Clinical trial NCT01288781: Intracranial Pressure in Experimental Models of Headache
Official title: Intracranial Pressure in Experimental Models of Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude Headache
Keywords: High Altitude Headache; intra-cranial pressure; hypoxia
Lead sponsor: Bangor University
Sponsor class: OTHER
Collaborators: name: Universita di Verona
name: North Wales Research Committee, UK
First posted: 2011-02-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Optic Nerve Sheath Diameter by Ultrasonography
timeFrame: Optic Nerve Sheath Diameter: baseline, 24 hours.
Secondary outcomes:
measure: Change in High Altitude Headache by Visual Analogue Scale
timeFrame: High Altitude Headache: baseline, 24 hours.
measure: Change in Blood Oxygen Saturation
timeFrame: Blood Oxygen Saturation: baseline, 24 hours.
measure: Change in Fluid Balance
timeFrame: Fluid Balance: baseline, 24 hours.
measure: Change in Optic Nerve Sheath Diameter
timeFrame: Optic Nerve Sheath Diameter: baseline, 3 hours.
measure: Change in Optic Nerve Sheath Diameter
timeFrame: Optic Nerve Sheath Diameter: baseline, 12 hours.
measure: Change in Optic Nerve Sheath Diameter
timeFrame: Optic Nerve Sheath Diameter: baseline, 36 hours.
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: School of Sport, Health and Exercise Sciences, Bangor University
state: Gwynedd
Study officials:
affiliation: Bangor University
name: Justin S Lawley, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawley JS, Oliver SJ, Mullins P, Morris D, Junglee NA, Jelleyman C, Macdonald JH. Optic nerve sheath diameter is not related to high altitude headache: a randomized controlled trial. High Alt Med Biol. 2012 Sep;13(3):193-9. doi: 10.1089/ham.2012.1019.