Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013182
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Effect of Activity on Sleep of Cognitively-Impaired Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Activity on Sleep of Cognitively-Impaired Veterans
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None