An interventional study of social activity in Alzheimer's Disease and Sleep Disorders, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to male participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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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:
Behavioral: social activity
This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs