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Intracranial Pressure in Experimental Models of Headache

This study has been completed.
Sponsor:
Collaborators:
Research Center for Sport, Mountain and Health of Rovereto, University of Verona, Italy
North Wales Research Committee, UK
Information provided by (Responsible Party):
Bangor University
ClinicalTrials.gov Identifier:
NCT01288781
First received: January 27, 2011
Last updated: February 6, 2012
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
High Altitude Headache
 Drug: Acetazolamide
Drug: Lactose monohydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Intracranial Pressure in Experimental Models of Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Bangor University:

Primary Outcome Measures:
  • Change in Optic Nerve Sheath Diameter by Ultrasonography [ Time Frame: Optic Nerve Sheath Diameter: baseline, 24 hours. ] [ Designated as safety issue: No ]

    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 [ Time Frame: High Altitude Headache: baseline, 24 hours. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Blood Oxygen Saturation: baseline, 24 hours. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Fluid Balance: baseline, 24 hours. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Optic Nerve Sheath Diameter: baseline, 3 hours. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Optic Nerve Sheath Diameter: baseline, 12 hours. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Optic Nerve Sheath Diameter: baseline, 36 hours. ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetazolamide
Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
 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.
Other Name: Diamox
Placebo Comparator: Placebo
Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
 Drug: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288781

Locations
United Kingdom
School of Sport, Health and Exercise Sciences, Bangor University
Bangor, Gwynedd, United Kingdom, LL57 2PZ
Sponsors and Collaborators
Bangor University
Research Center for Sport, Mountain and Health of Rovereto, University of Verona, Italy
North Wales Research Committee, UK
Investigators
Principal Investigator: Justin S Lawley, BSc Bangor University
  More Information

No publications provided by Bangor University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01288781     History of Changes
Other Study ID Numbers: F002686, 2010-019520-31
Study First Received: January 27, 2011
Results First Received: November 24, 2011
Last Updated: February 6, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bangor University:
High Altitude Headache; intra-cranial pressure; hypoxia

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013