Intraindividual Variability in Sleep and Cognitive Performance in Older Adults (REST)

November 15, 2016 updated by: Christina McCrae, University of Missouri-Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Waitlist Control
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?

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
Time Frame: 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.
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
Time Frame: from baseline to follow-up, approximately 1 year
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
Time Frame: from baseline to follow-up, approximately 1 year
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
Time Frame: from baseline to follow-up, approximately 1 year
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)
Time Frame: from baseline to follow-up, approximately 1 year
Trails A & B (Reitan, 1958) was administered
from baseline to follow-up, approximately 1 year
Change in performance on the Controlled Oral Word Association
Time Frame: from baseline to follow-up, approximately 1 year
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)
Time Frame: from baseline to follow-up, approximately 1 year
Boston Naming Test (BNT)
from baseline to follow-up, approximately 1 year
Change in performance on the California Verbal Learning Test (CVLT, CVLT-II)
Time Frame: from baseline to follow-up, approximately 1 year
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)
Time Frame: from baseline to follow-up, approximately 1 year
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)
Time Frame: from baseline to follow-up, approximately 1 year
from baseline to follow-up, approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 221286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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