OBJECTIVE AND SUBJECTIVE ASSESSMENT OF SLEEP QUALITY IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Prevalence of subjective and objective sleep disturbances among patients with CML
研究概览
简要总结
Patients with CML report on fatigue, and many of them report on sleep disturbances. The investigators wish to objectively assess the patient's sleep using a sleep "wrist watch" (Actigraph) , and correlate data with their perception of sleep quality. A matched participants group will serve as control. the Control group is defined as participants not having CML or any other malignancy and without any known sleep disturbances.
详细描述
The investigators will contact the CML patients cohort (about 50) and ask them to join the study. Those consenting will be briefed on the use of an Actigraph wrist device, which the patients should wear for a week. In addition, patients will fill quality of life, depression and anxiety questionnaires.
During the assessment week they will be asked to fill in a short "sleep diary" to be correlated with the objective Actigraph results.
The investigators will analyze objective data and compare to the subjective report of patient's sleep and compare these results with a matched cohort of the control participants. The investigators will analyze the quality of life, anxiety and depression scores also.
The main objective of the study is to try and find a correlation between CML and sleep disturbances, several previous studies found sleep disturbances in reported questionnaires, but the sleep parameters were never studied objectively. Also most of the studies concentrated on the fatigue as the main symptom, in our study the investigators will focus on sleep quality and quantity as a primary symptom.
The quality of life questionnaire will be WHOQOL-BREF questionnaire. The anxiety questionnaire will be Hamilton Anxiety Rating Scale. The depression questionnaire will be Beck Depression Inventory.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CML patients
- •Without known sleep disturbances that are not related to the disease
排除标准
- •Malignancy other than CML
- •Known sleep disturbances
- •Pregnant women
结局指标
主要结局
Prevalence of subjective and objective sleep disturbances among patients with CML
时间窗: 1 week of sleep parameters measuring
The prevalence will be compared to the Control group in the study and to the prevalnce of sleep disturbances reported in other studies.
次要结局
- Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group.(1 week)
- Correlation of objective sleep disturbances with the CML patients characteristics.(1 week)
研究者
Ariel Aviv
Head of hematology
HaEmek Medical Center, Israel