NCT01298921

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

April 12, 2019

Completed
Last Updated

July 11, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

February 16, 2011

Results QC Date

January 14, 2019

Last Update Submit

April 23, 2019

Conditions

Cluster Headache

Keywords

HeadacheCluster HeadacheOxygen Therapy

Outcome Measures

Primary Outcomes (1)

  • Reduction in Headache Pain

    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.

    30 minutes

Secondary Outcomes (1)

  • Headache Relief and Pain Free

    5 to 60 minutes

Study Arms (2)

Continous Flow Oxygen

ACTIVE COMPARATOR
Drug: Oxygen

Oxygen Demand Valve

EXPERIMENTAL
Drug: Oxygen

Interventions

OxygenDRUG

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

Oxygen Demand Valve

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Related Publications (1)

  • Rozen TD, Fishman RS. Demand valve oxygen: a promising new oxygen delivery system for the acute treatment of cluster headache. Pain Med. 2013 Apr;14(4):455-9. doi: 10.1111/pme.12055. Epub 2013 Jan 31.

    PMID: 23369112DERIVED

Related Links

MeSH Terms

Conditions

Cluster HeadacheHeadache

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Results Point of Contact

Title
Office of Research Compliance
Organization
Geisinger Health System
orc@geisinger.edu
570-214-9628

Study Officials

  • Todd D. Rozen, MD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 18, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

July 11, 2019

Results First Posted

April 12, 2019

Record last verified: 2019-04

Locations

US(1)