Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

Insomnia Chronic Clinical Trial

— REST  

Official title:

Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967185
• Other study ID #: 221286
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2016
• Last updated: November 15, 2016
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: November 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia Chronic

Intervention

Behavioral:
• Brief Behavioral Therapy for Insomnia
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	University of Florida

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in performance on the Boston Naming Test (BNT)	Boston Naming Test (BNT)	from baseline to follow-up, approximately 1 year	No
Secondary	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	No
Secondary	Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley & Tremblay, 2002)		from baseline to follow-up, approximately 1 year	No
Secondary	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	No