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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sue McCurry, University of Washington
ClinicalTrials.gov Identifier:
NCT00183378
First received: September 13, 2005
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Behavioral: Walking Program
Behavioral: Light Exposure Program
Behavioral: Combined Education, Walking and Light Exposure Program
Behavioral: Routine Medical Care with Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Patient total wake time (actigraphy) [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
  • Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory) [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional patient actigraphy outcomes [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
  • Patient daytime sleepiness, behavioral problems, and residential status [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
  • Caregiver sleep [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: September 2005
Study Completion Date: March 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183378

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Susan M. McCurry, PhD University of Washington
  More Information

Publications:
Responsible Party: Sue McCurry, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00183378     History of Changes
Other Study ID Numbers: R01 MH072736, R01MH072736, DATR A4-GPS
Study First Received: September 13, 2005
Last Updated: January 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Alzheimer's Disease
Insomnia
Sleep Problems
Elderly
Caregivers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014