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临床试验/NCT04899089
NCT04899089已完成不适用

Cognitive Training in Mild Cognitive Impairment: Effects on Sleep, Cognition and Arousal

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Objective Sleep-Watchpat

研究概览

简要总结

Older adults (60+ years of age) who meet criteria for mild cognitive impairment and insomnia will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and arousal at baseline, and post-intervention. For cognitive training, participants will be provided with login information to access the computerized training, and will complete 8 weeks (45 mins 3x/week) of cognitive training. For trivia training, participants will receive weekly emails that contain trivia assignments that they will complete for 8 weeks (45 mins 3x/week). We will evaluate short-term (i.e., post-training) effects of the two training conditions on subjective anxiety, sleep, arousal, and subjective and objective cognition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • 60+ yrs of age
  • meet criteria for mild cognitive impairment
  • no neurological or psychiatric illness or dementia
  • non-gamers (<2 hour of video/brain training games/week over last 2 yrs)
  • proficient in English (reading and writing)
  • meet clinical dx criteria for Insomnia (e.g., insomnia complaints for 6+ months, complaints occur despite adequate opportunity and circumstances for sleep, consist of one of the following: difficulty falling asleep, staying asleep, or waking up too early, and daytime dysfunction due to insomnia)

排除标准

  • unable to provide informed consent
  • unable to undergo randomization
  • other sleep disorder (e.g., sleep apnea, restless legs syndrome)
  • severe untreated psychiatric comorbidity
  • psychotropic or other medications that alter sleep (unless stabilized for 6 months)
  • uncorrected visual/auditory impairments
  • participation in nonpharmacological tx for sleep/fatigue/mood/cognition outside the current study

结局指标

主要结局

Objective Sleep-Watchpat

时间窗: Up to 10 weeks

Single night objective sleep recording via a wrist worn device.

Objective Cognition - Computerized Cognitive Tasks

时间窗: Up to 10 weeks

Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed, attention, memory).

Subjective Cognitive Self-Efficacy. - Cognitive Failures Questionnaire

时间窗: Up to 10 weeks

A 25 item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.

Subjective Behavioral Sleep- Electronic Daily Sleep Diaries

时间窗: Up to 10 days

Electronic Daily Sleep Diaries. Online diaries completed each morning (\~5 mins) during the study. Diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.

Subjective Behavioral Sleep- Insomnia Severity Index

时间窗: Up to 10 weeks

Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.

次要结局

  • Circadian Rhythm- Morningness-Eveningness Questionnaire(Up to 10 weeks)
  • Physical Activity - International Physical Activity Questionnaire(Up to 10 weeks)
  • Personality - Big Five Inventory(Baseline)
  • Anxiety - State-Trait Anxiety Inventory(Up to 10 weeks)
  • Game Engagement Questionnaire(Up to 10 weeks)
  • Physiological Arousal- Heart Rate Variability(Impact of game related experience will be measured at baseline)
  • Game-related experience- Sessions and duration played(Up to 10 weeks)
  • Perceived Stress- Perceived Stress Scale Subjective Arousal- Perceived Stress Scale(Up to 10 weeks)
  • Mood-Depression-Beck Depression Inventory-II(Up to 10 weeks)
  • Alcohol Use - Alcohol Use Disorder Test(Baseline)
  • Subjective Arousal- Arousal Predisposition Scale(Up to 10 weeks)
  • Computer Proficiency- Computer Proficiency Questionnaire(Baseline)

研究者

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

Ashley Curtis

Assistant Professor of Psychiatry

University of Missouri-Columbia

研究点 (2)

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