Sleep Assessment in CML (CML-SLEEP)

OBJECTIVE AND SUBJECTIVE ASSESSMENT OF SLEEP QUALITY IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Disorder; Chronic Myeloid Leukemia
• Intervention / Treatment: Device: Actigraph

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Aviv A Ariel, Doctor; Phone Number: +972542666036; Email: Ariel_av@clalit.org.il
• Study Contact Backup: Name: Baher A Krayem, Doctor; Phone Number: +972533361059; Email: krayem.baher@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

CML patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.	Device: 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 Names: Actiwatch (different name for the same device)
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.	Device: 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 Names: Actiwatch (different name for the same device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of subjective and objective sleep disturbances among patients with CML	The prevalence will be compared to the Control group in the study and to the prevalnce of sleep disturbances reported in other studies.	1 week of sleep parameters measuring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group.	The investigators will correlate between the subjective and the objective results. the investigators will seek correlation between the anxiety, quality of life and depression questionnaires and the subjective reports of sleep disturbances and whether these reports supported objectively or not	1 week
Correlation of objective sleep disturbances with the CML patients characteristics.	The characteristics that will be used will be: the duration of the disease, the clinical response to therapy, the type of therapy that the patients receive.	1 week

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Collaborators: The Max Stern Academic College Of Emek Yezreel
• Investigators: Principal Investigator: Aviv A Ariel, Doctor, Head of hematology department

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia, Myeloid; Sleep Wake Disorders; Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: EMC 141-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All date can be shared with other researchers.
• IPD Sharing Time Frame: The data will be available as from December 2018. The data will be available all the time.
• IPD Sharing Access Criteria: Anyone can access
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No