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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Geisinger Clinic.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Geisinger Clinic Identifier:
First received: February 16, 2011
Last updated: March 15, 2012
Last verified: March 2012

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.

Condition Intervention Phase
Cluster Headache
Drug: Oxygen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache

Resource links provided by NLM:

Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:
  • Reduction in headache pain [ Time Frame: 30 minutes ]
    Headache response after 30 minutes of oxygen treatment. Headache response is defined as a reduction in headache pain intensity from moderate, severe, or very severe pain to mild or no pain.

Secondary Outcome Measures:
  • Headache relief and pain free [ Time Frame: 5 to 60 minutes ]
    1. Percentage of patients with no pain after 30 minutes of treatment
    2. Headache relief and pain free at other time points (5 to 60 minutes)
    3. Reduction of autonomic symptoms at 30 minutes
    4. Any difference in treatment response between episodic and chronic cluster headache patients (if patient #'s allow)
    5. Rescue medication use
    6. Cluster headache recurrence by 24 hours post oxygen treatments
    7. Patient satisfaction with treatment response compared with prior oxygen treatment if have utilized8.Likelihood of choosing this technique again to treat a cluster headache attack

Estimated Enrollment: 12
Study Start Date: January 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continous Flow Oxygen Drug: Oxygen
100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
Experimental: Oxygen Demand Valve Drug: Oxygen
A 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

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01298921

Contact: Todd D Rozen, MD, FAAN 570-808-6026

United States, Pennsylvania
Geisinger Wyoming Valley Recruiting
Wilkes-Barre, Pennsylvania, United States, 18702
Principal Investigator: Todd D Rozen, MD, FAAN         
Sponsors and Collaborators
Geisinger Clinic
Principal Investigator: Todd D. Rozen, MD Geisinger Clinic
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Geisinger Clinic Identifier: NCT01298921     History of Changes
Other Study ID Numbers: 2010-0205
Study First Received: February 16, 2011
Last Updated: March 15, 2012

Keywords provided by Geisinger Clinic:
Cluster Headache
Oxygen Therapy

Additional relevant MeSH terms:
Cluster Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases processed this record on May 25, 2017