Sleep Assessment in CML
关键词
抽象
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.
The sleep watch that will be used is called Actigraph/Actiwatch and it is FDA approved device, this device will help the investigators assess and observe the objective sleep parameters like length of sleep, time to fall asleep, number of awakenings at night.
There will be no intervention in the study, the results will not alter the treatment the patients receive. But if some patients will be found to have a severe depression or anxiety they will be referred to psychiatric consult.
the study will be with the collaboration of Professor Iris Haymov, sleep researcher from the Max Stern Academic College of Emek Yezreel.
日期
| 最后验证: | 10/31/2017 |
| 首次提交: | 11/15/2017 |
| 提交的预估入学人数: | 11/19/2017 |
| 首次发布: | 11/26/2017 |
| 上次提交的更新: | 11/25/2017 |
| 最近更新发布: | 11/27/2017 |
| 实际学习开始日期: | 11/30/2017 |
| 预计主要完成日期: | 04/30/2018 |
| 预计完成日期: | 11/30/2018 |
状况或疾病
干预/治疗
Device: Actigraph
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Study Group (CML group) This group will be CML patients. In this group each participant will be asked to wear a watch "Actigraph" for one week.
He will be asked to fill the appropriate questionnaires, and a daily sleep diary. | |
| Control Group The control group will be non-CML patients, also without any known malignancy or known sleep disturbances.
They will be asked to wear the watch "Actigraph" for one week, and to fill the appropriate questionnaires and a daily sleep diary. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - CML patients - Without known sleep disturbances that are not related to the disease Exclusion Criteria: - Malignancy other than CML - Known sleep disturbances - Pregnant women |
结果
主要结果指标
1. Prevalence of subjective and objective sleep disturbances among patients with CML [1 week of sleep parameters measuring]
次要成果指标
1. Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group. [1 week]
2. Correlation of objective sleep disturbances with the CML patients characteristics. [1 week]
