<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/NCT03262519</url>
  </required_header>
  <id_info>
    <org_study_id>170683</org_study_id>
    <nct_id>NCT03262519</nct_id>
  </id_info>
  <brief_title>The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making</brief_title>
  <official_title>The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</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>
      Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored&#xD;
      neurocognitive consequences. The investigators will study OSA patients before and after&#xD;
      treatment to understand how OSA changes decision making abilities, and whether treatment can&#xD;
      reverse such cognitive changes. These results could provide deeper insight into how OSA&#xD;
      affects decision making either temporarily or permanently, and provide another rationale or&#xD;
      motivation for treatment of OSA in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that OSA will lead to (H1) more reward-seeking and lower&#xD;
      payoffs in the Iowa Gambling task, replicating previous findings; (H2) greater discounting of&#xD;
      future rewards in financial choices; and (H3) these effects would dissipate when OSA is&#xD;
      successfully treated.&#xD;
&#xD;
      In order to test these hypotheses, the investigators will perform cognitive tests (Iowa&#xD;
      gambling; intertemporal choice; other measures) in 100 patients about to undergo sleep&#xD;
      testing. It is expected that of these 100 patients, some will have no sleep apnea; some will&#xD;
      have sleep apnea and will be successfully treated; and that some will have sleep apnea but&#xD;
      will not be successfully treated by the time of repeat testing. The investigators will repeat&#xD;
      testing using the same instruments 2 months later.&#xD;
&#xD;
      Thus the investigators will be able to compare whether OSA patients differ from control at&#xD;
      baseline (t1), and whether OSA patients' performance will improve after treatment at t2,&#xD;
      compared to the control at t2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Iowa Gambling Task</measure>
    <time_frame>2 months (baseline, 2 months later)</time_frame>
    <description>The Iowa Gambling Task is a psychological task thought to simulate real-life decision making. It is completed on a computer and takes about 10 minutes. It is widely used in research on cognition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Reflection Test (CRT)</measure>
    <time_frame>2 months (baseline, 2 months later)</time_frame>
    <description>The Cognitive Reflection Test (CRT) is a task designed to measure a person's tendency to override an incorrect &quot;gut&quot; response and engage in further reflection to find a correct answer. It takes about 3 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intertemporal Choice</measure>
    <time_frame>2 months (baseline, 2 months later)</time_frame>
    <description>Intertemporal choice is the study of how people make choices about what and how much to do at various points in time, when choices at one time influence the possibilities available at other points in time. These choices are influenced by the relative value people assign to two or more payoffs at different points in time. It takes about 3 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Balloon Analogue Risk Task (BART)</measure>
    <time_frame>2 months (baseline, 2 months later)</time_frame>
    <description>The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss. It takes less than 2 minute to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Epworth Sleepiness Score</measure>
    <time_frame>2 months (baseline, 2 months later)</time_frame>
    <description>An 11 item questionnaire that is commonly used to assess for excessive daytime sleepiness (range 0-24 points, &gt;10 considered excessively sleepy).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">96</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Patients at UCSD Sleep Medicine Clinic</arm_group_label>
    <description>Patients referred for sleep testing (either home sleep testing or in-lab full polysomnography) will be approached for participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Computer based neurocognitive testing</intervention_name>
    <description>Iowa Gambling Task, The Balloon Task, Intertemporal choices task, Cognitive Reflection Test, Physiological and self-reported measures of OSA/sleep related symptoms, General health and physiological measures.</description>
    <arm_group_label>Patients at UCSD Sleep Medicine Clinic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects aged 18-75 referred to the UCSD Sleep clinic for either home or in-laboratory&#xD;
        testing will be considered for inclusion in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects aged 18-75 referred to the UCSD Sleep clinic for either home or in-laboratory&#xD;
        testing will be considered for inclusion in the study. Inclusion will not depend on gender,&#xD;
