<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/NCT02242617</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01215</org_study_id>
    <secondary_id>RN325361</secondary_id>
    <nct_id>NCT02242617</nct_id>
  </id_info>
  <brief_title>Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial</brief_title>
  <acronym>CHOICE</acronym>
  <official_title>Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians.&#xD;
      It is the cause of significant healthcare costs with increased morbidity and mortality. The&#xD;
      two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic&#xD;
      Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both&#xD;
      therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance,&#xD;
      cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness&#xD;
      and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use.&#xD;
      Until now, studies have used self-reported adherence data on MAS versus objective adherence&#xD;
      on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is&#xD;
      counterbalanced by the superior adherence relative to PAP, resulting in a similar&#xD;
      effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS and&#xD;
      could be used to prove this hypothesis and allow a new and complete comparison of&#xD;
      effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's&#xD;
      objective adherence and long-term symptomatic improvement would provide vital information to&#xD;
      doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will&#xD;
      receive both PAP and MAS in a random sequence. This innovative study lead by two experienced&#xD;
      new investigators, and a research team of multidisciplinary experts, will assess objective&#xD;
      adherence, treatment efficacy, patient preference, sleepiness and quality of life of each&#xD;
      treatment used at home for 1 month per treatment. After this, patients will be able to go&#xD;
      back and forth between both treatments during an additional 6-month period. The results of&#xD;
      this study will be used by healthcare policy makers as well as clinicians who need to be part&#xD;
      of the treatment plan decision for the many Canadians who suffer from sleep apnea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to assess objective adherence to treatment, for PAP and MAS,&#xD;
      and to evaluate if there will be similar effectiveness (efficacy+adherence) between PAP and&#xD;
      MAS treatment for patients with mild to severe OSA. The secondary aim is to assess if patient&#xD;
      preference does correlate to the final treatment adherence. An exploratory aim is to assess&#xD;
      if the strategy of patients having both treatments available to use interchangeably could&#xD;
      further improve treatment adherence, sleepiness, quality of life and fatigue. Having a better&#xD;
      insight into patient adherence will improve the cost-effectiveness of treatment and will&#xD;
      improve the health and quality of life for many Canadians who suffer from sleep apnea.&#xD;
&#xD;
      The proposed trial is a randomized open-label, two-treatment, two-period cross-over trial&#xD;
      followed by an observational trial. Sixty OSA patients (10≤AHI≤50) will receive both PAP and&#xD;
      MAS. As a recent innovation, we have adherence monitors for MAS that can give a new and&#xD;
      comprehensive comparative analysis of the effectiveness between MAS and PAP. In the&#xD;
      randomized trial phase the two treatments will be used separately for 1 month each (after&#xD;
      treatment adaptation/titration of 1-2 months for each device). Treatment efficacy and daily&#xD;
      treatment use data will be assessed together with changes in symptoms (quality of life,&#xD;
      sleepiness and fatigue). Patient initial preference will be determined by using a patient&#xD;
      decision aid. This will be followed by the observational trial phase, where all patients will&#xD;
      have access to both interventions at home for 6 months and be allowed to choose on a daily&#xD;
      basis the intervention to use. The intervention duration of 6 months is to allow for a&#xD;
      sustained response in long-term adherence and to observe changes in quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">June 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objectively measured adherence (hours/night and nights/week of intervention use).</measure>
    <time_frame>At 1 month in the MAS treatment arm</time_frame>
    <description>Measuring objective adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objectively measured adherence (hours/night and nights/week of intervention use).</measure>
    <time_frame>At 1 month in CPAP treatment arm</time_frame>
    <description>Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objectively measured adherence (hours/night and nights/week of intervention use).</measure>
    <time_frame>At 1 month of using both treatments interchangeably.</time_frame>
    <description>Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objectively measured adherence (hours/night and nights/week of intervention use).</measure>
    <time_frame>At 6 months of using both treatments interchangeably</time_frame>
    <description>Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apnea-hypopnea index</measure>
    <time_frame>At baseline</time_frame>
    <description>Measuring apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire (FOSQ) responses</measure>
    <time_frame>At baseline</time_frame>
    <description>Measuring Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS) questionnaire responses.</measure>
    <time_frame>At baseline</time_frame>
    <description>Measuring responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chalder fatigue scale questionnaire responses</measure>
    <time_frame>At baseline</time_frame>
    <description>Measuring responses to the Chalder fatigue scale which assesses fatigue in the present state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 survey responses</measure>
    <time_frame>At baseline</time_frame>
    <description>Measuring SF-36 survey responses which assesses general health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apnea-hypopnea index</measure>
    <time_frame>At 1 month in MAS treatment arm</time_frame>
    <description>Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apnea-hypopnea index</measure>
    <time_frame>At 1 month in CPAP treatment arm</time_frame>
    <description>Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire (FOSQ) responses.</measure>
    <time_frame>At 1 month in MAS treatment arm</time_frame>
    <description>Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire (FOSQ) responses.</measure>
    <time_frame>At 1 month of using both treatments interchangeably</time_frame>
    <description>Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire (FOSQ) responses</measure>
    <time_frame>At 6 months of using both treatments interchangeably</time_frame>
    <description>Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire (FOSQ) responses.</measure>
    <time_frame>At 1 month in CPAP treatment arm</time_frame>
    <description>Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS) questionnaire responses.</measure>
    <time_frame>At 1 month in MAS treatment arm</time_frame>
    <description>Measuring changes in Epworth Sleepiness Scale (ESS) Questionnaire responses to compare daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS) questionnaire responses.</measure>
    <time_frame>At 1 month in CPAP treatment arm.</time_frame>
    <description>Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS) questionnaire responses</measure>
    <time_frame>At 1 month of using both treatments interchangeably</time_frame>
    <description>Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS) questionnaire responses.</measure>
    <time_frame>At 6 months of using both treatments interchangeably.</time_frame>
    <description>Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chalder fatigue scale questionnaire responses</measure>
    <time_frame>At 1 month in MAS treatment arm</time_frame>
    <description>Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chalder fatigue scale questionnaire responses</measure>
    <time_frame>At 1 month in CPAP treatment arm</time_frame>
    <description>Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chalder fatigue scale questionnaire responses</measure>
    <time_frame>At 1 month of using both treatments interchangeably</time_frame>
    <description>Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chalder fatigue scale questionnaire responses</measure>
    <time_frame>At 6 months of using both treatments interchangeably.</time_frame>
    <description>Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 survey responses.</measure>
    <time_frame>At 1 month in MAS treatment arm</time_frame>
    <description>Measuring changes in SF-36 survey responses which assesses general health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 survey responses.</measure>
    <time_frame>At 1 month in CPAP treatment arm.</time_frame>
    <description>Measuring changes in SF-36 survey responses which assesses general health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 survey responses.</measure>
    <time_frame>At 1 month of using both treatments interchangeably.</time_frame>
    <description>Measuring changes in SF-36 survey responses which assesses general health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 survey responses.</measure>
    <time_frame>At 6 months of using both treatments interchangeably.</time_frame>
    <description>Measuring changes in SF-36 survey responses which assesses general health status.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>MAS-PAP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep; followed by positive airway pressure (PAP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAP-MAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Positive airway pressure (PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open; followed by mandibular advancement splints (MAS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positive Airway Pressure (PAP)</intervention_name>
    <description>Continuous or auto-adjusting positive airway pressure (i.e. CPAP, APAP, and described here as PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open</description>
    <arm_group_label>MAS-PAP</arm_group_label>
    <arm_group_label>PAP-MAS</arm_group_label>
    <other_name>CPAP, auto-CPAP, APAP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mandibular Advancement Splints (MAS)</intervention_name>
    <description>Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep</description>
    <arm_group_label>MAS-PAP</arm_group_label>
    <arm_group_label>PAP-MAS</arm_group_label>
    <other_name>Oral appliance</other_name>
    <other_name>Mandibular advancement devices</other_name>
    <other_name>Somnodent device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        You may be able to participate in this study if:&#xD;
&#xD;
          -  You are naïve to treatment (never used CPAP or oral appliance, nor had surgery for&#xD;
             sleep apnea);&#xD;
&#xD;
          -  You are between 19-75 years old;&#xD;
&#xD;
          -  You have a Body Mass Index (BMI) ≤ 35;&#xD;
&#xD;
          -  You have enough teeth (at least 8 per arch) for MAS;&#xD;
&#xD;
          -  You have:&#xD;
&#xD;
               -  an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 50 documented with&#xD;
                  polysomnography in the last 2 years; ***OR***&#xD;
&#xD;
               -  a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented&#xD;
                  with level III portable sleep test; ***OR***&#xD;
&#xD;
               -  an Oxygen Desaturation Index (ODI) ≥ 10; and&#xD;
&#xD;
          -  You have had a sleep test within the past 2 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        You may not be able to participate in this study if:&#xD;
&#xD;
          -  You have extensive periodontal disease with significant tooth mobility (disease around&#xD;
             your teeth);&#xD;
&#xD;
          -  You are unable to protrude the jaw (unable to extend your jaw);&#xD;
&#xD;
          -  You have a lack of a sufficient vertical opening to accommodate an appliance;&#xD;
&#xD;
          -  You have uncontrolled congestive heart failure (defined as a prior clinical diagnosis,&#xD;
