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

January 12, 2012 updated by: Sue McCurry, University of Washington

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
Behavioral: Routine 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.
Active Comparator: 2
Walking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant.
Behavioral: Walking Program
The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
Active Comparator: 3
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.
Behavioral: Light 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.
Active Comparator: 4
Combination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
Behavioral: Combined 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient total wake time (actigraphy)
Time Frame: Measured 3 times over 6 months
Measured 3 times over 6 months
Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory)
Time Frame: Measured 3 times over 6 months
Measured 3 times over 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional patient actigraphy outcomes
Time Frame: Measured 3 times over 6 months
Measured 3 times over 6 months
Patient daytime sleepiness, behavioral problems, and residential status
Time Frame: Measured 3 times over 6 months
Measured 3 times over 6 months
Caregiver sleep
Time Frame: Measured 3 times over 6 months
Measured 3 times over 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Susan M. McCurry, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH072736 (U.S. NIH Grant/Contract)
  • DATR A4-GPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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