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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01298921
Recruitment Status : Terminated (PI left Geisinger-study terminated prematurely - 4 patients enrolled)
First Posted : February 18, 2011
Results First Posted : April 12, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Cluster Headache Drug: Oxygen Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache
Study Start Date : January 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298921


Locations
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United States, Pennsylvania
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Geisinger Clinic
Investigators
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Principal Investigator: Todd D. Rozen, MD Geisinger Clinic
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT01298921    
Other Study ID Numbers: 2010-0205
First Posted: February 18, 2011    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: July 11, 2019
Last Verified: April 2019
Keywords provided by Geisinger Clinic:
Headache
Cluster Headache
Oxygen Therapy
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases