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Double-blind, placebo-controlled crossover trial of inhaled oxygen in the treatment of acute cluster headache

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94092997
Enrollment
55
Registered
2007-06-15
Start date
2003-04-02
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Cluster headache Nervous System Diseases Cluster headache

Interventions

Treatment of acute cluster headache with inhaled air or oxygen. Each participant will be randomised to treatment sequence of either AB or BA, where A is oxygen and B is inhaled air.

Sponsors

BOC Ltd (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Active Cluster headache 2. Attack duration between 45 minutes and three hours

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women will be excluded 2. Patients with moderate to severe chronic obstructive pulmonary disease will be excluded as the high-dose high-flow oxygen may affect their hypoxic respiratory drive. 3. Patients who cannot tolerate the oxygen mask in the correct fitting will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Proportion of patients pain free after 15 minutes of treatment comparing oxygen and air.

Secondary

MeasureTime frame
1. Rendering the patient pain free at 30 minutes 2. Reduction in pain scale at 15, 30, 45 and 60 minutes 3. Need for rescue medication from 15 minutes after treatment 4. Overall response to the treatment and overall functional disability 5. Effect on associated symptoms

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026