Intracranial Pressure in Experimental Models of Headache

High Altitude Headache Clinical Trial

Official title:

Intracranial Pressure in Experimental Models of Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288781
• Other study ID #: F002686
• Secondary ID: 2010-019520-31
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: February 6, 2012
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Bangor University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Headache
• High Altitude Headache

Intervention

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

Locations

Country	Name	City	State
United Kingdom	School of Sport, Health and Exercise Sciences, Bangor University	Bangor	Gwynedd

Sponsors (3)

Lead Sponsor	Collaborator
Bangor University	North Wales Research Committee, UK, Universita di Verona

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Optic Nerve Sheath Diameter by Ultrasonography	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.	Optic Nerve Sheath Diameter: baseline, 24 hours.	No
Secondary	Change in High Altitude Headache by Visual Analogue Scale	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.	High Altitude Headache: baseline, 24 hours.	No
Secondary	Change in Blood Oxygen Saturation	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.	Blood Oxygen Saturation: baseline, 24 hours.	No
Secondary	Change in Fluid Balance	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.	Fluid Balance: baseline, 24 hours.	No
Secondary	Change in Optic Nerve Sheath Diameter	Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.	Optic Nerve Sheath Diameter: baseline, 3 hours.	No
Secondary	Change in Optic Nerve Sheath Diameter	Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.	Optic Nerve Sheath Diameter: baseline, 12 hours.	No
Secondary	Change in Optic Nerve Sheath Diameter	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.	Optic Nerve Sheath Diameter: baseline, 36 hours.	No