Alzheimer Disease Clinical Trial
Official title:
Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer's disease (AD).
Nocturnal disturbances, such as getting out of bed repeatedly, having hallucinations,
talking or singing in bed, and waking up confused are common among patients with AD. Such
nocturnal disturbances are associated with increased physical and psychological morbidity in
both AD patients and their caregivers and are a major risk factor for patient
institutionalization. Nonpharmacologic treatments for these disturbances are needed. This
study will assign AD patients to one of four different treatments to determine which is most
effective in reducing nocturnal disturbances.
This study will last 6 months. Participants will be randomly assigned to a walking program,
a light exposure program, a "NITE-AD" program, combining the walking and light exposure
programs, or routine AD care with nocturnal disturbance education. Walking program
participants will have three 1-hour visits with a therapist over an 8-week period. The
therapist and the participant will set an initial daily walking goal and develop a plan for
gradually increasing the participants' walking to 30 minutes/day, to be increased at a
participant-selected pace. Pedometers will be given to participants to monitor daily
activity. The therapist will also discuss exercise safety and will review ways to prevent
muscle soreness. Light program participants will also have three 1-hour visits with a
therapist over 8 weeks. The therapist will develop a daily, caregiver-supervised light
exposure plan requiring participants to sit in front of a light box for 1 hour every day.
NITE-AD program participants will have six 1-hour visits with a therapist over 8 weeks;
their visits will include setting up both walking and the light exposure routines.
Participants assigned to education will receive information about about sleep in aging and
dementia, but no assistance setting up walking or light exposure plans.
Participants will be assessed at study entry and at Months 2 (post-test) and 6. The sleep
patterns of both the patients and the caregivers will be measured. Caregiver reports of
patients' night-time behavioral disturbances and readings from an actigraph, a small
electronic device worn by participants that records and reports their levels of activity at
night, will be used to estimate sleep. The study will also collect data on patient and
caregiver mood, stress, and behavior. A follow-up visit will occur 6 months after study
completion; at the follow-up visit, the same outcome measures will be collected as at
baseline and post-test. Participants will receive 3 biannual phone follow-ups (12, 18, and
24 months) to assess patient residential status and caregiver reports of patient and
caregiver sleep.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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