Skip to content

Zuurstoftherapie met verschillende stroomsnelheden voor clusterhoofdpijnaanvallen. Een dubbelblinde, gerandomiseerde, cross-over design studie.

Oxygen treatment for cluster headache attacks at different flow rates. A double-blind, randomized, cross-over design study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23355
Enrollment
108
Registered
2013-01-14
Start date
2013-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cluster headache

Interventions

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.

Sponsors

Dept. of Neurology, Atrium Medical Centre, Heerlen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cluster headache patients of at least 18 years of age, who are naïve to oxygen treatment.

Exclusion criteria

Exclusion criteria: 1. Past oxygen use; 2. Pregnancy or lactation; 3. COPD and other contraindications for oxygen; 4. Secondary cluster headache; 5. Distracting painful conditions; 6. Incapacitation to understand and sign for informed consent; 7. Patients living outside a designated insurance zone; 8. Raise of dose of prophylactic medication in first 2 days of study.

Design outcomes

Primary

MeasureTime frame
Difference between the flow rates of 7 and 12 L/min in percentages of achievement of a painfree state after 15 minutes of treatment with oxygen, given in at least 2 attacks/day on the first 2 days.

Secondary

MeasureTime frame
Difference between the flow rates of 7 and 12 L/min in percentage of attacks treated successfully, the difference between the flow rates of 7 and 12 L/min in drop in VAS score and percentages of patients preference to the flow rates of 7 and 12 L/min, in the 4 treatment periods (i.e. day 3 till 14).

Contacts

Public ContactP.J. Koehler

Atrium medisch centrum Department of neurology PO Box 4446

p.koehler@atriummc.nl+31 (0)45-576 67 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)