Administration of Oxygen to Cluster Headache Patients

Mads Barløse

Status: Completed

Conditions: Cluster Headache Attacks

Treatments: Device: Cluster headache mask with 3 L reservoir; Device: Mask 3; Device: Carnét oxygen demand valve; Device: Open Hudson Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01589588

H-2-2011-163

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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57 participants in 4 patient groups, including a placebo group

Mask 1

Experimental group

Treatment:

Device: Open Hudson Mask

Mask 2

Experimental group

Treatment:

Device: Cluster headache mask with 3 L reservoir

Mask 3

Experimental group

Treatment:

Device: Carnét oxygen demand valve

Device: Carnét oxygen demand valve

Device: Mask 3

Mask 3, placebo

Placebo Comparator group

Treatment:

Device: Carnét oxygen demand valve

Device: Carnét oxygen demand valve