Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Behavioral: Brief Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Behavioral Therapy for Insomnia<br>Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. | Behavioral: Brief Behavioral Therapy for Insomnia<br>* Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. Treatment components will include education about aging and sleep. It will also include instruction in techniques designed to: (a) promote good sleep habits, (b) restrict the use of the bed and bedroom to sleep and sleep-conducive activities, (c) modify bed and wake times to better match the participants sleep needs, and (d) promote relaxation. Daily home practice of these techniques will be encouraged. Participants will maintain logs of their home practice sessions and will continue to record their daily sleep habits throughout treatment.<br>|
| No Intervention: Waitlist Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up | 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. | from baseline to follow-up, approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in actigraphy-assessed sleep variability from baseline to follow-up | Participants wore an Actiwatch-L (ACTL) (Mini Mitter Co., Inc.) on their non-dominant wrists continuously throughout the study. The sensor of the ACTL is sampled 32 times per second and records peak values for each second. These peak values are then summed into 30-second activity counts. These activity counts are downloaded to a personal computer and analyzed using Actiware-Sleep v. 3.3, which uses a validated algorithm to identify periods of as sleep or wake. Total sleep time and total wake time will be computed. | from baseline to follow-up, approximately 1 year | 
| Change in performance on the Mini-Mental Status Exam | Mini-Mental Status Exam (MMSE) (Folstein, Folstein, & McHugh, 1975) | from baseline to follow-up, approximately 1 year | 
| Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol | Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol (subtests) [WAIS-3] | from baseline to follow-up, approximately 1 year | 
| Change in performance on the Trails A & B (Reitan, 1958) | Trails A & B (Reitan, 1958) was administered | from baseline to follow-up, approximately 1 year | 
| Change in performance on the Controlled Oral Word Association | Controlled Oral Word Association (COWA) (Benton & Hamsher, 1983) | from baseline to follow-up, approximately 1 year | 
| Change in performance on the Boston Naming Test (BNT) | Boston Naming Test (BNT) | from baseline to follow-up, approximately 1 year | 
| Change in performance on the California Verbal Learning Test (CVLT, CVLT-II) | California Verbal Learning Test (CVLT, CVLT-II) (Delis, Kramer, Kaplan, & Ober, 1987) | 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 the Wechsler Memory Scale-3, Logical Memory & Visual Reproduction subtests (WMS-3) Tremblay, 2002) |  | from baseline to follow-up, approximately 1 year |