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

University of Washington

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders; Alzheimer Disease

Treatments: Behavioral: Walking Program; Behavioral: Combined Education, Walking and Light Exposure Program; Behavioral: Light Exposure Program; Behavioral: Routine Medical Care with Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00183378

R01MH072736 (U.S. NIH Grant/Contract)

DATR A4-GPS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 4 patient groups

1

Active Comparator group

Description:

Routine medical care with education: therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support.

Treatment:

Behavioral: Routine Medical Care with Education

2

Active Comparator group

Description:

Walking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant.

Treatment:

Behavioral: Walking Program

3

Active Comparator group

Description:

Light exposure: 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.

Treatment:

Behavioral: Light Exposure Program

4

Active Comparator group

Description:

Combination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.

Treatment:

Behavioral: Combined Education, Walking and Light Exposure Program