Professor & patients' paper on the solvable biological challenge of ME/CFS: reader-friendly version
Simon McGrath provides a patient-friendly version of a peer-reviewed paper which highlights some of the most promising biomedical research on ME/CFS ...
Discuss the article on the Forums.

UK, London: RECRUITING NOW: SAFFE trial on enhancing slow-wave sleep in CFS using Xyrem

Discussion in 'Active Clinical Studies' started by Sasha, Jun 8, 2015.

  1. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    During my first bout of illness, people used to say that you couldn't recover from ME until you'd fixed your sleep. I don't know if that's true but some fairly major repair stuff goes on while you're asleep - I don't think it's necessarily a trivial issue in ME.
     
    leokitten, garcia, Blue and 2 others like this.
  2. Valentijn

    Valentijn Senior Member

    Messages:
    14,281
    Likes:
    45,850
    Except many people sleep fine and other symptoms aren't touched :p

    Also, characterizing it as "daytime sleepiness" or "unrefreshing sleep" has never really struck a chord with me. We often need to lie down during the day, and some have reversed sleep cycles, but that's not the same as "sleepiness". And PEM and other symptoms aren't really helped by sleep, but that's not the same as saying that sleep isn't refreshing.

    I think those descriptors very much miss the mark, hence make a rather bad starting point. If they don't properly understand the symptom they are studying, how are they going to come up with a sensible treatment for it?
     
    justy, Wildcat and Sasha like this.
  3. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    I'm not familiar with the survey data on this (actually, I don't know if there is any for ME). Certainly, I wake up every morning feeling like death, and a hell of a lot worse than I did when I went to sleep - I thought that was pretty common for PWME. Sleepiness, not so much but maybe if a PWME isn't sleeping much than they're getting that too.
     
    Sidereal, SOC, nandixon and 1 other person like this.
  4. Valentijn

    Valentijn Senior Member

    Messages:
    14,281
    Likes:
    45,850
    Well, I feel better if I sleep than if I don't sleep. I feel quite horrid if I don't sleep, whereas if I do sleep, I just have my usual ME symptoms waiting for me when I wake up. Sleeping makes me feel refreshed in a purely sleep-related context, even though it does nothing for my other symptoms.
     
    Sidereal, SOC, justy and 1 other person like this.
  5. Nielk

    Nielk

    Messages:
    6,883
    Likes:
    10,630
    As a note of caution, Xyrem is a DANGEROUS drug! Here in the US it is a third grade controlled substance. I was put in it about seven years ago. It is not easy to get it here and is very controlled.

    I had a major adverse reaction the sixth night of taking it. I had hallucinations and went through a major manic episode that lasted a few days. I never experienced anything like it before. Had my husband not stopped me from taking it that night, I probably would have stopped breathing.

    I have since heard from another ME patient with a similar reaction to Xyrem.

    At least it seems like this study is taking place in a hospital under supervision but I would be very weary of other patients taking it at home.
     
    heapsreal, justy and garcia like this.
  6. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,903
    Likes:
    5,385
    Scotland
    Sleep dysfunction in one form or another is optional under Fukuda, ICC and NICE and it's mandatory under CCC and the proposed IOM criteria. PEM may be the defining quality of M.E. but sleep is right up there as one of the most common problems pwME have and well deserving of study in its own right.

    Anyone who experiences persistent insomnia or disturbed sleep month after month or - and I can't bear to think about this - year after year knows how truly miserable it is. An effective sleep med that restores quantity and quality would not provide a little symptomatic relief. It would be a huge QOL improvement.
     
    Indigophoton, heapsreal, SOC and 3 others like this.
  7. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,903
    Likes:
    5,385
    Scotland
    Xyrem is certainly associated with some serious side effects and your experience sounds horrendous.

    It may also be controlled because it's one of the 'date rape' drugs.
     
    Sasha and Nielk like this.
  8. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    I got pretty much laughed out when I asked my GP about it some years ago and I suspect that was partly why.
     
    Scarecrow likes this.
  9. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,903
    Likes:
    5,385
    Scotland
    I fully understand why someone with severe M.E. wouldn't be able to stay in an institution for several nights but what's your solution with respect to the equipment that is required for these studies?

    And who are you to say who has M.E. and who is a "chronic fatiguer"? That's not an invitation for this to thread to go off topic but I'll happily debate this point with you elsewhere.
     
  10. justy

    justy Donate Advocate Demonstrate

    Messages:
    5,355
    Likes:
    12,225
    U.K
    For a person on the moderate severe end of the M.E spectrum I sleep pretty darn well. I go to sleep at a normal reasonable time (about 10 - 11pm) I wake up about 7-8 am and I don't sleep in the day. I do SOMETIMES have nights were I wake frequently and also have to be very careful not to stay up too late, but other than that we are not all the same - I am pretty damn ill right now and have been sleeping very well - I still wake up feeling like shit, and not one of my symptoms has been touched by sleeping better.
     
    Valentijn likes this.
  11. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    I think there's a difference between sleeping without waking and 'sleeping well'. I've been having unbroken sleep for some months now and I still wake up feeling like shit.

    But my theory is that I wake up feeling like shit because something is wrong with the quality of my sleep. I could be wrong of course, but I think it's important not to equate lack of insomnia with 'good sleep'.
     
  12. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    Perhaps we need a new technical term: 'crapsomnia'.
     
    catly, justy and Scarecrow like this.
  13. garcia

    garcia Aristocrat Extraordinaire

    Messages:
    973
    Likes:
    236
    UK
    Several nights? Even one night would be severely uncomfortable for many of the reasons Justy has pointed out in an earlier post. I agree it is a catch-22 as far as the study is concerned. I'm not suggesting the study shouldn't go ahead, merely pointing out that the cohort is likely to be highly selective. Studying ME (what you seem to call severe ME) is not easy. If you pay me a wage I'd be happy to spend time coming up with suggestions, but otherwise I have better things to do with my limited energy.

    I am not categorising any individual as having (or not having) ME. I merely pointed out that due to the nature of the study they were likely to end up mostly with the milder end of the patient spectrum (people with chronic fatigue). Certainly I can't imagine too many ME patients volunteering to take part.
     
    ukxmrv likes this.
  14. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,903
    Likes:
    5,385
    Scotland
    I agree. Over a period of a year I can go through various phases of sleep quantity and apparently quality. The mornings when I wake up feeling the same or better than the previous night are rare indeed, even when sleep is unbroken.

    Here's a review paper on sleep and M.E.
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501671/
    Reduced SWS could have significant consequences for health. For example, human growth hormone is released during SWS.
     
    leokitten, nandixon and Sasha like this.
  15. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,903
    Likes:
    5,385
    Scotland
    So let me check I understand. You say you're not categorising but you then go on to categorise?
     
  16. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    You seem to be saying that there's no such thing as mild ME. There's mild MS, mild Parkinson's, etc. etc. Why would ME suddenly lose its identity and become just 'chronic fatigue' in its mild form?
     
  17. garcia

    garcia Aristocrat Extraordinaire

    Messages:
    973
    Likes:
    236
    UK
    No, that is not what I'm saying. The NHS does not diagnose ME. What it does do is diagnose chronic fatigue (or what it calls CFS/ME) and lumps everyone into that category. So if you do a study on NHS patients with CFS/ME, and make it so they have to stay in hospital for 5-days 3 times, you are likely to end up with a cohort with a lot of chronic fatigue patients, and very few ME patients.
     
    justy, Nielk, Wildcat and 1 other person like this.
  18. ukxmrv

    ukxmrv Senior Member

    Messages:
    4,357
    Likes:
    4,461
    London
    The London ME groups have been approached for potential patients for this study but the conditions are so hard that people can't volunteer. The location for the study is one example. I'd need a quite long and expensive taxi to get there and back. I did once attend this hospital and It's very hard to get to.

    It appeared at one stage the the organisers thought that patients could eat breakfast early (well for us) and then spend the rest of their day in a "day room" watching TV or reading and that normal showers and hospital food would be adequate.

    They didn't seem to take into consideration the problems with an altered "energy" pattern (I know that isn't the right word sorry), the noise, light and cognitive sensitivity that patients have plus the inability of many of us to shower, eat or have a daily rhythm like ambulatory hospital patients. Let alone problems with regulating heat/cold, going to the loo 20 times a night and all the usual ME things without even considering the effects of a drug trial.

    I've not seen the latest info about this trial so my impressions may be out of date. I would deteriorate under the conditions I originally read about and members of my local group all had the same concerns but at the same time wanted to help and support drug trials.
     
    Last edited: Jun 12, 2015
    Sidereal, justy, Valentijn and 2 others like this.
  19. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    This study is CCC - they're not using NHS diagnostic criteria.
     
    garcia, Valentijn and Scarecrow like this.
  20. Sasha

    Sasha Fine, thank you

    Messages:
    12,803
    Likes:
    34,273
    UK
    I'd also be unable to cope in hospital but I hope they'll get some patients volunteering who are well enough to cope. It's not idea but as has been pointed out, medical supervision is important and there's a load of expensive equipment so doing this in the homes of severe patients would be fabulously expensive. Which is not to say it's not worth doing, but that's not this trial.
     
    garcia and justy like this.

See more popular forum discussions.

Share This Page