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临床试验/NCT00183378
NCT00183378已完成不适用

Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease

University of Washington1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2005年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
1
主要终点
Patient total wake time (actigraphy)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

1

Active Comparator

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.

干预措施: Routine Medical Care with Education (Behavioral)

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.

干预措施: Walking Program (Behavioral)

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 bright light is one hour.

干预措施: Light Exposure Program (Behavioral)

4

Active Comparator

Combination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.

干预措施: Combined Education, Walking and Light Exposure Program (Behavioral)

结局指标

主要结局

Patient total wake time (actigraphy)

时间窗: Measured 3 times over 6 months

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

时间窗: Measured 3 times over 6 months

次要结局

  • Additional patient actigraphy outcomes(Measured 3 times over 6 months)
  • Patient daytime sleepiness, behavioral problems, and residential status(Measured 3 times over 6 months)
  • Caregiver sleep(Measured 3 times over 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sue McCurry

Research Professor

University of Washington

研究点 (1)

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