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Cluster Headache Help and Support >> Medications,  Treatments,  Therapies >> New Oxygen Therapy Study Taking Enrollment
http://www.clusterheadaches.com/cgi-bin/yabb2/YaBB.pl?num=1294692148

Message started by Batch on Jan 10th, 2011 at 3:42pm

Title: New Oxygen Therapy Study Taking Enrollment
Post by Batch on Jan 10th, 2011 at 3:42pm
Good People of Clusterville,

Great News!  The Geisinger Center for Clinical Studies in Wyoming Valley, near Wilkes-Barre, PA, is now taking enrollment for a new study of oxygen therapy for cluster headaches.  This study will compare the results at a flow rate of 15 liters/minute with a new method of aborting cluster headaches administered by oxygen demand valve at respiration rates that support hyperventilation.

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This is the study Michael Berger, Royce Fishman, and I started working on in late 2007.  Dr. Todd Rozen, MD, Geisinger Neurosciences Institute is the Principal Investigator.

I drove up to the Geisinger Center for Clinical Studies in November to train members of the staff that will be supporting this study.  They're ready.

I'm confident that when the results of this study come out they'll generate a lot more interest and exposure on the use of oxygen therapy as an abortive for the cluster headache.  Cluster headache sufferers are going to need it...

Now for the Bad News...  On 4 January 2011, the bureaucrats and bean counters at the Centers for Medicare and Medicaid Services (CMS) published their Coverage Determination on the use of oxygen therapy for cluster headaches, stating: "the evidence does not demonstrate that the home use of oxygen to treat cluster headache improves health outcomes in Medicare beneficiaries with cluster headache (CH). Therefore, we determine that home use of oxygen to treat CH is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act (the Act)."

See how your tax dollars were spent at the following link:

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I won't politicize this action by CMS any further, but a civil email or phone call to your Senators and Representative pointing out what this means to you as a cluster headache sufferer is in order. 

You also need to understand that many medical insurance companies use CMS Coverage Determinations to set their own coverage policies and that this action by CMS has a high probability of making it even more difficult to obtain oxygen therapy.

Take care,

V/R, Batch

Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by Brew on Jan 10th, 2011 at 8:12pm
That totally BLOWS about the CMS ruling. Who the f*ck do they think they are anyhow?

Bottom line is that it really shouldn't affect most of us since welder's o2 is so easy to come by.

Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by E-Double on Jan 11th, 2011 at 6:20am
Nice with the study not with the gov!

btw when did Rozen leave MHNI?
( i guess I could google)

Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by JustNotRight on Jan 11th, 2011 at 6:43am
Great News Pete!  Except for the CMS ruling...  >:(  Aren't they supposed to help the patient and follow the Doctors Credo 'First do no Harm"?

Anywho hoping I hear back from Rozen soon been on his waiting list for almost a year. 

Got your Email Pete all taken care of   :)

Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by JustNotRight on Feb 11th, 2011 at 1:24pm
Update:

They still need more people for the O2 study with Dr. Rozen anyone within the PA, NY, NJ, VA, MD, CT, WV areas should contact the study coordinator , go to START PRINTPAGEMultimedia File Viewing and Clickable Links are available for Registered Members only!!  You need to Login or RegisterEND PRINTPAGE and click the contact me about this study link or call the number at the bottom of the study info.

I participated and the on demand method is AWESOME give it a go people we need your help to get this FDA approved!!

Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by JustNotRight on Feb 12th, 2011 at 8:36am
With the demand method you basically hyperventilate the 1st few min. and then go to deep breathing with it.

In a nut shell... the 15 lpm did not work for me but the demand method did.


Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by JustNotRight on Feb 16th, 2011 at 6:33am
Yes, and all we need is FDA approval with the help of this study.  Without the FDA approval ins. co's will not cover this type of treatment.

Title: Re: New Oxygen Therapy Study Taking Enrollment
Post by cluster on Apr 26th, 2011 at 7:18am
Press report, please see:

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- Oh no, why that picture??? - They do accept comments on the Daily Mail website.

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