Clinical trial NCT03353558: Sleep Assessment in CML
Official title: OBJECTIVE AND SUBJECTIVE ASSESSMENT OF SLEEP QUALITY IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disorder
Chronic Myeloid Leukemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: The Max Stern Academic College Of Emek Yezreel
First posted: 2017-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CML patients

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Prevalence of subjective and objective sleep disturbances among patients with CML
timeFrame: 1 week of sleep parameters measuring
Secondary outcomes:
measure: Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group.
timeFrame: 1 week
measure: Correlation of objective sleep disturbances with the CML patients characteristics.
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Head of hematology department
name: Aviv A Ariel, Doctor
role: PRINCIPAL_INVESTIGATOR
References: