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临床试验/NCT02686190
NCT02686190已完成不适用

Effects of Bright Light to Improve Agitation and Sleep Disorders in Patients With Alzheimer's Disease

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
2
主要终点
score agitation / aggression scale NPI-nurse

研究概览

简要总结

Background: Management of patients with Alzheimer's disease associated with behavioral disturbances is difficult especially in those with agitation/aggression and insomnia and nighttime behaviors. No treatment has shown any efficacy to control these disturbances and psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects.

Objective: Assess the effect of bright light therapy on behavioral disturbances of patients with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and nighttime behaviours.

Study design: Multicenter non pharmacological intervention trial, controlled, randomized, open, two-arm design : control group and intervention group.

Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards.

Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric inventory, nurse scale (NPI-nurse).

Treatments: Intervention group: patients will participate in a program of bright light therapy realised during a one-hour sessions of occupational therapy,. These sessions will be realised for groups of 6 patients and will be done every week day, at late morning, for 4 consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light. Patients of control group will participate in a program of occupational therapy of same duration and rhythm, realised in standard light conditions (about 300 lux).

Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after the beginning of the programs. Assessment will comprise ; NPI-nurse scale and Cohen-Mansfield scale for behaviour disturbances, wrist actimetry for sleep and nighttime behaviours (total sleep length, nocturnal wake episodes and nocturnal motor agitation).

Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale. Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield, total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry.

Statistics: Changes in agitation/aggression scores od the two groups will be compared by Mann and Whitney test.

Expected results and perspectives; If bright light exposure is efficient, professional caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological approach to improve behaviour and sleep of these patients. This study might contribute to better define the place of a non invasive and promising technique, wrist actigraphy, to assess sleep and behaviour disturbances in psychogeriatric patients

详细描述

Our hypothesis is that bright light can help improve behavior and sleep in patients with Alzheimer's disease with agitation type of behavior disorders. This hypothesis has been built on the notion that morning exposure to bright light can reduce the synchronization of circadian rhythms observed in patients with this disease, and the preliminary study data on low numbers and supporting this hypothesis.

OBJECTIVES Primary objectives: To study the effect of treatment with bright light to improve patient behavior disorders Alzheimer's disease, including its effect on agitation / aggression (score obtained in item agitation / aggression of NPI scale-nurse).

Secondary objective: (1) To study the effect of treatment with bright light to improve patient behavior disorders Alzheimer's disease, including its effect on sleep disorders (score obtained in item nocturnal sleep-behavior NPI -nurse, scale score of Cohen-Mansfield) ; (2) To study the effect of treatment with bright light treatment on cognitive function in patients with Alzheimer's disease (MMSE score of the scale). (3)To examine the interest of the wrist actigraphy to assess motor behavior and sleep in Alzheimer's disease.

RESEARCH DESIGN The primary endpoint is the change over time of the score obtained in item agitation / aggression of the NPI-nurse level.

The secondary endpoints are:

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

score agitation / aggression scale NPI-nurse

时间窗: Baseline, 2 weeks and 4 weeks

Change over time of the score obtained in item agitation-aggression of the NPI-level nurse.

次要结局

  • score agitation-aggression scale NPI-nurse(Baseline, 2 weeks and 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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