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Effect of Activity on Sleep of Cognitively-Impaired Veterans
This study has been completed.
First Received: March 14, 2001   Last Updated: January 30, 2009   History of Changes
Sponsors and Collaborators: Department of Veterans Affairs
Central Arkansas Veterans Healthcare System
University of Arkansas
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013182
  Purpose

Sleep-activity rhythm disturbance is a prevalent, disabling symptom in cognitively-impaired (CI) elders. Their nocturnal sleep is light and inefficient with frequent awakenings. Multiple short daytime napping episodes interfere with daytime activity and functioning. Daytime disruptive behaviors, such as pacing, hitting, and cursing are related significantly to sleep-activity rhythm disturbance. Medical treatment for sleep and behavior disturbances with benzodiazepines or antipsychotic medications has proven minimally effective and has serious side effects such as impairments in cognition, memory, coordination, and balance, tolerance and severe rebound insomnia, and tardive dyskinesia.


Condition Intervention
Alzheimer's Disease
Sleep Disorders
Behavioral: social activity

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Sleep Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: Effect of Activity on Sleep of Cognitively-Impaired Veterans

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 90
Study Completion Date: June 2001
Arms Assigned Interventions
1 Behavioral: social activity

Detailed Description:

Background:

Sleep-activity rhythm disturbance is a prevalent, disabling symptom in cognitively-impaired (CI) elders. Their nocturnal sleep is light and inefficient with frequent awakenings. Multiple short daytime napping episodes interfere with daytime activity and functioning. Daytime disruptive behaviors, such as pacing, hitting, and cursing are related significantly to sleep-activity rhythm disturbance. Medical treatment for sleep and behavior disturbances with benzodiazepines or antipsychotic medications has proven minimally effective and has serious side effects such as impairments in cognition, memory, coordination, and balance, tolerance and severe rebound insomnia, and tardive dyskinesia.

Objectives:

The degree of daytime sleepiness in elders may reflect a reduction in the purposive physical, cognitive, and affective activities that previously sustained daytime alertness and promoted psychological well-being. For some institutionalized elders, living in a physically, cognitively, and emotionally understimulating setting may induce excessive napping during the day with a subsequent adverse impact on circadian sleep-wake patterns.

Concrete, reality-based activities may counter napping by keeping residents with dementia involved in the world around them and helping them meet psychological, physical, and social needs. Our pilot study with five nursing home residents demonstrated that activities timed to occur during usual naptime and tailored to residents� interests and their remaining abilities improved nocturnal sleep. Our other research has shown that engaging residents in meaningful activity improved their psychological well-being and decreased certain types of disruptive behaviors.

Methods:

We tested the effect of an Individualized Activity Intervention timed to occur when the resident usually napped in the daytime on nocturnal sleep as measured by actigraphy in CI nursing home residents. Examples of individualized activities include objects for tactile and visual stimulation, arts and crafts, and games. We also tested the effect of the intervention on psychological well-being and disruptive behavior, and measured its cost. After the collection of baseline sleep, disruptive behavior, and psychological well-being data for five days, residents were randomly assigned to the Individualized Activity Intervention or to a usual care control condition for 21 days. On days 17-21, the research assistant repeated the outcome measures.

Status:

Secondary data analysis on psychological well-being, disruptive behavior, and cost of the intervention is in progress.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants must have been a resident in the nursing home for at least two weeks, must be at least 55 years old, have a diagnosis of dementia, a Mini-Mental State Examination Score of <24, sleep less than 85% of the night, and nap at least 30 minutes during the day.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013182

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
University of Arkansas
Investigators
Principal Investigator: Kathleen C. Richards, PhD RN Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Richards, Kathleen - Principal Investigator )
Study ID Numbers: NRM 95-184
Study First Received: March 14, 2001
Last Updated: January 30, 2009
ClinicalTrials.gov Identifier: NCT00013182     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Neurologic Manifestations
Central Nervous System Diseases
Sleep Disorders
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Neurologic Manifestations
Central Nervous System Diseases
Sleep Disorders
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 06, 2009