WEB Consent Form
Project Title:
Sleep and circadian rythms in men and women (Protocol 1)
Study objective
The goal of this study is to understand the role the biological clock plays in sleep disturbances associated with menopause in order to better treat postmenopausal women. We also wish to evaluate the role of melatonin, a hormone naturally produced in your brain, on your sleep and circadian rhythms (i.e. 24-hour rhythms).
Study description
This research project will take place at the Centre for Study and Treatment of Circadian Rhythms at the Douglas Hospital Research Centre. Before the start of study, you will be asked to undergo a screening procedure including visits to the Douglas Hospital Research Centre, and routine medical procedures to ensure that you can safely participate in the study. These screening procedures will be followed by a sleep disorder evaluation during one night in laboratory.
If you successfully complete the screening procedures, your participation to the study will involve the following steps:
1. A 2-week period at home, in which you will be asked to wear a device to measure your activity levels and exposure to light, as well as filling out questionnaires on a smartphone;
2. Immediately followed by about 72 hours in the laboratory spanning 4 consecutive days.
Please note that you will have to stop taking coffee, tea, chocolate or chocolate derivatives, coca-cola or any caffeinated product for the duration of their participation. You will also be asked to stop smoking or taking any drugs during the study.
Pre-screening questionnaire
In order to determine if you are eligible to participate to this study and start the screening procedure, you are welcome to fill out the following questionnaire. This questionnaire consists of approximately 100 questions and should be filled all in one time. Therefore, you should allow approximately 20 minutes to complete it. This online questionnaire will serve as a pre-screening process to determine your eligibility to participate in the study. A member of our team will contact you to let you know if you are eligible, and if this is the case, he/she will provide further information and explain the steps to follow to participate to the study.
Are you obligated to participate?
You can terminate your participation at any time without having to give any justification. If you decide to quit while filling out the questionnaire, you can simply leave the website. You are under no obligation to continue with the next steps even if you complete the questionnaire. If you are eligible to participate, we will contact you to provide further information and explain to you the subsequent steps to become a participant. You can then decide if you want to participate in the research study.
Confidentiality:
The questionnaire data will be treated in a confidential manner. While answering the questionnaire, you will be asked personal questions such as your name, sex, age, level of education, a phone number where you can be reached, and your e-mail address if available. If you accept to participate to this study, a code will be used to identify you. Thus, your confidential information will be protected. Only members of the research team will have access this information.
Prejudice and potential inconveniences:
Some questions may seem bizarre or may seem to have no direct link to your current life situation. You may also feel bored by some questions, which may seem repetitive to you. However, there are no risks or harm, to our knowledge, related to the completion of this screening questionnaire.
Possible benefits:
You will have no direct personal benefit by filling out this questionnaire. This questionnaire will be used to establish your eligibility as a participant to our research project.
Who to contact if I have further questions?
For any questions related to the project, you may contact Dr. Diane B. Boivin or her assistant, Rafael Pérez Medina Carballo at (514) 761-6131 extension 2395 or by e-mail at the following address: rafael.perez@douglas.mcgill.ca.
For questions about your rights as a participant in this research project or if you have any complaints or comments, you can contact the Commissioner for Complaints and Quality Services CIUSSS de l’Ouest-de-l’Île-de-Montréal at 1 844-630-5125 or by email at commissariat.plaintes.comtl@ssss.gouv.qc.ca.
I do not wish to fill out the questionnaire.
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