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Effect of Activity on Sleep of Cognitively-Impaired Veterans

Primary Purpose

Alzheimer's Disease, Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
social activity
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

Sites / Locations

  • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 14, 2001
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
Central Arkansas Veterans Healthcare System, University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00013182
Brief Title
Effect of Activity on Sleep of Cognitively-Impaired Veterans
Official Title
Effect of Activity on Sleep of Cognitively-Impaired Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Central Arkansas Veterans Healthcare System, University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Sleep Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
social activity

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen C. Richards, PhD RN
Organizational Affiliation
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16126650
Citation
Richards KC, Beck C, Shue VM, O'Sullivan PS. Demographic and sleep characteristics in cognitively impaired nursing home residents with and without severe sleep/wake pattern inefficiency. Issues Ment Health Nurs. 2005 Aug-Sep;26(7):751-69. doi: 10.1080/01612840591008339.
Results Reference
result
PubMed Identifier
16137280
Citation
Richards KC, Beck C, O'Sullivan PS, Shue VM. Effect of individualized social activity on sleep in nursing home residents with dementia. J Am Geriatr Soc. 2005 Sep;53(9):1510-7. doi: 10.1111/j.1532-5415.2005.53460.x.
Results Reference
result
PubMed Identifier
11820554
Citation
Richards KC, Sullivan SC, Phillips RL, Beck CK, Overton-McCoy AL. The effect of individualized activities on the sleep of nursing home residents who are cognitively impaired: a pilot study. J Gerontol Nurs. 2001 Sep;27(9):30-7. doi: 10.3928/0098-9134-20010901-07.
Results Reference
result
PubMed Identifier
12382454
Citation
Kolanowski AM, Richards KC, Sullivan SC. Derivation of an intervention for need-driven behavior. Activity preferences of persons with dementia. J Gerontol Nurs. 2002 Oct;28(10):12-5. doi: 10.3928/0098-9134-20021001-06. No abstract available.
Results Reference
result
Citation
Richards KC, Lambert C, Beck CK. Deriving interventions for challenging behaviors from the need-driven dementia-compromised behavior model. Alzheimer's care today. 2000 Oct 15; 1(4):62-76.
Results Reference
result

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Effect of Activity on Sleep of Cognitively-Impaired Veterans

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