Sleep-activity rhythm disturbance is a highly prevalent, disabling symptom in cognitively-impaired (CI) elders. Their nocturnal sleep is light and inefficient with frequent arousals and awakenings. Multiple short daytime napping episodes interfere with daytime activity and functioning. Furthermore, daytime disruptive behaviors, such as pacing, hitting, and cursing, are related significantly to sleep-activity rhythm disturbance. Interventions for sleep-activity rhythm disturbance consist primarily of pharmacological agents. Medical treatment for sleep and behavior disturbances with benzodiazepines or antipsychotic medications has proven only minimally effective and has serious side effects such as impairments in cognition, memory, coordination, and balance; tolerance and severe rebound insomnia; and tardive dyskinesia. Feasible, cost-effective nonpharmacological interventions that address the precipitating causes of sleep-activity rhythm disturbance require testing. Activity is proposed as one nonpharmacological intervention for nocturnal sleep disturbance, but no one has tested its efficacy. 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 important 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. Therefore, we are testing the effect of an Individualized Activity Intervention timed to occur when the resident usually naps in the daytime on nocturnal sleep as measured by actigraphy in 90 CI nursing home residents who demonstrate sleep-activity rhythm disturbance. Examples of individualized activities include objects for tactile and visual stimulation, arts and crafts, and games. We also are testing the effect of the intervention on psychological well-being and disruptive behavior. After the collection of baseline sleep, disruptive behavior, and psychological well-being data for five days, residents are randomly assigned to the Individualized Activity Intervention or to a control condition for 21 days. On days 17-21, the research assistant repeats the outcome measures.

Condition	Treatment or Intervention
Alzheimer's Disease Sleep Disorders	Behavior: social activity

Further Study Details: 

Expected Total Enrollment:  90

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Male

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.

Arkansas
      Central Arkansas Veterans Healthcare System, No Little Rock,  Arkansas,  72114-1706,  United States

Study ID Numbers:  NRM 95-184
Record last reviewed:  October 2000
Last Updated:  October 13, 2004
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00013182
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08