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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Peter Goadsby
Scientific

Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Primary study design	Interventional
Study design	Double-blind, placebo-controlled, cross-over randomised trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CHAO2
Study objectives	Oxygen is a more effective treatment of acute cluster headache than air.
Ethics approval(s)	The National Hospital for Neurology and Neurosurgery, approved on 3 March 2003 (ref: 01/N122)
Health condition(s) or problem(s) studied	Cluster headache
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Proportion of patients pain free after 15 minutes of treatment comparing oxygen and air.
Key secondary outcome measure(s)	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
Completion date	30/04/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	55
Key inclusion criteria	1. Active Cluster headache 2. Attack duration between 45 minutes and three hours
Key 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
Date of first enrolment	02/04/2003
Date of final enrolment	30/04/2007

Institute of Neurology

London
WC1N 3BG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/12/2009		Yes	No