Cluster Headache | A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache

Cluster Headache research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cluster Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:OxygenA demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate

Drug:Oxygen100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Continous Flow Oxygen

Oxygen Demand Valve

Study Status


Start Date: January 2011

Completed Date: July 2012

Phase: Phase 1

Type: Interventional


Primary Outcome: Reduction in Headache Pain

Secondary Outcome: Headache Relief and Pain Free

Study sponsors, principal investigator, and references

Principal Investigator: Todd D. Rozen, MD

Lead Sponsor: Geisinger Clinic


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