Intracranial Pressure in Experimental Models of Headache

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Sponsorii

Bangor University

Colaboratori

Universita di Verona

North Wales Research Committee, UK

STUDIU CLINIC: NCT01288781

BioSeek: NCT01288781

Cuvinte cheie

Abstract

The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.

Descriere

High Altitude Headache is the primary symptom of Acute Mountain Sickness. However, at present the reason why some individuals suffer from High Altitude Headache and others do not remains unknown. It is widely believed that elevated pressure within the brain leads to stretching of pain sensitive fibres and thus headache. However, evidence of raised intracranial pressure during High Altitude Headache is currently unavailable. Therefore, this study aims to examine a proxy measure of intracranial pressure (Optic Nerve Sheath Diameter) in persons visiting High Altitude, half of whom have been given the drug acetazolamide that is known to reduce headache symptoms.

Datele

Ultima verificare:	11/30/2011
Primul depus:	01/26/2011
Inscriere estimată trimisă:	01/30/2011
Prima postare:	02/01/2011
Ultima actualizare trimisă:	02/05/2012
Ultima actualizare postată:	02/06/2012
Data primelor rezultate transmise:	11/23/2011
Data primelor rezultate QC trimise:	11/23/2011
Data primelor rezultate postate:	12/25/2011
Data actuală de începere a studiului:	06/30/2011
Data estimată de finalizare primară:	07/31/2011
Data estimată de finalizare a studiului:	07/31/2011

Stare sau boală

High Altitude Headache

Intervenție / tratament

Drug: Acetazolamide

Drug: Placebo

Fază

Grupuri de brațe

Braţ	Intervenție / tratament
Experimental: Acetazolamide Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Drug: Acetazolamide During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
Placebo Comparator: Placebo Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Drug: Placebo During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.

Criterii de eligibilitate

Vârste eligibile pentru studiu	18 Years La 18 Years
Sexe eligibile pentru studiu	All
Acceptă voluntari sănătoși	da
Criterii	Inclusion Criteria: - Member of the Italian High Altitude Research Expeditions Exclusion Criteria: - Are under the age of 18years; - sulfonamide allergy - Liver or kidney disfunction - Have any other uncontrolled medical condition - Or are unable to give consent.

Rezultat

Măsuri de rezultate primare

1. Change in Optic Nerve Sheath Diameter by Ultrasonography [Optic Nerve Sheath Diameter: baseline, 24 hours.]

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure.

Măsuri de rezultate secundare

1. Change in High Altitude Headache by Visual Analogue Scale [High Altitude Headache: baseline, 24 hours.]

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache.

2. Change in Blood Oxygen Saturation [Blood Oxygen Saturation: baseline, 24 hours.]

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement.

3. Change in Fluid Balance [Fluid Balance: baseline, 24 hours.]

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Urine output was recorded by 24 hour urine collection and fluid intake by 24 hour food diaries. Fluid balance was calculated as: (urine output (L) / fluid intake (L) ) * 100.

4. Change in Optic Nerve Sheath Diameter [Optic Nerve Sheath Diameter: baseline, 3 hours.]

Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.

5. Change in Optic Nerve Sheath Diameter [Optic Nerve Sheath Diameter: baseline, 12 hours.]

Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.

6. Change in Optic Nerve Sheath Diameter [Optic Nerve Sheath Diameter: baseline, 36 hours.]

Baseline is defined as the average of the 3 hour and 12 hour normoxia measurements. 36 hours is defined at the 36 hour hypoxia measurement.