Sleep Assessment in CML
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 10/31/2017 |
| First Submitted: | 11/15/2017 |
| Estimated Enrollment Submitted: | 11/19/2017 |
| First Posted: | 11/26/2017 |
| Last Update Submitted: | 11/25/2017 |
| Last Update Posted: | 11/27/2017 |
| Actual Study Start Date: | 11/30/2017 |
| Estimated Primary Completion Date: | 04/30/2018 |
| Estimated Study Completion Date: | 11/30/2018 |
Condition or disease
Intervention/treatment
Device: Actigraph
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Prevalence of subjective and objective sleep disturbances among patients with CML [1 week of sleep parameters measuring]
Secondary Outcome Measures
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]
