Oxygen treatment for cluster headache attacks at different flow rates. A double-blind, randomized, cross-over design study.
- Conditions
- 10019231cluster headacheHorton headache
- Registration Number
- NL-OMON37264
- Lead Sponsor
- Atrium Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
All newly diagnosed cluster headache patients of at least 18 years of age and known cluster headache patients of at least 18 years of age who are naïve to oxygen treatment.
- All patients who used oxygen in the past.
- Pregnancy or lactation.
- COPD and other contraindications for oxygen therapy, as determined by the patients* physicians.
- Secondary cluster headache. Patients might be included before imaging is conducted. If so, they will be excluded afterwards when they are diagnosed as secondary cluster headache.
- Other primary or secondary headache diagnoses or other distracting painful conditions which could interfere with the patient*s pain perception.
- Incapacitation to understand and sign for informed consent.
- Patients living outside a designated insurance zone, as costs of the adapted oxygen tanks will not be covered elsewhere.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the difference in VAS score before and after oxygen<br /><br>treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is the percentage of successfully treated attacks as<br /><br>defined by a drop in VAS score of over 50% within 15 minutes.</p><br>