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Intracranial Pressure in Experimental Models of Headache

Primary Purpose

High Altitude Headache

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acetazolamide
Lactose monohydrate
Sponsored by
Bangor University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for High Altitude Headache focused on measuring High Altitude Headache; intra-cranial pressure; hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Sport, Health and Exercise Sciences, Bangor University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm Description

Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).

Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 27, 2011
Last Updated
February 6, 2012
Sponsor
Bangor University
Collaborators
Universita di Verona, North Wales Research Committee, UK
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1. Study Identification

Unique Protocol Identification Number
NCT01288781
Brief Title
Intracranial Pressure in Experimental Models of Headache
Official Title
Intracranial Pressure in Experimental Models of Headache
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bangor University
Collaborators
Universita di Verona, North Wales Research Committee, UK

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Headache
Keywords
High Altitude Headache; intra-cranial pressure; hypoxia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
Intervention Type
Drug
Intervention Name(s)
Lactose monohydrate
Intervention Description
During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
Primary Outcome Measure Information:
Title
Change in Optic Nerve Sheath Diameter by Ultrasonography
Description
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.
Time Frame
Optic Nerve Sheath Diameter: baseline, 24 hours.
Secondary Outcome Measure Information:
Title
Change in High Altitude Headache by Visual Analogue Scale
Description
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.
Time Frame
High Altitude Headache: baseline, 24 hours.
Title
Change in Blood Oxygen Saturation
Description
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.
Time Frame
Blood Oxygen Saturation: baseline, 24 hours.
Title
Change in Fluid Balance
Description
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.
Time Frame
Fluid Balance: baseline, 24 hours.
Title
Change in Optic Nerve Sheath Diameter
Description
Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.
Time Frame
Optic Nerve Sheath Diameter: baseline, 3 hours.
Title
Change in Optic Nerve Sheath Diameter
Description
Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.
Time Frame
Optic Nerve Sheath Diameter: baseline, 12 hours.
Title
Change in Optic Nerve Sheath Diameter
Description
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.
Time Frame
Optic Nerve Sheath Diameter: baseline, 36 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin S Lawley, BSc
Organizational Affiliation
Bangor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Sport, Health and Exercise Sciences, Bangor University
City
Bangor
State/Province
Gwynedd
ZIP/Postal Code
LL57 2PZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22994519
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.
Results Reference
derived

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Intracranial Pressure in Experimental Models of Headache

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