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Home > "E" Clinical Trials Conditions > Effect of Activity on Sleep of Cognitively-Impaired Veterans  Effect of Activity on Sleep of Cognitively-Impaired Veterans
Effect of Activity on Sleep of Cognitively-Impaired Veterans
For Condition: Alzheimer's Disease,Sleep Disorders
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service,Central Arkansas Veterans Healthcare System,University of Arkansas
Synopsis: Sleep-activity rhythm disturbance is a highly prevalent, disabling symptom in cognitively-impaired (CI) elders. Their nocturnal sleep is light and inefficient with frequent arousals and awakenings. Multiple short daytime napping episodes interfere with daytime activity and functioning. Furthermore, daytime disruptive behaviors, such as pacing, hitting, and cursing, are related significantly to sleep-activity rhythm disturbance. Interventions for sleep-activity rhythm disturbance consist primarily of pharmacological agents. Medical treatment for sleep and behavior disturbances with benzodiazepines or antipsychotic medications has proven only minimally effective and has serious side effects such as impairments in cognition, memory, coordination, and balance; tolerance and severe rebound insomnia; and tardive dyskinesia. Feasible, cost-effective nonpharmacological interventions that address the precipitating causes of sleep-activity rhythm disturbance require testing. Activity is proposed as one nonpharmacological intervention for nocturnal sleep disturbance, but no one has tested its efficacy. 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 important 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. Therefore, we are testing the effect of an Individualized Activity Intervention timed to occur when the resident usually naps in the daytime on nocturnal sleep as measured by actigraphy in 90 CI nursing home residents who demonstrate sleep-activity rhythm disturbance. Examples of individualized activities include objects for tactile and visual stimulation, arts and crafts, and games. We also are testing the effect of the intervention on psychological well-being and disruptive behavior. After the collection of baseline sleep, disruptive behavior, and psychological well-being data for five days, residents are randomly assigned to the Individualized Activity Intervention or to a control condition for 21 days. On days 17-21, the research assistant repeats the outcome measures.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 55 Years/
Genders: Male
Protocol Entry 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.
Total Enrollment: 90
Location and Contact Information:
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72114-1706
United States
Additional Information:
Study ID Numbers: NRM 95-184;
Study Start Date: July 1997
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013182
Other Sleep Disorders Studies:
1. Gene-Environment Interactions in Alzheimer's Disease
2. PET Scan of Brain Metabolism in Relation to Age and Disease
3. Brain Study of Patients with Frontal Lobe Dementia and Parkinsonian Disorders
4. Diagnosis and Natural History Study of Patients with Neurological Conditions
5. Nefiracetam in the Treatment of Alzheimer's Disease
Related Studies:
Other Sleep Disorders Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
Effect of Activity on Sleep of Cognitively-Impaired Veterans
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