A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache
A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache
Cluster headache is a disorder marked by frequent attacks of short-lasting, severe,
 unilateral head pain with associated autonomic symptoms. It is the most severe head pain
 syndrome known. Currently, the two most common treatments for cluster headaches are inhaled
 oxygen and injectable sumatriptan. These treatments do not work for all cluster headache
 patients, and patients who smoke may eventually develop contraindication to triptans. New
 treatment options are needed.

 An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve
 that is controlled by respiration rate, allowing increased oxygen flow in response to
 increased demand. This system may be more efficacious at stopping a cluster headache attack
 than the currently prescribed oxygen delivery system.

 This study will compare the effectiveness of oxygen delivered via demand valve versus
 continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster
 headache attack. All patients will treat one cluster headache with each of the 2 treatment
 methods.
Cluster headache is a primary headache disorder marked by frequent attacks of short-lasting,
 severe, unilateral head pain with associated autonomic symptoms. The goal of acute therapy
 for cluster headache is fast, effective and consistent relief.

 In the currently recommended dosing strategy of continuous flow 100% oxygen given via a
 non-rebreather face mask at 7-15L/min, the time to improvement can sometimes take upwards of
 20-30 minutes and is not effective for all cluster headache sufferers.

 An alternative method of oxygen delivery (versus continuous flow) uses a demand valve which
 is controlled by the respiration rate, allowing increased oxygen flow in response to
 increased demand. This delivery system may be better at stopping a cluster headache attack
 than the continuous flow model as it can support hyperventilation which can enhance cerebral
 arterial vasoconstriction via a state of hyperoxia and hypocapnia. Arterial vasoconstriction
 is one hypothesized method by which oxygen can abort a cluster headache attack.

 This proof of concept trial will evaluate if oxygen delivered via demand valve with a
 specific breathing technique is effective as a cluster headache acute treatment and is more
 effective than the traditional continuous high flow oxygen treatment with a non-rebreather
 face mask.
Inclusion Criteria:

 -  Men or women 18 to 65 with history of moderate severe or very severe cluster headaches
 and currently in a cluster headache period or cycle are included.

 Exclusion Criteria:

 -  Subjects who have a history of chronic obstructive lung disease, those who have major
 neurologic disorders other than cluster headaches, those with a history of syncope, or
 lightheadedness with hyperventilation and pregnant women are excluded.