Sleep Assessment in CML

NCT03353558 | Unknown FDA Device

• 1 other identifier: EMC 141-17
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Disorder; Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group.

  1 week

• Correlation of objective sleep disturbances with the CML patients characteristics.

  1 week

Study Arms (2)

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

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

Interventions

Actigraph DEVICE

The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.

Also known as: Actiwatch (different name for the same device)

Control Group; Study Group (CML group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CML patients

You may qualify if:

• CML patients
• Without known sleep disturbances that are not related to the disease

You may not qualify if:

• Malignancy other than CML
• Known sleep disturbances
• Pregnant women

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• The Max Stern Academic College Of Emek Yezreel: collaborator

MeSH Terms

Conditions

Sleep Wake Disorders; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Aviv A Ariel, Doctor

  Head of hematology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aviv A Ariel, Doctor

CONTACT

+972542666036; Ariel_av@clalit.org.il

Baher A Krayem, Doctor

CONTACT

+972533361059; krayem.baher@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of hematology

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 27, 2017
• Study Start: December 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available as from December 2018. The data will be available all the time.
• Access Criteria: Anyone can access