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The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making

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ClinicalTrials.gov Identifier: NCT03262519
Recruitment Status : Enrolling by invitation
First Posted : August 25, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Diagnostic Test: Computer based neurocognitive testing

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients at UCSD Sleep Medicine Clinic
Patients referred for sleep testing (either home sleep testing or in-lab full polysomnography) will be approached for participation.
Diagnostic Test: Computer based neurocognitive testing
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.




Primary Outcome Measures :
  1. Change in Iowa Gambling Task [ Time Frame: 2 months (baseline, 2 months later) ]
    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.


Secondary Outcome Measures :
  1. Change in Cognitive Reflection Test (CRT) [ Time Frame: 2 months (baseline, 2 months later) ]
    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.

  2. Change in Intertemporal Choice [ Time Frame: 2 months (baseline, 2 months later) ]
    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.

  3. Change in Balloon Analogue Risk Task (BART) [ Time Frame: 2 months (baseline, 2 months later) ]
    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.

  4. Change in Epworth Sleepiness Score [ Time Frame: 2 months (baseline, 2 months later) ]
    An 11 item questionnaire that is commonly used to assess for excessive daytime sleepiness (range 0-24 points, >10 considered excessively sleepy).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects aged 18-75 referred to the UCSD Sleep clinic for either home or in-laboratory testing will be considered for inclusion in the study.
Criteria

Inclusion Criteria:

Subjects aged 18-75 referred to the UCSD Sleep clinic for either home or in-laboratory testing will be considered for inclusion in the study. Inclusion will not depend on gender, race or ethnicity, as per the following:

  1. 100 participants will be enrolled at the UCSD Sleep Clinic at Chancellor Park.
  2. Ages 18-75
  3. Gender: Men and woman
  4. Ethnic background: All
  5. Health Status: to the UCSD Sleep clinic for either home or in-laboratory testing

Exclusion Criteria:

  1. Ongoing CPAP treatment for OSA
  2. Inability to use a tablet device (e.g. no reading glasses, or unfamiliar with devices).
  3. Severe cardiopulmonary disorder that requires treatment with supplemental oxygen therapy.
  4. Inability to speak English fluently, as some of the questionnaires/tests are only validated in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262519


Locations
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United States, California
University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: Robert L. Owens, Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03262519     History of Changes
Other Study ID Numbers: 170683
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases