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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Iowa Gambling Task	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.	2 months (baseline, 2 months later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Reflection Test (CRT)	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 months (baseline, 2 months later)
Change in Intertemporal Choice	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.	2 months (baseline, 2 months later)
Change in Balloon Analogue Risk Task (BART)	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.	2 months (baseline, 2 months later)
Change in Epworth Sleepiness Score	An 11 item questionnaire that is commonly used to assess for excessive daytime sleepiness (range 0-24 points, >10 considered excessively sleepy).	2 months (baseline, 2 months later)

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (ACTUAL): August 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 170683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No