Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-10 @ 4:17 PM
Study NCT ID:
NCT03353558
Status:
UNKNOWN
Last Update Posted:
2017-11-28
First Post:
2017-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Assessment in CML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-26', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of subjective and objective sleep disturbances among patients with CML', 'timeFrame': '1 week of sleep parameters measuring', 'description': 'The prevalence will be compared to the Control group in the study and to the prevalnce of sleep disturbances reported in other studies.'}], 'secondaryOutcomes': [{'measure': 'Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group.', 'timeFrame': '1 week', 'description': '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'}, {'measure': 'Correlation of objective sleep disturbances with the CML patients characteristics.', 'timeFrame': '1 week', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Disorder', 'Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring the assessment week they will be asked to fill in a short "sleep diary" to be correlated with the objective Actigraph results.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThere 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.\n\nthe study will be with the collaboration of Professor Iris Haymov, sleep researcher from the Max Stern Academic College of Emek Yezreel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CML patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CML patients\n* Without known sleep disturbances that are not related to the disease\n\nExclusion Criteria:\n\n* Malignancy other than CML\n* Known sleep disturbances\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03353558', 'acronym': 'CML-SLEEP', 'briefTitle': 'Sleep Assessment in CML', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'OBJECTIVE AND SUBJECTIVE ASSESSMENT OF SLEEP QUALITY IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA', 'orgStudyIdInfo': {'id': 'EMC 141-17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group (CML group)', 'description': 'This group will be CML patients. In this group each participant will be asked to wear a watch "Actigraph" for one week.\n\nHe will be asked to fill the appropriate questionnaires, and a daily sleep diary.', 'interventionNames': ['Device: Actigraph']}, {'label': 'Control Group', 'description': 'The control group will be non-CML patients, also without any known malignancy or known sleep disturbances.\n\nThey will be asked to wear the watch "Actigraph" for one week, and to fill the appropriate questionnaires and a daily sleep diary.', 'interventionNames': ['Device: Actigraph']}], 'interventions': [{'name': 'Actigraph', 'type': 'DEVICE', 'otherNames': ['Actiwatch (different name for the same device)'], 'description': 'The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.', 'armGroupLabels': ['Control Group', 'Study Group (CML group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aviv A Ariel, Doctor', 'role': 'CONTACT', 'email': 'Ariel_av@clalit.org.il', 'phone': '+972542666036'}, {'name': 'Baher A Krayem, Doctor', 'role': 'CONTACT', 'email': 'krayem.baher@gmail.com', 'phone': '+972533361059'}], 'overallOfficials': [{'name': 'Aviv A Ariel, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of hematology department'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be available as from December 2018. The data will be available all the time.', 'ipdSharing': 'YES', 'description': 'All date can be shared with other researchers.', 'accessCriteria': 'Anyone can access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Max Stern Academic College Of Emek Yezreel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of hematology', 'investigatorFullName': 'Ariel Aviv', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}