Effect of Activity on Sleep of Cognitively-Impaired Veterans - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 14, 2001

Last Updated Date

January 30, 2009

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00013182 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Effect of Activity on Sleep of Cognitively-Impaired Veterans

Official Title ^†

Effect of Activity on Sleep of Cognitively-Impaired Veterans

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:

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Condition ^†

Alzheimer's Disease
Sleep Disorders

Intervention ^†

Behavioral: social activity

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2001

Primary Completion Date

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:

Gender

Male

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00013182

Responsible Party

Richards, Kathleen - Principal Investigator, Department of Veterans Affairs

Secondary IDs ^††

Study Sponsor ^†

Department of Veterans Affairs

Collaborators ^††

Central Arkansas Veterans Healthcare System
University of Arkansas

Investigators ^†

Principal Investigator:

Kathleen C. Richards, PhD RN

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

Information Provided By

Department of Veterans Affairs

Verification Date

January 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.