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

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ClinicalTrials.gov Identifier: NCT02967185
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Christina McCrae, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Insomnia Chronic Behavioral: Brief Behavioral Therapy for Insomnia Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraindividual Variability in Sleep and Cognitive Performance in Older Adults
Study Start Date : May 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967185


Sponsors and Collaborators
University of Missouri-Columbia
University of Florida
Investigators
Principal Investigator: Christina McCrae, PhD University of Missouri-Columbia

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christina McCrae, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02967185     History of Changes
Other Study ID Numbers: 221286
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No