             an ejection cutoff of 40% or a clinical sign in the opinion of a primary care&#xD;
             physician or cardiologist) that makes it unsafe for you to participate in the trial in&#xD;
             the opinion of the investigators;&#xD;
&#xD;
          -  You have coronary artery disease unless stable for at least 6 months and considered by&#xD;
             the investigators to have a stable disease;&#xD;
&#xD;
          -  You have a history of angina (chest pain when your heart does not get enough blood),&#xD;
             myocardial infarction (heart attack) or stroke;&#xD;
&#xD;
          -  You have a history of major depressive disorder (such as bipolar disorder) along with&#xD;
             current moderate or severe disease;&#xD;
&#xD;
          -  You have cancer unless in remission (decreasing signs of your cancer being present)&#xD;
             for more than 1 year;&#xD;
&#xD;
          -  You have known renal (kidney) failure with need for dialysis;&#xD;
&#xD;
          -  You are pregnant (if a female participant becomes pregnant during the trial, she will&#xD;
             be withdrawn from the study);&#xD;
&#xD;
          -  You have had a near miss or prior automobile accident due to sleepiness within the&#xD;
             past 12 months; and/or&#xD;
&#xD;
          -  At nighttime, 30% of the night is at ≤ 90% oxygen saturation levels.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernanda R Almeida, DDS, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Montreal / Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laval University / Université Laval</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Almeida FR, Mulgrew A, Ayas N, Tsuda H, Lowe AA, Fox N, Harrison S, Fleetham JA. Mandibular advancement splint as short-term alternative treatment in patients with obstructive sleep apnea already effectively treated with continuous positive airway pressure. J Clin Sleep Med. 2013 Apr 15;9(4):319-24. doi: 10.5664/jcsm.2576.</citation>
    <PMID>23585745</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Fernanda Almeida</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>CPAP</keyword>
  <keyword>Oral Appliance</keyword>
  <keyword>Mandibular Advancement Splints</keyword>
  <keyword>Preference</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/NCT02242617
org study id: H14-01215
secondary id: RN325361
nct id: NCT02242617
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians.
      It is the cause of significant healthcare costs with increased morbidity and mortality. The
      two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic
      Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both
      therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance,
      cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness
      and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use.
      Until now, studies have used self-reported adherence data on MAS versus objective adherence
      on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is
      counterbalanced by the superior adherence relative to PAP, resulting in a similar
      effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS and
      could be used to prove this hypothesis and allow a new and complete comparison of
      effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's
      objective adherence and long-term symptomatic improvement would provide vital information to
      doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will
      receive both PAP and MAS in a random sequence. This innovative study lead by two experienced
      new investigators, and a research team of multidisciplinary experts, will assess objective
      adherence, treatment efficacy, patient preference, sleepiness and quality of life of each
      treatment used at home for 1 month per treatment. After this, patients will be able to go
      back and forth between both treatments during an additional 6-month period. The results of
      this study will be used by healthcare policy makers as well as clinicians who need to be part
      of the treatment plan decision for the many Canadians who suffer from sleep apnea.
The primary aim of this study is to assess objective adherence to treatment, for PAP and MAS,
      and to evaluate if there will be similar effectiveness (efficacy+adherence) between PAP and
      MAS treatment for patients with mild to severe OSA. The secondary aim is to assess if patient
      preference does correlate to the final treatment adherence. An exploratory aim is to assess
      if the strategy of patients having both treatments available to use interchangeably could
      further improve treatment adherence, sleepiness, quality of life and fatigue. Having a better
      insight into patient adherence will improve the cost-effectiveness of treatment and will
      improve the health and quality of life for many Canadians who suffer from sleep apnea.

      The proposed trial is a randomized open-label, two-treatment, two-period cross-over trial
      followed by an observational trial. Sixty OSA patients (10≤AHI≤50) will receive both PAP and
      MAS. As a recent innovation, we have adherence monitors for MAS that can give a new and
      comprehensive comparative analysis of the effectiveness between MAS and PAP. In the
      randomized trial phase the two treatments will be used separately for 1 month each (after
      treatment adaptation/titration of 1-2 months for each device). Treatment efficacy and daily
      treatment use data will be assessed together with changes in symptoms (quality of life,
      sleepiness and fatigue). Patient initial preference will be determined by using a patient
      decision aid. This will be followed by the observational trial phase, where all patients will
      have access to both interventions at home for 6 months and be allowed to choose on a daily
      basis the intervention to use. The intervention duration of 6 months is to allow for a
      sustained response in long-term adherence and to observe changes in quality of life.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objectively measured adherence (hours/night and nights/week of intervention use).
