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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03262519
• Other study ID #: 170683
• Status: Active, not recruiting
• Start date: July 20, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)