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临床试验/NCT02967185
NCT02967185已完成不适用

Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

University of Missouri-Columbia0 个研究点目标入组 62 人开始时间: 2005年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
主要终点
Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up

研究概览

简要总结

The proposed study will examine changes in older insomniacs' cognitive functioning following behavioral treatment for insomnia using a combination of two methods. A traditional repeated measures design will be used to look at group level differences based on performance on a neuropsychological battery administered prior to, immediately after, and 3 months after completing a 4 week behavioral treatment program for insomnia. This data will be analyzed using standard repeated measures analytic techniques. A time-series design will also be used to look at within-subject differences based on a brief cognitive battery that will be self-administered on a daily basis. Data from this daily battery will be examined using intraindividual variability modeling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age >65 years
  • Community dwelling
  • Available for duration of study
  • Insomnia according to American Sleep Disorders Association (1990) criteria: (a) >30 minutes of unwanted awake time, 3 nights per week for at least 6 months and (b) Daytime dysfunction (reported mood, cognitive, social, or occupational impairment)

排除标准

  • Age less than 65
  • history of primary sleep disorder (e.g., sleep apnea, narcolepsy)
  • history of stroke
  • major medical illness known to contribute to sleep problems in last 12 months
  • cognitive impairment that interferes with ability to understand treatment (score <23 on Mini-Mental State Examination)

研究组 & 干预措施

Brief Behavioral Therapy for Insomnia

Experimental

Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis.

干预措施: Brief Behavioral Therapy for Insomnia (Behavioral)

Waitlist Control

No Intervention

Participants in this group will receive no intervention, but will complete the same set of assessments as those in the Experimental Group. They will be given the option of receiving the behavioral treatment program at no charge.

结局指标

主要结局

Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up

时间窗: from baseline to follow-up, approximately 1 year

Participants will complete a daily sleep dairies throughout the study period. They will report their bedtime, waketime, sleep onset latency, and wake time after sleep onset. Total sleep time and total wake time will be calculated from the diaries.

次要结局

  • Change in performance on the Mini-Mental Status Exam(from baseline to follow-up, approximately 1 year)
  • Change in performance on the Trails A & B (Reitan, 1958)(from baseline to follow-up, approximately 1 year)
  • Change in performance on the Boston Naming Test (BNT)(from baseline to follow-up, approximately 1 year)
  • Change in performance on the Wechsler Memory Scale-3, Logical Memory & Visual Reproduction subtests (WMS-3) Tremblay, 2002)(from baseline to follow-up, approximately 1 year)
  • Change in performance on the Controlled Oral Word Association(from baseline to follow-up, approximately 1 year)
  • Change in performance on the California Verbal Learning Test (CVLT, CVLT-II)(from baseline to follow-up, approximately 1 year)
  • Change in actigraphy-assessed sleep variability from baseline to follow-up(from baseline to follow-up, approximately 1 year)
  • Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley & Tremblay, 2002)(from baseline to follow-up, approximately 1 year)
  • Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol(from baseline to follow-up, approximately 1 year)

研究者

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

Christina McCrae

Professor

University of Missouri-Columbia

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