Administration of Oxygen to Cluster Headache Patients

Not Applicable

Completed

• Conditions: Cluster Headache Attacks
• Interventions: Device: Cluster headache mask with 3 L reservoir; Device: Mask 3; Device: Carnét oxygen demand valve; Device: Open Hudson Mask

• Registration Number: NCT01589588
• Lead Sponsor: Mads Barløse

Brief Summary

This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• episodic cluster headache
• regular occurance of attacks and cluster for 2 years
• 2-8 attacks / day
• cluster periods of over 14 days
• duration of current cluster period max 14 days
• ability to differentiate between attacks of CH and other forms of headache

Exclusion Criteria

• Changes in prophylactic treatment a week before trial
• pregnancy or breastfeeding women
• serious somatic or psychiatric disease
• COLD
• chronic or primary or secondary headache > 14 days / month other than CH
• alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mask 2	Cluster headache mask with 3 L reservoir	-
Mask 3	Mask 3	-
Mask 3, placebo	Carnét oxygen demand valve	-
Mask 3	Carnét oxygen demand valve	-
Mask 1	Open Hudson Mask	-

Primary Outcome Measures

Name	Time	Method
Efficacy	15 minutes	Pain relief after 15 minutes of treatment

Secondary Outcome Measures

Name	Time	Method
Mask preference	2 days	subject mask preference

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark