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Thanks to a recommendation, I emailed about a study on the effects of Sodium Oxybate on ME/CFS and received a response in the affirmative that I could attend if I wish.
I was hoping you guys could take a glance and let me know what you think? (below)
Has anyone partaken in a trial before? It mentions there is no personal gain from the trial and of course I could be part of the placebo group but does anyone know if you even find out which group you are in in the end?
Even if it were to help and and I couldn't get it regularly after the trial or if it did nothing, it may put another tiny piece of the puzzle back?
Many thanks :
Study title: Slow-wave sleep and daytime functioning in chronic fatigue syndrome: effects of sodium oxybate
Study number: SAFFE 2012
You are being invited to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with your friends and relatives if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
Part 1
What is the purpose of the study?
We want to find out if enhancing a particular stage of sleep (deep, so-called slow wave sleep) will improve daytime function in people with chronic fatigue syndrome (CFS).
Why have I been chosen?
You have been chosen because you have CFS. We need 12 volunteers to complete the study and you have requested further information. If you decide to take part you will be asked to sign a consent form and you will be given a copy of this to keep. A doctor will give you a medical examination to make sure that you meet the requirements for the study.
Do I have to take part?
No, it is up to you if you take part or not. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you don’t want to take part you don’t have to give a reason. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive or your participation in future studies. However, if you do withdraw from the study prematurely, you will still be asked to attend for a follow-up visit for your own benefit and to ensure your safety. Any information collected in the study prior to your withdrawal may be used by us in the analysis of the study
What will I be asked to do if I take part in the research study?
If you decide that you would like to take part you need to attend for 3 visits in total at the NIHR/Wellcome Trust Imperial Clinical Research Facility in the Hammersmith Hospital. The first is for a consent and screening visit. The medical screening part takes approximately 2 hours, which will be followed by an overnight stay with a sleep recording to make sure you are suitable for the study. If you cannot stay overnight on the day of the first visit, you can return for this on a different date. The next two visitsare periods of 5 days from Monday early afternoon until Friday late afternoon, separated by at least a week.
The study medication treatment might harm an unborn child; therefore you should not take part in this study if you are pregnant, breast-feeding or you may become pregnant during the study period. If you could become pregnant, we will ask you to have a pregnancy test (urine or blood) before taking part. You must agree to use a reliable form of contraception during the trial ( e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom). This should be continued for at least one month after the treatment has finished. If you do become pregnant during the course of the study, we would ask you to tell your study doctor immediately so we can help decide appropriate action. We would discuss referral for specialist counselling on the possible risks to your unborn baby and arrangements will be offered to monitor the health of both yourself and your unborn baby. The pharmaceutical company which supplies the medication may also request your consent to collect information about your health and that of the baby.
Screening Visit After discussion of the study and the consent procedure, screening tests will be performed to decide if you are suitable for the study.
These tests will include:-
A pregnancy test, if appropriate; a complete physical examination including questions about your medical, psychiatric and family history and medication use; a record of your height, weight, blood pressure and pulse; a recording of your heart (ECG); blood samples (approximately 15ml which is the same as 3 teaspoons) for laboratory tests to ensure that these are within the normal range.
An overnight sleep recording will be performed that evening. Your evening meal and breakfast are provided and there areshowering facilities available (for details of sleep monitoring see part 2).
You will also be given a small wrist monitor to wear called an actiwatch, which will give us an idea of your usual rest and activity routines. We ask you to wear the actiwatch until you come in for your first study week, and then again between the first and the second study weeks. We will also give you a simple activity diary to complete while you are wearing the actiwatch. We will inform your GP in writing of your planned participation in the study.
Study Periods If the results of the screening visit are satisfactory you will be required to attend the NIHR/Wellcome Trust Imperial Clinical Research Facility for 2 periods of 5 days. During this time all meals and refreshments are provided. Showering facilities are available and bed linen is provided. There is a patient lounge which you are welcome to use with other patients which has computers and a television /DVD player, books and magazines. There is also wifi internet access available if you bring your own devices.
You will be admitted early on the Monday afternoon, and discharged on Friday in the late afternoon. We’ll be giving you the study medication (details in below and in Part 2) each night for 4 nights, and measuring your sleep overnight each night.
Monday
We shall first check that you are happy to proceed, then do some brief health checks including breathalyser and urine test for drugs of abuse. You will not be eligible if you feel unwell in any way, or have taken alcohol in the previous 24 hours, or taken any drugs of abuse in the last week.
We will prepare you for the sleep recording, give you the study medication, and record your sleep overnight. Details of the procedure are given in Part 2 of this sheet.
Tuesday
You’ll be woken at your usual rise time or 8 am if earlier. You will be disconnected from the recording equipment, but retain the leads attached to your head. This means you will be unable to shower or bath until the late afternoon although you will be able to wash. You’ll have breakfast and complete a questionnaire about the previous night’s sleep. During the day we’ll be doing some tests of sleepiness, mental function and muscle strength, described more fully in Part 2. In the late afternoon we’ll take off the leads, and you’ll be free to watch TV, read etc for the evening. At your usual bedtime we’ll ask you to take the study medication again with a minimal sleep recording.
Wednesday
You’ll be woken at your usual rise time or 8 am if earlier. We’ll ask you to do a sleep questionnaire, and then you’re free for the rest of the day. You will be able to go out if you wish, as long as you inform the staff at the research centre, and return in time for your evening meal. At your usual bedtime we’ll ask you to take the study medication again, with a minimal sleep recording.
Thursday
You’ll be woken at your usual rise time or 8 am if earlier. We’ll ask you to do a sleep questionnaire, and then you’ll be free during the day as Wednesday, but after evening meal we’ll apply the recording electrodes and record your sleep as on Monday. We’ll ask you to take the study medication again.
Friday
You’ll be woken at your usual rise time or 8 am if earlier. You will be disconnected from the recording equipment, but retain the leads attached to your head. This means you will be unable to shower or bath until the late afternoon although you will be able to wash. You’ll have breakfast and complete a questionnaire about the previous night’s sleep. During the day we’ll be doing the same tests of sleepiness, mental function and muscle strength as on Tuesday. In the late afternoon we’ll take off the leads, check your health and then you’ll be discharged home.We will give you some sleep questions to do at home over the next few days.
About a week after the second study period we will contact you by telephone to check your health.
What is the drug that is being tested?
On each of the four nights in each of the 2 periods, you will be given adose of a liquid medication (about 60ml, about 4 tablespoons). It will be either a drug called sodium oxybate, 3 grams, or an inactive placebo. Neither you nor the investigators will know which one you take in which study period. This is so that any changes in the measurements we take are not biased by expectation.The drug has been licensed since 2005 for the treatment of a symptom called cataplexy in people with the sleep disorder narcolepsy. There is more information about the drug in Part 2 of this document
What are my responsibilities?
· You must attend for both the study periods, or let us know if in plenty of time if you cannot be there.
· You must report any changes in your health to one of the study team.
· You must not take any illicit drugs during the whole study, and no alcohol on the day and evening before each study period
What are the risks of taking part?
There is no risk from any of the measurements we take, except for a slight risk of bruising from the screening blood test.
As with any drug, some people can experience side effects. The most common one for sodium oxybate is sedation, and as you will be taking it at night, you may not be aware of this. A list of other side effects which patients who take the drug regularly have experienced is given in part 2.
If you experience any change in your health during the study you must tell us about it.
How will I benefit from participating?
You will not benefit from taking part.
How will we use the results of this research?
We will publish the results in a scientific journal.
Confidentiality
All our records on you are confidential and the measurements we collect are kept in files only identified by a study number.
What if something goes wrong?
Medical cover is provided by the research centre physicians throughout the study, including full emergency medical cover during the study periods. You will be given a contact number should you be worried about your health once you have returned home.
Imperial College London holds negligent harm and non-negligent harm insurance policies which apply to this study. If you experience serious and enduring harm or injury as a result of taking part in this study, you may be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation.
If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform one of the investigators, contact details at the beginning of this information sheet. The normal National Health Service complaint complaints mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial AHSC Joint Research Office.
Other information
This study is sponsored by Imperial College and has been approved by the London Brent Research Ethics Committee. It has been funded by the Medical Research Council. The study will follow the principles laid down in the Declaration of Helsinki.
Your participation in this study is voluntary. Should you decide to take part, you will be asked to sign a consent form. You will be able to withdraw from the study at any time, without giving a reason if you do not wish to. However, we will require you to come in for a health check if this happens.
Your reasonable travelling expenses will be reimbursed.
If you have any questions at any time about the study, please do not hesitate to contact the research team using the address and email provided at the beginning of this information sheet. A summary of the study can also be found at :http://www1.imperial.ac.uk/departmentofmedicine/divisions/brainsciences/psychopharmacology/saffe/
Thank you for reading this information sheet and for considering taking part in this study.
I was hoping you guys could take a glance and let me know what you think? (below)
Has anyone partaken in a trial before? It mentions there is no personal gain from the trial and of course I could be part of the placebo group but does anyone know if you even find out which group you are in in the end?
Even if it were to help and and I couldn't get it regularly after the trial or if it did nothing, it may put another tiny piece of the puzzle back?
Many thanks :
Study title: Slow-wave sleep and daytime functioning in chronic fatigue syndrome: effects of sodium oxybate
Study number: SAFFE 2012
You are being invited to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with your friends and relatives if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
Part 1
What is the purpose of the study?
We want to find out if enhancing a particular stage of sleep (deep, so-called slow wave sleep) will improve daytime function in people with chronic fatigue syndrome (CFS).
Why have I been chosen?
You have been chosen because you have CFS. We need 12 volunteers to complete the study and you have requested further information. If you decide to take part you will be asked to sign a consent form and you will be given a copy of this to keep. A doctor will give you a medical examination to make sure that you meet the requirements for the study.
Do I have to take part?
No, it is up to you if you take part or not. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you don’t want to take part you don’t have to give a reason. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive or your participation in future studies. However, if you do withdraw from the study prematurely, you will still be asked to attend for a follow-up visit for your own benefit and to ensure your safety. Any information collected in the study prior to your withdrawal may be used by us in the analysis of the study
What will I be asked to do if I take part in the research study?
If you decide that you would like to take part you need to attend for 3 visits in total at the NIHR/Wellcome Trust Imperial Clinical Research Facility in the Hammersmith Hospital. The first is for a consent and screening visit. The medical screening part takes approximately 2 hours, which will be followed by an overnight stay with a sleep recording to make sure you are suitable for the study. If you cannot stay overnight on the day of the first visit, you can return for this on a different date. The next two visitsare periods of 5 days from Monday early afternoon until Friday late afternoon, separated by at least a week.
The study medication treatment might harm an unborn child; therefore you should not take part in this study if you are pregnant, breast-feeding or you may become pregnant during the study period. If you could become pregnant, we will ask you to have a pregnancy test (urine or blood) before taking part. You must agree to use a reliable form of contraception during the trial ( e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom). This should be continued for at least one month after the treatment has finished. If you do become pregnant during the course of the study, we would ask you to tell your study doctor immediately so we can help decide appropriate action. We would discuss referral for specialist counselling on the possible risks to your unborn baby and arrangements will be offered to monitor the health of both yourself and your unborn baby. The pharmaceutical company which supplies the medication may also request your consent to collect information about your health and that of the baby.
Screening Visit After discussion of the study and the consent procedure, screening tests will be performed to decide if you are suitable for the study.
These tests will include:-
A pregnancy test, if appropriate; a complete physical examination including questions about your medical, psychiatric and family history and medication use; a record of your height, weight, blood pressure and pulse; a recording of your heart (ECG); blood samples (approximately 15ml which is the same as 3 teaspoons) for laboratory tests to ensure that these are within the normal range.
An overnight sleep recording will be performed that evening. Your evening meal and breakfast are provided and there areshowering facilities available (for details of sleep monitoring see part 2).
You will also be given a small wrist monitor to wear called an actiwatch, which will give us an idea of your usual rest and activity routines. We ask you to wear the actiwatch until you come in for your first study week, and then again between the first and the second study weeks. We will also give you a simple activity diary to complete while you are wearing the actiwatch. We will inform your GP in writing of your planned participation in the study.
Study Periods If the results of the screening visit are satisfactory you will be required to attend the NIHR/Wellcome Trust Imperial Clinical Research Facility for 2 periods of 5 days. During this time all meals and refreshments are provided. Showering facilities are available and bed linen is provided. There is a patient lounge which you are welcome to use with other patients which has computers and a television /DVD player, books and magazines. There is also wifi internet access available if you bring your own devices.
You will be admitted early on the Monday afternoon, and discharged on Friday in the late afternoon. We’ll be giving you the study medication (details in below and in Part 2) each night for 4 nights, and measuring your sleep overnight each night.
Monday
We shall first check that you are happy to proceed, then do some brief health checks including breathalyser and urine test for drugs of abuse. You will not be eligible if you feel unwell in any way, or have taken alcohol in the previous 24 hours, or taken any drugs of abuse in the last week.
We will prepare you for the sleep recording, give you the study medication, and record your sleep overnight. Details of the procedure are given in Part 2 of this sheet.
Tuesday
You’ll be woken at your usual rise time or 8 am if earlier. You will be disconnected from the recording equipment, but retain the leads attached to your head. This means you will be unable to shower or bath until the late afternoon although you will be able to wash. You’ll have breakfast and complete a questionnaire about the previous night’s sleep. During the day we’ll be doing some tests of sleepiness, mental function and muscle strength, described more fully in Part 2. In the late afternoon we’ll take off the leads, and you’ll be free to watch TV, read etc for the evening. At your usual bedtime we’ll ask you to take the study medication again with a minimal sleep recording.
Wednesday
You’ll be woken at your usual rise time or 8 am if earlier. We’ll ask you to do a sleep questionnaire, and then you’re free for the rest of the day. You will be able to go out if you wish, as long as you inform the staff at the research centre, and return in time for your evening meal. At your usual bedtime we’ll ask you to take the study medication again, with a minimal sleep recording.
Thursday
You’ll be woken at your usual rise time or 8 am if earlier. We’ll ask you to do a sleep questionnaire, and then you’ll be free during the day as Wednesday, but after evening meal we’ll apply the recording electrodes and record your sleep as on Monday. We’ll ask you to take the study medication again.
Friday
You’ll be woken at your usual rise time or 8 am if earlier. You will be disconnected from the recording equipment, but retain the leads attached to your head. This means you will be unable to shower or bath until the late afternoon although you will be able to wash. You’ll have breakfast and complete a questionnaire about the previous night’s sleep. During the day we’ll be doing the same tests of sleepiness, mental function and muscle strength as on Tuesday. In the late afternoon we’ll take off the leads, check your health and then you’ll be discharged home.We will give you some sleep questions to do at home over the next few days.
About a week after the second study period we will contact you by telephone to check your health.
What is the drug that is being tested?
On each of the four nights in each of the 2 periods, you will be given adose of a liquid medication (about 60ml, about 4 tablespoons). It will be either a drug called sodium oxybate, 3 grams, or an inactive placebo. Neither you nor the investigators will know which one you take in which study period. This is so that any changes in the measurements we take are not biased by expectation.The drug has been licensed since 2005 for the treatment of a symptom called cataplexy in people with the sleep disorder narcolepsy. There is more information about the drug in Part 2 of this document
What are my responsibilities?
· You must attend for both the study periods, or let us know if in plenty of time if you cannot be there.
· You must report any changes in your health to one of the study team.
· You must not take any illicit drugs during the whole study, and no alcohol on the day and evening before each study period
What are the risks of taking part?
There is no risk from any of the measurements we take, except for a slight risk of bruising from the screening blood test.
As with any drug, some people can experience side effects. The most common one for sodium oxybate is sedation, and as you will be taking it at night, you may not be aware of this. A list of other side effects which patients who take the drug regularly have experienced is given in part 2.
If you experience any change in your health during the study you must tell us about it.
How will I benefit from participating?
You will not benefit from taking part.
How will we use the results of this research?
We will publish the results in a scientific journal.
Confidentiality
All our records on you are confidential and the measurements we collect are kept in files only identified by a study number.
What if something goes wrong?
Medical cover is provided by the research centre physicians throughout the study, including full emergency medical cover during the study periods. You will be given a contact number should you be worried about your health once you have returned home.
Imperial College London holds negligent harm and non-negligent harm insurance policies which apply to this study. If you experience serious and enduring harm or injury as a result of taking part in this study, you may be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation.
If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform one of the investigators, contact details at the beginning of this information sheet. The normal National Health Service complaint complaints mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial AHSC Joint Research Office.
Other information
This study is sponsored by Imperial College and has been approved by the London Brent Research Ethics Committee. It has been funded by the Medical Research Council. The study will follow the principles laid down in the Declaration of Helsinki.
Your participation in this study is voluntary. Should you decide to take part, you will be asked to sign a consent form. You will be able to withdraw from the study at any time, without giving a reason if you do not wish to. However, we will require you to come in for a health check if this happens.
Your reasonable travelling expenses will be reimbursed.
If you have any questions at any time about the study, please do not hesitate to contact the research team using the address and email provided at the beginning of this information sheet. A summary of the study can also be found at :http://www1.imperial.ac.uk/departmentofmedicine/divisions/brainsciences/psychopharmacology/saffe/
Thank you for reading this information sheet and for considering taking part in this study.
