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

• Sponsor: Geisinger Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01298921
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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; 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.

Study Design

• Study Type: Interventional
• 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: Jan 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reduction in Headache Pain [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 [5 to 60 minutes]

   Percentage of patients with no pain after 30 minutes of treatment Headache relief and pain free at other time points (5 to 60 minutes) Reduction of autonomic symptoms at 30 minutes Any difference in treatment response between episodic and chronic cluster headache patients (if patient #'s allow) Rescue medication use Cluster headache recurrence by 24 hours post oxygen treatments 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania	United States	18702

Sponsors and Collaborators

• Geisinger Clinic

Investigators

• Principal Investigator: Todd D. Rozen, MD, Geisinger Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Geisinger Health System

Publications

None provided.

• Responsible Party: Geisinger Clinic
• ClinicalTrials.gov Identifier: NCT01298921
• Other Study ID Numbers: 2010-0205
• First Posted: Feb 18, 2011
• Last Update Posted: Jul 11, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Geisinger Clinic: Headache; Cluster Headache; Oxygen Therapy
• Additional relevant MeSH terms: Cluster Headache; Headache

Study Results

Participant Flow

Pre-assignment Detail	After the enrollment of 4 participants in this study, the PI left Geisinger and the study was terminated. Geisinger does not have any details regarding which Arm/Group participants completed. Therefore, 0 was added as the enrollment for each group.

Arm/Group Title	Continous Flow Oxygen	Oxygen Demand Valve
Arm/Group Description	Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes	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
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Continous Flow Oxygen	Oxygen Demand Valve	Total
Arm/Group Description	Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes	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	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Count of Participants () []

Outcome Measures

1. Primary Outcome

Title	Reduction in Headache Pain
Description	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.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).

Arm/Group Title	Continous Flow Oxygen	Oxygen Demand Valve
Arm/Group Description	Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes	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
Measure Participants	0	0

2. Secondary Outcome

Title	Headache Relief and Pain Free
Description	Percentage of patients with no pain after 30 minutes of treatment Headache relief and pain free at other time points (5 to 60 minutes) Reduction of autonomic symptoms at 30 minutes Any difference in treatment response between episodic and chronic cluster headache patients (if patient #'s allow) Rescue medication use Cluster headache recurrence by 24 hours post oxygen treatments 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
Time Frame	5 to 60 minutes

Outcome Measure Data

Analysis Population Description

Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).

Arm/Group Title	Continous Flow Oxygen	Oxygen Demand Valve
Arm/Group Description	Oxygen: 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes	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
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).
Arm/Group Title	Continous Flow Oxygen		Oxygen Demand Valve
Arm/Group Description	Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes		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
All Cause Mortality
	Continous Flow Oxygen		Oxygen Demand Valve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Continous Flow Oxygen		Oxygen Demand Valve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Continous Flow Oxygen		Oxygen Demand Valve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.