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临床试验/NCT03262519
NCT03262519Unknown不适用

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

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年7月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
Change in Iowa Gambling Task

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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:
  • 100 participants will be enrolled at the UCSD Sleep Clinic at Chancellor Park.
  • Gender: Men and woman
  • Ethnic background: All
  • Health Status: to the UCSD Sleep clinic for either home or in-laboratory testing

排除标准

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

结局指标

主要结局

Change in Iowa Gambling Task

时间窗: 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.

次要结局

  • Change in Intertemporal Choice(2 months (baseline, 2 months later))
  • Change in Cognitive Reflection Test (CRT)(2 months (baseline, 2 months later))
  • Change in Balloon Analogue Risk Task (BART)(2 months (baseline, 2 months later))
  • Change in Epworth Sleepiness Score(2 months (baseline, 2 months later))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert L. Owens

Assistant Clinical Professor

University of California, San Diego

研究点 (1)

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