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Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease

Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00183378
Enrollment
132
Registered
2005-09-16
Start date
2005-09-30
Completion date
2011-03-31
Last updated
2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Sleep Initiation and Maintenance Disorders

Keywords

Alzheimer's Disease, Insomnia, Sleep Problems, Elderly, Caregivers

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALWalking Program

The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.

BEHAVIORALLight Exposure Program

The therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour.

BEHAVIORALCombined Education, Walking and Light Exposure Program

The therapist provides a combination of education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.

BEHAVIORALRoutine Medical Care with Education

The therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Participants are free to use whatever medical services they wish during study participation.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for Alzheimer's Disease Patients: * Diagnosis of probable or possible Alzheimer's Disease * Have at least two sleep disturbances, occurring 3 or more times per week * Reside in a residential home with a family member caregiver * Able to walk without assistance

Exclusion criteria

for Alzheimer's Disease Patients: * Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder * Blindness * Current use of photosensitizing medication Inclusion Criteria for Family Caregiver: * Currently caring for a family member with Alzheimer's disease

Design outcomes

Primary

MeasureTime frame
Patient total wake time (actigraphy)Measured 3 times over 6 months
Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory)Measured 3 times over 6 months

Secondary

MeasureTime frame
Additional patient actigraphy outcomesMeasured 3 times over 6 months
Patient daytime sleepiness, behavioral problems, and residential statusMeasured 3 times over 6 months
Caregiver sleepMeasured 3 times over 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026