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Administration of Oxygen to Cluster Headache Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01589588
Enrollment
57
Registered
2012-05-02
Start date
2012-04-30
Completion date
2014-12-31
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cluster Headache Attacks

Keywords

acute treatment

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.

Interventions

DEVICEOpen Hudson Mask

Mask type 1 oxygen

DEVICECluster headache mask with 3 L reservoir

Mask type 2 with oxygen

DEVICEMask 3

Mask type 3 oxygen

DEVICECarnét oxygen demand valve

mask type 3 oxygen

Sponsors

Mads Barløse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy15 minutesPain relief after 15 minutes of treatment

Secondary

MeasureTime frameDescription
Mask preference2 dayssubject mask preference

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026