Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2017-12-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Actigraph
The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.
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.
Actigraph
The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.
Interventions
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Actigraph
The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Without known sleep disturbances that are not related to the disease
Exclusion Criteria
* Known sleep disturbances
* Pregnant women
18 Years
80 Years
ALL
Yes
Sponsors
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The Max Stern Academic College Of Emek Yezreel
OTHER
HaEmek Medical Center, Israel
OTHER
Responsible Party
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Ariel Aviv
Head of hematology
Principal Investigators
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Aviv A Ariel, Doctor
Role: PRINCIPAL_INVESTIGATOR
Head of hematology department
Central Contacts
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Other Identifiers
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EMC 141-17
Identifier Type: -
Identifier Source: org_study_id