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Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2009
First Received: September 13, 2005   Last Updated: March 23, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183378
  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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Actigraph measures [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
  • Caregiver reports of patient behavioral disturbances at night [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caregiver sleep [ 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 ]

Estimated Enrollment: 136
Study Start Date: September 2005
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Routine medicare care with education: therapist provides information about the nature of sleep changes in people with Alzheimer's disease and information about treatments for insomnia.
Behavioral: Routine Medical Care with Education
The therapist provides information to the caregiver about the nature of sleep changes in people with Alzheimer's disease and information about treatments for insomnia. Participants are free to use whatever medical services they wish during study participation.
2: Active Comparator
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 daily walking routine of 30 minutes for the study participant.
3: Active Comparator
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 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 light is one hour.
4: Active Comparator
Combination: the therapist does all three of the treatments: routine medical care with education, walking, and light exposure.
Behavioral: Combined Education, Walking and Light Exposure Program
The therapist provides a combination of education, walking, and light exposure treatments.

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 both the walking and the light exposure program visits. Participants assigned to receive education about night disturbances associated with Alzheimer's disease will not receive any treatment in the study, but will continue their usual treatment outside of the study.

Participants will be assessed at study entry and at Months 2 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 assess participants. A follow-up visit will occur 6 months after study completion; at the follow-up visit, participants and their caregivers will be interviewed about the participants' nocturnal disturbances.

  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 Alzheimer's Disease
  • Have at least two sleep disturbances each 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183378

Contacts
Contact: Amy Moore, MS 206-616-5550 amoore@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Amy Moore, MS     206-616-5550     amoore@u.washington.edu    
Principal Investigator: Susan M. McCurry, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Susan M. McCurry, PhD University of Washington
  More Information

Publications:
Responsible Party: University of Washington ( Susan M. McCurry, PhD )
Study ID Numbers: R01 MH072736, DATR A4-GPS
Study First Received: September 13, 2005
Last Updated: March 23, 2009
ClinicalTrials.gov Identifier: NCT00183378     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Alzheimer's Disease
Insomnia
Sleep Problems
Elderly
Caregivers

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Sleep Disorders
Dyssomnias
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Sleep Disorders, Intrinsic
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Delirium

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Dyssomnias
Sleep Disorders
Brain Diseases
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on September 10, 2009