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OpenTrials
Completed

NCT Number: NCT02967185

Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

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.

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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brief Behavioral Therapy for Insomnia

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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]

  4. 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

  5. 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)

  6. Change in performance on the Boston Naming Test (BNT)

    Time frame: from baseline to follow-up, approximately 1 year

    Boston Naming Test (BNT)

  7. 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)

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • University of Florida

Registry information

Acronym: REST

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 18, 2016
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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