Blink reflex changes following oxygen therapy in active cluster headache

Blink reflex changes following oxygen therapy in active cluster headache - Blink reflex changes following oxygen therapy in active cluster headache

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37298

Enrollment

Registered

2012-07-10

Start date

2012-09-14

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

cluster headache Horton headache

Interventions

All patients will be treated with 100% percent oxygen at a flow rate of 12 L/minute, given 3 minutes after pain onset for 15 minutes, using a non-rebreathing facial mask.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)