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Completed

NCT Number: NCT01288781

Intracranial Pressure in Experimental Models of Headache

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.

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Key information

Conditions

High Altitude Headache Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Sport, Health and Exercise Sciences, Bangor University

Bangor, Gwynedd, LL57 2PZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetazolamide

Drug

During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.

Other names: Diamox

Lactose monohydrate

Drug

During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.

Primary outcomes

  1. Change in Optic Nerve Sheath Diameter by Ultrasonography

    Time frame: 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.

Secondary outcomes

  1. Change in High Altitude Headache by Visual Analogue Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bangor University

Other

Collaborators

  • North Wales Research Committee, UK
  • Universita di Verona

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2011
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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