time frame: At 1 month in the MAS treatment arm
description: Measuring objective adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
measure: Objectively measured adherence (hours/night and nights/week of intervention use).
time frame: At 1 month in CPAP treatment arm
description: Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
measure: Objectively measured adherence (hours/night and nights/week of intervention use).
time frame: At 1 month of using both treatments interchangeably.
description: Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
measure: Objectively measured adherence (hours/night and nights/week of intervention use).
time frame: At 6 months of using both treatments interchangeably
description: Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
measure: Apnea-hypopnea index
time frame: At baseline
description: Measuring apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) responses
time frame: At baseline
description: Measuring Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
measure: Epworth Sleepiness Scale (ESS) questionnaire responses.
time frame: At baseline
description: Measuring responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.
measure: Chalder fatigue scale questionnaire responses
time frame: At baseline
description: Measuring responses to the Chalder fatigue scale which assesses fatigue in the present state.
measure: SF-36 survey responses
time frame: At baseline
description: Measuring SF-36 survey responses which assesses general health status.
measure: Apnea-hypopnea index
time frame: At 1 month in MAS treatment arm
description: Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)
measure: Apnea-hypopnea index
time frame: At 1 month in CPAP treatment arm
description: Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) responses.
time frame: At 1 month in MAS treatment arm
description: Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) responses.
time frame: At 1 month of using both treatments interchangeably
description: Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) responses
time frame: At 6 months of using both treatments interchangeably
description: Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) responses.
time frame: At 1 month in CPAP treatment arm
description: Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
measure: Epworth Sleepiness Scale (ESS) questionnaire responses.
time frame: At 1 month in MAS treatment arm
description: Measuring changes in Epworth Sleepiness Scale (ESS) Questionnaire responses to compare daytime sleepiness.
measure: Epworth Sleepiness Scale (ESS) questionnaire responses.
time frame: At 1 month in CPAP treatment arm.
description: Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness
measure: Epworth Sleepiness Scale (ESS) questionnaire responses
time frame: At 1 month of using both treatments interchangeably
description: Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.
measure: Epworth Sleepiness Scale (ESS) questionnaire responses.
time frame: At 6 months of using both treatments interchangeably.
description: Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.
measure: Chalder fatigue scale questionnaire responses
time frame: At 1 month in MAS treatment arm
description: Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
measure: Chalder fatigue scale questionnaire responses
time frame: At 1 month in CPAP treatment arm
description: Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
measure: Chalder fatigue scale questionnaire responses
time frame: At 1 month of using both treatments interchangeably
description: Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
measure: Chalder fatigue scale questionnaire responses
time frame: At 6 months of using both treatments interchangeably.
description: Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
measure: SF-36 survey responses.
time frame: At 1 month in MAS treatment arm
description: Measuring changes in SF-36 survey responses which assesses general health status.
measure: SF-36 survey responses.
time frame: At 1 month in CPAP treatment arm.
description: Measuring changes in SF-36 survey responses which assesses general health status.
measure: SF-36 survey responses.
time frame: At 1 month of using both treatments interchangeably.
description: Measuring changes in SF-36 survey responses which assesses general health status.
measure: SF-36 survey responses.
time frame: At 6 months of using both treatments interchangeably.
description: Measuring changes in SF-36 survey responses which assesses general health status.
arm group label: MAS-PAP
arm group type: Active Comparator
description: Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep; followed by positive airway pressure (PAP)
arm group label: PAP-MAS
arm group type: Active Comparator
description: Positive airway pressure (PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open; followed by mandibular advancement splints (MAS)
intervention type: Device
intervention name: Positive Airway Pressure (PAP)
description: Continuous or auto-adjusting positive airway pressure (i.e. CPAP, APAP, and described here as PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open
arm group label: MAS-PAP
arm group label: PAP-MAS
other name: CPAP, auto-CPAP, APAP
intervention type: Device
intervention name: Mandibular Advancement Splints (MAS)
description: Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep
arm group label: MAS-PAP
arm group label: PAP-MAS
other name: Oral appliance
other name: Mandibular advancement devices
other name: Somnodent device
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: Fernanda R Almeida, DDS, MSc, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
facility: 
country: Canada
citation: Almeida FR, Mulgrew A, Ayas N, Tsuda H, Lowe AA, Fox N, Harrison S, Fleetham JA. Mandibular advancement splint as short-term alternative treatment in patients with obstructive sleep apnea already effectively treated with continuous positive airway pressure. J Clin Sleep Med. 2013 Apr 15;9(4):319-24. doi: 10.5664/jcsm.2576.
PMID: 23585745
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Fernanda Almeida
investigator title: Principle Investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive