An Observational Epidemiological Study on Evaluation of Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 925
- 主要终点
- Sleep disturbances measures by Scores on the Pittsburgh Sleep Quality Index (PSQI) Scale
研究概览
简要总结
The purpose of this study is to evaluate sleep quality in patients with mild to moderate Alzheimer's disease treated with anticholinesterase drugs in clinical practice.
详细描述
This is an epidemiological (the study of health-related states or events in specific populations) study of patients with mild to moderate Alzheimer's who have been treated previously with anticholinesterase drugs (class of drugs that act in the central nervous system) up to a maximum of fifteen days. The data for each patient will be recorded on two occasions; first at a baseline visit and then at a follow-up visit at 3 months. At the baseline visit, after the patient or his/her legal representative has given written informed consent, each participating neurologist will use the study questionnaire to collect patient sociodemographic characteristics (characteristics such as age, years of education, race, sex, religion, birthplace, income, occupation, geographic location, among others), medical history and diagnosis of Alzheimer's disease. The neurologist will also record treatment for Alzheimer's disease and concomitant hypnotic medications (simultaneous use of medications that induce sleep) and evaluate the patient using two scales: the Pittsburgh Sleep Quality Index (PSQI) to record sleep disturbances and the Epworth Sleepiness Scale to determine the level of daytime sleepiness. Alzheimer treatment and concomitant hypnotic medications will be recorded again at the follow-up visit. Patient sleep quality using the PSQI and daytime sleepiness using the Epworth scale will also be evaluated again at this visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with a recent diagnosis of possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria) within a maximum of 60 days before the baseline visit.
- •Patients with mild or moderate Alzheimer's disease, defined by a Mini-Mental State Exam (MMSE) score between 11 and
- •Patients whose caregivers are sufficiently informed of the patients' state and if possible live with the patient.
- •Patients who are capable of attending a second clinic visit with their accompanying person 3 months later, based on the clinical practice of the investigator.
- •Patients and/or legal representatives who have given and signed written informed consent.
排除标准
- •Patients who have psychotic manifestations.
- •Patients who have clinically significant sleep disorder (sleep apnea syndrome, restless leg syndrome).
- •Patients treated with memantine.
- •Patients and/or legal representatives who refuse to give written informed consent to participate in the study.
结局指标
主要结局
Sleep disturbances measures by Scores on the Pittsburgh Sleep Quality Index (PSQI) Scale
时间窗: Up to 3 months
The PSQI consists of 19 self-rated questions which assesses sleep quality and disturbances over 1-month time interval. The 19 questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and the frequency and severity of specific sleep-related problems. These 19 items are grouped into seven components scores, each weighted equally on a 0-3 scale. The seven components scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.
次要结局
- The Level of Daytime Sleepiness determined by the Scores on the Epworth Sleepiness Scale(Up to 3 months)