To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks.
Conditions
Interventions
Trade Name: Oxygen, compressed
Product Name: Oxygen, compressed
Product Code: O2
Pharmaceutical Form: Medicinal gas, compressed
Sponsors
Dept. of Neurology, Atrium Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks. ;Secondary Objective: - Identifying subgroups in which oxygen at flow rates of 7 L/min or 12 L/min is more effective. - To determine whether the rebound effect known to occur in oxygen treatment is more frequently observed in one of the different flow rates or whether this is an effect independent from the flow rates used. - To note any potential side-effects of oxygen treatment, and if observed, determine if they occur more in either 7 L/min or 12 L/min. - To determine if the efficacy of oxygen treatment stays constant after several treated attacks. ;Primary end point(s): The main end point of the study will be the difference in VAS-scores before and after treatment. ;Timepoint(s) of evaluation of this end point: 15 minutes after start of oxygen treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint will be the percentage of attacks treated successfully. An attack treated successfully is defined as achievement of a painfree state or as a drop in VAS-score of over 50% within 15 minutes.;Timepoint(s) of evaluation of this end point: 15 minutes after start of oxygen treatment | — |
Countries
Netherlands
Contacts
Public ContactDanielle Haane
Dept. of Neurology, Atrium Medical Centre
Outcome results
None listed