the changes in AHI compared with combination therapy, and OA use.&#xD;
      The secondary end points are the difference in titrated CPAP pressure, BMI, blood pressure,&#xD;
      and daytime sleepiness compared with combination therapy and OA use.&#xD;
&#xD;
      Statistics analysis Data are presented as mean ± standard deviation (SD). Continuous&#xD;
      variables were tested by paired Student's t test in group comparisons. Statistical&#xD;
      significance was assumed when a null hypothesis could be rejected at p&lt;0.05. The&#xD;
      investigators compared the difference between combination therapy, OA, and baseline by ANOVA,&#xD;
      repeated measure. Statistical analysis was done using the SPSS 22.0 for Windows.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of AHI (Apnea Hypopnea Index ) in different treatment (baseline, OA, combination therapy)</measure>
    <time_frame>baseline and1, 3, 6 months later</time_frame>
    <description>The participants will be followed every month over out patient clinic with measures of change with AHI, sleep quality of life with different treatment (baseline, OA, combination treatment group).&#xD;
The investigators will record the AHI in different treatment group with OA, CPAP or combination therapy and read if AHI decreased after combination therapy use.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>OA, CPAPm, combination therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OA, CPAP, combination therapy</intervention_name>
    <arm_group_label>OA, CPAPm, combination therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. New diagnosed obstructive sleep apnea patients older than 20 years old&#xD;
&#xD;
          2. AHI more than 30/hr with moderate to severe obstructive sleep apnea&#xD;
&#xD;
          3. Willing to accept CPAP and OA treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. nasal problems causing CPAP intolerance&#xD;
&#xD;
          2. status post uvulopalatopharyngoplasty&#xD;
&#xD;
          3. alcohol abuse and dependence&#xD;
&#xD;
          4. life expectancy less than 6 months&#xD;
&#xD;
          5. severe cardiopulmonary distress.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peilin Lee, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Center of Sleep Disorder, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi-Chun Lai, MD</last_name>
    <phone>+886-2-23562755</phone>
    <email>toto881049@yahoo.com.tw</email>
  </overall_contact>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>March 16, 2015</last_update_submitted>
  <last_update_submitted_qc>March 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>Seep cencer, National Taiwan University Hospital</investigator_title>
  </responsible_party>
  <keyword>Apnea-hyponea Index, CPAP, Obstructive Sleep Apnea, Oral Appliance</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>
  </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/NCT02217397
org study id: 201402033RINC
nct id: NCT02217397
lead sponsor: 
has dmc: Yes
Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during
      sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was
      the standard therapy, especially those with daytime sleepiness and cardiovascular
      comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high
      pressure was often reported. Instead, oral appliance (OA) was the alternative for those who
      could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in
      compared with CPAP, but OA is more tolerable and acceptable in OSA patients.

      Only one observation study addressed the effects of the combinations of OA and CPAP in OSA
      patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA
      patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP
      intolerance according to the subjective chief complaint, not the objective CPAP pressure
      data. In the present study, we studied the effects of combinations of CPAP and OA for
      patients with severe OSA who could not tolerate CPAP with high-pressure setting.
This is a prospective study in a tertiary teaching hospital, National Taiwan University
      Hospital. Patients are eligible with age ≧ 20 years old, severe OSA [apnea-hyponea index
      (AHI) >= 30/hr] who could not tolerate CPAP pressure >15 cmH2O, determined by manual
      titration (first titration) and willing to use OA.

      The study designed was found out the patients with severe OSA (AHI >= 30/hr ). With first
      titration, the investigators excluded the severe OSA patients using CPAP (CPAP pressure < 15
      cmH2O) and could tolerate CPAP. Those patients who could not tolerance CPAP high pressure
      setting started a three-month oral appliance trial. Then, the investigators repeated the
      full-channel polysomnography (PSG) with second titration on those with residual AHI ≧ 10/hr
      while patients were on OA. Therefore, those patients treated with combinations of OA and CPAP
      for three months and then repeated the PSG. The washout period in each therapy was two weeks.
      The total follow-up period is about 6 months after enrolled.

      The investigators collected the demographic data from medical records and PSG data, including
      age, gender, body mass index (BMI), CPAP titration, AHI, total sleep time, oxygen
      desaturation, and arousal index…et al.

      Our primary end point is the changes in AHI compared with combination therapy, and OA use.
      The secondary end points are the difference in titrated CPAP pressure, BMI, blood pressure,
      and daytime sleepiness compared with combination therapy and OA use.

      Statistics analysis Data are presented as mean ± standard deviation (SD). Continuous
      variables were tested by paired Student's t test in group comparisons. Statistical
      significance was assumed when a null hypothesis could be rejected at p<0.05. The
      investigators compared the difference between combination therapy, OA, and baseline by ANOVA,
      repeated measure. Statistical analysis was done using the SPSS 22.0 for Windows.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The difference of AHI (Apnea Hypopnea Index ) in different treatment (baseline, OA, combination therapy)
time frame: baseline and1, 3, 6 months later
description: The participants will be followed every month over out patient clinic with measures of change with AHI, sleep quality of life with different treatment (baseline, OA, combination treatment group).
The investigators will record the AHI in different treatment group with OA, CPAP or combination therapy and read if AHI decreased after combination therapy use.
arm group label: OA, CPAPm, combination therapy
arm group type: Experimental
intervention type: Device
intervention name: OA, CPAP, combination therapy
arm group label: OA, CPAPm, combination therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peilin Lee, PhD
role: Study Director
affiliation: Center of Sleep Disorder, National Taiwan University Hospital
last name: Yi-Chun Lai, MD
phone: +886-2-23562755
email: toto881049@yahoo.com.tw
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: Seep cencer, National Taiwan University Hospital
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive