Effects of Bright Light to Improve Agitation and Sleep Disorders in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 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
- 否
入选标准
- •Age over 60 years
- •Patient hospitalized in geriatric care immediately or long-term care,
- •Patients with probable Alzheimer's disease according to NINCDS-ADRDA
- •Stage of moderate to severe Alzheimer's disease (defined as MMSE between 2 and 21).
- •Patients with agitation rated 4 or more per item agitation / aggression of the behavior rating scale Neuropsychiatric Inventory-nurse,
- •Patient free from acute disease.
- •Patient with sleep apnea evaluation scale ONSI (Observation-based nocturnal Sleep Inventory) negative
- •Affiliation to a social security scheme
- •Signature of consent by the patient himself or the trusted person or legal representative for patients under guardianship
排除标准
- •Patients may leave the ward within 4 weeks
- •Patient refusing to participate in the study
- •Patient with a trusted person and / or legal representative which refuses participation in the study.
- •Patients suffering from retinopathy (DMLA, proliferative diabetic retinopathy) or blindness for whatever reason, lack of crystalline (or aphakia). (These conditions will be systematically sought by an ophthalmologic consultation if the patient has not had in the year before inclusion.)
- •Patient receiving photosensitizing drug imipramine, lithium, tetracycline, hydrochlorothiazide, phenothiazine.
- •Patients suffering from porphyria.
- •Patient with known sleep apnea syndrome. (A specific test for the detection of sleep apnea will be checked prior to the inclusion of patients. This is the test ONSI, validated in elderly demented persons, and allowing screened for sleep apnea in patients with a sensitivity of 91%. ONSI positive test will be an exclusion criteria of the study.)
- •Patient with known REM sleep behavior disorder
- •Patients with clinical criteria of mental confusion as diagnosing clinician.
- •Patient with obvious pathology may itself cause behavior disorders: psychosis, manic-depressive illness, a condition with acute or chronic pain. (In these cases, the inclusion of the patient may be reviewed after returning to a stable clinical condition for at least 3 weeks.)
- •Unbalanced psychotropic treatment subject to dose modifications in the previous 4 weeks (patients receiving one or more psychotropic stable dose for at least 3 weeks may be included).
研究组 & 干预措施
Luxtherapy
Luxtherapy exposition
干预措施: Luxtherapy (Other)
Not luxtherapy
Not luxtherapy exposition
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)