Clinical trial NCT02967185: Intraindividual Variability in Sleep and Cognitive Performance in Older Adults
Official title: Intraindividual Variability in Sleep and Cognitive Performance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia Chronic
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2016-11-18
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up
timeFrame: from baseline to follow-up, approximately 1 year
Secondary outcomes:
measure: Change in actigraphy-assessed sleep variability from baseline to follow-up
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Mini-Mental Status Exam
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Trails A & B (Reitan, 1958)
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Controlled Oral Word Association
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Boston Naming Test (BNT)
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the California Verbal Learning Test (CVLT, CVLT-II)
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley & Tremblay, 2002)
timeFrame: from baseline to follow-up, approximately 1 year
measure: Change in performance on the Wechsler Memory Scale-3, Logical Memory & Visual Reproduction subtests (WMS-3) Tremblay, 2002)
timeFrame: from baseline to follow-up, approximately 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Christina McCrae, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.
citation: McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Berry RB, McCoy KM, Marsiske M. Effects of Brief Behavioral Treatment for Insomnia on Daily Associations between Self-Reported Sleep and Objective Cognitive Performance in Older Adults. Behav Sleep Med. 2020 Sep-Oct;18(5):577-588. doi: 10.1080/15402002.2019.1632201. Epub 2019 Jun 15.
citation: Curtis AF, Williams JM, McCoy KJM, McCrae CS. Chronic Pain, Sleep, and Cognition in Older Adults With Insomnia: A Daily Multilevel Analysis. J Clin Sleep Med. 2018 Oct 15;14(10):1765-1772. doi: 10.5664/jcsm.7392.
citation: McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Chan WS, Berry RB, McCoy KJM, Marsiske M. Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes. Sleep Med. 2018 Nov;51:153-166. doi: 10.1016/j.sleep.2018.05.018. Epub 2018 Jun 2.
citation: Chan WS, Williams J, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Berry RB, McCoy KJM, McCrae CS. Night-to-Night Sleep Variability in Older Adults With Chronic Insomnia: Mediators and Moderators in a Randomized Controlled Trial of Brief Behavioral Therapy (BBT-I). J Clin Sleep Med. 2017 Nov 15;13(11):1243-1254. doi: 10.5664/jcsm.6790.