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Intracranial Pressure in Experimental Models of Headache

Not Applicable
Completed
Conditions
High Altitude Headache
Interventions
Registration Number
NCT01288781
Lead Sponsor
Bangor University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboLactose monohydratePlacebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
AcetazolamideAcetazolamideArm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Primary Outcome Measures
NameTimeMethod
Change in Optic Nerve Sheath Diameter by UltrasonographyOptic 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.

Secondary Outcome Measures
NameTimeMethod
Change in Fluid BalanceFluid 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.

Change in High Altitude Headache by Visual Analogue ScaleHigh 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.

Change in Blood Oxygen SaturationBlood 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.

Change in Optic Nerve Sheath DiameterOptic 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.

Trial Locations

Locations (1)

School of Sport, Health and Exercise Sciences, Bangor University

🇬🇧

Bangor, Gwynedd, United Kingdom

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