        race or ethnicity, as per the following:&#xD;
&#xD;
          1. 100 participants will be enrolled at the UCSD Sleep Clinic at Chancellor Park.&#xD;
&#xD;
          2. Ages 18-75&#xD;
&#xD;
          3. Gender: Men and woman&#xD;
&#xD;
          4. Ethnic background: All&#xD;
&#xD;
          5. Health Status: to the UCSD Sleep clinic for either home or in-laboratory testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing CPAP treatment for OSA&#xD;
&#xD;
          2. Inability to use a tablet device (e.g. no reading glasses, or unfamiliar with&#xD;
             devices).&#xD;
&#xD;
          3. Severe cardiopulmonary disorder that requires treatment with supplemental oxygen&#xD;
             therapy.&#xD;
&#xD;
          4. Inability to speak English fluently, as some of the questionnaires/tests are only&#xD;
             validated in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 4, 2022</last_update_submitted>
  <last_update_submitted_qc>March 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Robert L. Owens</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03262519
org study id: 170683
nct id: NCT03262519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) is an extremely common disease with inadequately explored
      neurocognitive consequences. The investigators will study OSA patients before and after
      treatment to understand how OSA changes decision making abilities, and whether treatment can
      reverse such cognitive changes. These results could provide deeper insight into how OSA
      affects decision making either temporarily or permanently, and provide another rationale or
      motivation for treatment of OSA in adults.
The investigators hypothesize that OSA will lead to (H1) more reward-seeking and lower
      payoffs in the Iowa Gambling task, replicating previous findings; (H2) greater discounting of
      future rewards in financial choices; and (H3) these effects would dissipate when OSA is
      successfully treated.

      In order to test these hypotheses, the investigators will perform cognitive tests (Iowa
      gambling; intertemporal choice; other measures) in 100 patients about to undergo sleep
      testing. It is expected that of these 100 patients, some will have no sleep apnea; some will
      have sleep apnea and will be successfully treated; and that some will have sleep apnea but
      will not be successfully treated by the time of repeat testing. The investigators will repeat
      testing using the same instruments 2 months later.

      Thus the investigators will be able to compare whether OSA patients differ from control at
      baseline (t1), and whether OSA patients' performance will improve after treatment at t2,
      compared to the control at t2.
observational model: Cohort
time perspective: Prospective
measure: Change in Iowa Gambling Task
time frame: 2 months (baseline, 2 months later)
description: The Iowa Gambling Task is a psychological task thought to simulate real-life decision making. It is completed on a computer and takes about 10 minutes. It is widely used in research on cognition.
measure: Change in Cognitive Reflection Test (CRT)
time frame: 2 months (baseline, 2 months later)
description: The Cognitive Reflection Test (CRT) is a task designed to measure a person's tendency to override an incorrect "gut" response and engage in further reflection to find a correct answer. It takes about 3 minutes to complete.
measure: Change in Intertemporal Choice
time frame: 2 months (baseline, 2 months later)
description: Intertemporal choice is the study of how people make choices about what and how much to do at various points in time, when choices at one time influence the possibilities available at other points in time. These choices are influenced by the relative value people assign to two or more payoffs at different points in time. It takes about 3 minutes to complete.
measure: Change in Balloon Analogue Risk Task (BART)
time frame: 2 months (baseline, 2 months later)
description: The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss. It takes less than 2 minute to complete.
measure: Change in Epworth Sleepiness Score
time frame: 2 months (baseline, 2 months later)
description: An 11 item questionnaire that is commonly used to assess for excessive daytime sleepiness (range 0-24 points, >10 considered excessively sleepy).
arm group label: Patients at UCSD Sleep Medicine Clinic
description: Patients referred for sleep testing (either home sleep testing or in-lab full polysomnography) will be approached for participation.
intervention type: Diagnostic Test
intervention name: Computer based neurocognitive testing
description: Iowa Gambling Task, The Balloon Task, Intertemporal choices task, Cognitive Reflection Test, Physiological and self-reported measures of OSA/sleep related symptoms, General health and physiological measures.
arm group label: Patients at UCSD Sleep Medicine Clinic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Robert L. Owens
investigator title: Assistant Clinical Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided