Duke study, poor design

[WillowJ]

Sleep study, "Behavioral Insomnia Therapy With Chronic Fatigue Syndrome"

Makes the correct points,

The vast majority of CFS patients complain of unrelenting sleep disturbances (e.g., sleep onset insomnia and/or sleep maintenance insomnia) that could exacerbate symptoms such as fatigue, mood disturbance, and reduced quality of life.
...
the sleep-specific treatment needs of CFS patients have been largely ignored.

Makes the outrageous hypothesis:

Both our clinical observations and our preliminary studies suggest that those with CFS display sleep targets (i.e., increased time-in-bed, decreased daytime activity) that are common to those with Primary and other comorbid insomnias. These phenomena are known to perpetuate sleep problems, and likely account for the chronic insomnia among CFS patients. Given the high prevalence and cost associated with CFS, as well as its complex clinical picture, interventions that directly address perpetuating mechanisms would likely improve the sleep and general prognosis for these patients.

They state the inclusion critera as:

Chronic Fatigue Syndrome and Insomnia

• meet diagnostic criteria for insomnia
• be diagnosed with CFS by the Study Physician using CDC criteria
• must be in current treatment for CFS (we can provide referrals if needed).
• under medical care for a minimum of 6 weeks with a stable medication regimen for > 1 month.

Study patients can have comorbid depression (as long as it is not bipolar, melancholic or psychotic) or fibromyalgia. They can be taking sleep medications.

The usual exclusion criteria, plus past history of major psychiatric-classified diseases if considered resolved for at least 5 years. The this:

We will exclude those meeting criteria for Narcolepsy, Restless Legs Syndrome, a Circadian Rhythm Disorder, or sleep apnea and/or hypopnea

Ha! So they will have no ME/CFS patients in their study at all, or hardly any, because we have those things in every proper study that has ever been done. Narcolepsy is hypothesized to be a feature of ME, hypopnea has been very well replicated...

GIGO

We should track their progress, and if they get enough participants, we can then go ahead and start writing letters to send to whatever journal would publish their results.

http://www.clinicaltrials.gov/ct2/show/NCT00540254

 

[TheMoonIsBlue]

Even Circadian Rhythm Disorder is excluded? That is even part of the CCC I believe. I'd guess atleast 50% of ME/CFS patients with insomnia and other sleep problems have Circadian Rhythm Disorders. Many have RLS, hypoapnea. You're right, this is a poorly designed study. Participants will be "be diagnosed with CFS by the Study Physician using CDC criteria"......also "Study patients can have comorbid depression".

Looks like another pointless study. DUMP the CDC CRITERIA!!! We're back in 1990 with that junk!!!

I can't believe the amount of $$$$$ wasted on crap studies.

 

[WillowJ]

ya, even that

pointless

I wonder if we could get someone (with a Ph.D.) to write to Duke's review board, and point out that they are wasting their funds?

 

[Snow Leopard]

Circadian Rhythm Disorder is common and the reason is because our biorhythms only demand 7-8 hours sleep, yet for many, our body demands 12+ hours. This incompatibility causes a shifting wake/sleep pattern.