Effect of Activity on Sleep of Cognitively-Impaired Veterans
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|ClinicalTrials.gov Identifier: NCT00013182|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Sleep Disorders||Behavioral: social activity||Not Applicable|
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.
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.
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.
Secondary data analysis on psychological well-being, disruptive behavior, and cost of the intervention is in progress.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Activity on Sleep of Cognitively-Impaired Veterans|
|Actual Study Completion Date :||June 2001|
|Arm 1||Behavioral: social activity|
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): NCT00013182
|United States, Arkansas|
|Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|
|No. Little Rock, Arkansas, United States, 72114-1706|
|Principal Investigator:||Kathleen C. Richards, PhD RN||Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|