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Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
This study is currently recruiting participants.
Study NCT00183378   Information provided by National Institute of Mental Health (NIMH)
First Received: September 13, 2005   Last Updated: March 23, 2009   History of Changes

September 13, 2005
March 23, 2009
September 2005
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Actigraph measures of patient total wake time at night; measured at Months 2 and 6
  • Caregiver reports of patient behavioral disturbances at night; measured at Months 2 and 6
Complete list of historical versions of study NCT00183378 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Caregiver sleep; measured at Months 2 and 6
  • Patient daytime sleepiness, behavioral problems, and residential status; measured at Months 2 and 6
  • Patient and caregiver mood and health; measured at Months 2 and 6
 
Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
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).

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • 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
  • 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.
  • 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.
  • 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.
  • Active Comparator: Combination: the therapist does all three of the treatments: routine medical care with education, walking, and light exposure.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
136
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact: Amy Moore, MS 206-616-5550 amoore@u.washington.edu
United States
 
NCT00183378
Susan M. McCurry, PhD, University of Washington
R01 MH072736, DATR A4-GPS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Susan M. McCurry, PhD University of Washington
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP