Sleep Assessment in CML

Sleep Disorder Clinical Trial

— CML-SLEEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03353558
• Other study ID #: EMC 141-17
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 26, 2017
• Start date: December 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: HaEmek Medical Center, Israel
• Contact: Aviv A Ariel, Doctor
• Phone: +972542666036
• Email: Ariel_av[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	The Max Stern Academic College Of Emek Yezreel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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