Blink reflex changes following oxygen therapy in active cluster headache

Completed

Conditions: cluster headache
Horton headache
10019231

Registration Number: NL-OMON37298

Lead Sponsor: Atrium Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Episodic or chronic cluster headache according to the ICHD-II criteria , diagnosed by a neurologist.
2. Episodic cluster headache patients have to be in a cluster period.
3. Age 18-70 years.

Exclusion Criteria

1. Secondary cluster headache, as diagnosed by the patient*s neurologist.
2. Other primary or secondary headache diagnoses or other painful conditions which could interfere with the patient*s pain perception.
3. Pregnancy or lactation.
4. Chronic obstructive pulmonary disease and other contraindications for oxygen therapy.
5. Intolerability of the oxygen face mask.
6. Rebound cluster headache following oxygen therapy .
7. Previous surgical treatment of the trigeminal nerve or thermolesion of the sphenopalatine ganglion.
8. Side change of cluster headache in the previous year.
9. Incapacitation to understand and sign for informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoints are differences in R2 latency, amplitude, duration,<br /><br>area and habituation measured on both sides between the time points: before a<br /><br>cluster headache attack (without oxygen treatment), immediately after start of<br /><br>the cluster headache attack and after 12-15 minutes of oxygen treatment for the<br /><br>cluster headache attack. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study endpoints are differences in change of R2 latencies,<br /><br>amplitudes, durations, areas and habituation in the 12-15 minutes of oxygen<br /><br>treatment between the groups: clear responders (reduction of pain of at least<br /><br>50% within 15 minutes after the start of oxygen inhalation) and non-responders<br /><br>plus moderate responders (reduction of pain of less than 50% within 15 minutes<br /><br>after the start of oxygen inhalation); differences in R2 latency, amplitude,<br /><br>duration, area and habituation at the aforementioned 3 time points between the<br /><br>symptomatic and asymptomatic side; differences in R2 latency, amplitude,<br /><br>duration, area and habituation before a cluster headache attack without and<br /><br>with oxygen treatment. </p><br>