A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | January 2011 |
| End Date: | November 2012 |
| Contact: | Todd D Rozen, MD, FAAN |
| Email: | tdrozen@geisinger.edu |
| Phone: | 570-808-6026 |
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.
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.
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.
We found this trial at
1
site
1000 E Mountain Blvd
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
(570) 808-7300
Geisinger Wyoming Valley Over the last decade, Geisinger Wyoming Valley has nearly doubled in size,...
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