Effects of Computerized Cognitive Brain Training on Sleep, Arousal, and Daytime Functioning in Older Adults With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire
研究概览
简要总结
The purpose of this research is to look at the effects of computerized cognitive training on sleep, mental abilities (cognition), and other aspects of daytime functioning, such as mood, and arousal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60+ yrs of age.
- •No neurological or psychiatric illness, dementia, or loss of consciousness > 5 mins.
- •Nongamers (i.e. <1 hour of video/cognitive training games per week over last 2 years)
- •Proficient in English (reading and writing).
- •Meet clinical diagnosis for Insomnia.
- •Insomnia complaints for 6+ months.
- •Complaints occur despite adequate opportunity and circumstances for sleep.
- •Consist of 1+ of the following: difficulty falling asleep, staying asleep, or waking up too early
- •Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia.
排除标准
- •Unable to provide informed consent.
- •Unable to undergo randomization.
- •Cognitive impairments (i.e. mild cognitive impairment, dementia)
- •Other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder)
- •Severe untreated psychiatric comorbidity that renders randomization unethical
- •Using psychotropic or other medications (e.g., beta-blockers) that alter sleep
- •Uncorrected visual/auditory impairments
- •Participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.
结局指标
主要结局
Subjective Cognitive Self-Efficacy- Cognitive Failures Questionnaire
时间窗: Up to 15 weeks
A 25-item scale measuring subjective cognition. Participants rate on a scale of 0 (never) to 4 (very often) how often they experience cognitive mistakes and errors in daily tasks.
Objective Cognition- NIH Toolbox Cognitive Battery
时间窗: Up to 15 weeks
20-min computerized battery completed in single sitting on iPad.Domains tested include processing speed and attention, visuospatial ability and memory, verbal learning and memory, and executive functioning and working memory.
次要结局
- Physiological Arousal- Heart Rate Variability(Up to 15 weeks)
- Mood- Beck Depression Inventory (II)(Up to 15 weeks)
- Objective Behavioral Sleep - Actigraphy(Up to 15 weeks)
- Circadian Rhythm - Morningness-Eveningness Questionnaire(Up to 15 weeks)
- Subjective Arousal-Global Cognitive Arousal-Perceived Stress Scale(Up to 15 weeks)
- Mood- State-Trait Anxiety Inventory(Up to 15 weeks)
- Subjective Arousal- Pre-sleep Arousal Scale(Up to 15 weeks)
- Subjective Behavioral Sleep- Electronic Daily Sleep Diaries(Up to 15 weeks)
- Subjective Behavioral Sleep- Insomnia Severity Index(Up to 15 weeks.)
- Objective Sleep-PSG(Up to 15 weeks)
- Subjective Arousal- Arousal Predisposition Scale(Up to 15 weeks)
- Game-related experience(Up to 6 weeks)
- Alcohol Use- Alcohol Use Disorder Test(Baseline)
研究者
Ashley Curtis
Assistant Professor
University of Missouri-Columbia