Primary: 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: - Identifying subgroups in which oxygen at flow rates of 7 L/…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the difference in VAS score before and after oxygen
treatment.
Secondary outcome
The secondary endpoint is the percentage of successfully treated attacks as
defined by a drop in VAS score of over 50% within 15 minutes.
Background summary
Oxygen is frequently used as an acute attack treatment for cluster headache.
Studies have showed the beneficial effect of oxygen compared to placebo at flow
rates of 7 L/min and 12 L/min. Three patients who did not respond to 7-10 L/min
but did so to 14-15 L/min were described in a case report. The difference in
effect between 7 L/min and 12 L/min, however, has never been investigated in a
controlled study. This might aid the clinician in making an appropriate
decision when prescribing oxygen.
Study objective
Primary:
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:
- 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.
Study design
Double-blind cross-over design study, in which every patient will treat his
attacks with either oxygen at 7 L/min or 12 L/min for a total of 4 time
periods, each lasting 3 days. There will be no set amount of attacks to be
treated in each time period.
Intervention
Patients will be crossed-over between treatment with oxygen at a flow rate of 7
L/min and 12 L/min. Treatment will be continued until the cluster headache
attack has ended or for 15 minutes.
Study burden and risks
Patients will have to fill in two questionnaires: one before and one after the
study. During the treatment they will have to fill in a diary to describe the
effect of the various treatments. A possible side-effect of oxygen usage is
dyspnea caused by hypoventilation or atelectasis.
Furthermore heart rate and cardiac output might be reduced when 100 % oxygen is
administered for short periods (< 6 hours) under normobaric conditions. In
patients who are dependent of oxygen as a stimulus for breathing (COPD
patients), oxygen treatment might lead to acidosis.
Further side effects have only been described in continuous oxygen usage.
As oxygen entails a fire hazard, patient will be adequately informed in the
usual way by the oxygen supplier.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
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.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003648-59-NL |
| CCMO | NL41818.096.12 |