Sleep DisorderCML-SLEEPNCT03353558
Sleep Assessment in CML
An observational study of Sleep Disorder and Chronic Myeloid Leukemia, run by HaEmek Medical Center, Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Chronic Myeloid Leukemia
- What is being tested?
- Actigraph
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CML patients
Who may be able to join
- CML patients
- Without known sleep disturbances that are not related to the disease
Who cannot join
- Malignancy other than CML
- Known sleep disturbances
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Disorder, Chronic Myeloid Leukemia
- Being tested
- Actigraph
- Medical subject headings
- Sleep Wake Disorders, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphDevice
Also called Actiwatch (different name for the same device)
The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study startDec 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- The Max Stern Academic College Of Emek Yezreel
- Responsible party
- Principal investigator, Ariel Aviv, HaEmek Medical Center, Israel
- Investigators
- Aviv A Ariel, Doctor, Principal investigator, Head of hematology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353558
- Sponsor's protocol ID
- EMC 141-17
- Acronym
- CML-SLEEP
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All date can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBJECTIVE AND SUBJECTIVE ASSESSMENT OF SLEEP QUALITY IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA
- ClinicalTrials.gov ID
- NCT03353558
- Acronym / sponsor ID
- CML-SLEEP / EMC 141-17
- Conditions
- Sleep Disorder, Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- The Max Stern Academic College Of Emek Yezreel
- Study start
- Dec 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (CML group) | – | Device: ActigraphThis 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. |
| Control Group | – | Device: ActigraphThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CML patients
Key inclusion criteria (2 listed)
- CML patients
- Without known sleep disturbances that are not related to the disease
Key exclusion criteria (3 listed)
- Malignancy other than CML
- Known sleep disturbances
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphAlso: Actiwatch (different name for the same device)The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep. | Device | Control Group, Study Group (CML group) |
Primary outcome
Prevalence of subjective and objective sleep disturbances among patients with CML
Time frame: 1 week of sleep parameters measuring
The prevalence will be compared to the Control group in the study and to the prevalnce of sleep disturbances reported in other studies.
2 secondary outcomes
Comparison between the subjective sleep disturbances reported and the objective sleep disturbances measured in the CML patients group.
Time frame: 1 week
Correlation of objective sleep disturbances with the CML patients characteristics.
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Individual participant dataSharing planned: Yes. All date can be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aviv A Ariel, Doctor principal investigator
Head of hematology department
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Chronic Myeloid Leukemia, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviv A Ariel, Doctor (+972542666036, Ariel_av@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of subjective and objective sleep disturbances among patients with CML (time frame: 1 week of sleep parameters measuring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.