Skip to main content
OpenTrials
Completed

NCT Number: NCT00183378

Using Behavioral Programs to Treat Sleep Problems in Individuals With 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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking program

Behavioral

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

Light Exposure Program

Behavioral

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.

Combined Education, Walking and Light Exposure Program

Behavioral

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.

Routine Medical Care with Education

Behavioral

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.

Primary outcomes

  1. Patient total wake time (actigraphy)

    Time frame: Measured 3 times over 6 months

  2. Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory)

    Time frame: Measured 3 times over 6 months

Secondary outcomes

  1. Additional patient actigraphy outcomes

    Time frame: Measured 3 times over 6 months

  2. Patient daytime sleepiness, behavioral problems, and residential status

    Time frame: Measured 3 times over 6 months

  3. Caregiver sleep

    Time frame: Measured 3 times over 6 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Sep 16, 2005
Registry last updated
Jan 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.