NCT01288781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
5 months until next milestone

Results Posted

Study results publicly available

December 26, 2011

Completed
Last Updated

February 7, 2012

Status Verified

December 1, 2011

Enrollment Period

1 month

First QC Date

January 27, 2011

Results QC Date

November 24, 2011

Last Update Submit

February 6, 2012

Conditions

High Altitude Headache

Keywords

High Altitude Headache; intra-cranial pressure; hypoxia

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (6)

  • Change in High Altitude Headache by Visual Analogue Scale

    High Altitude Headache: baseline, 24 hours.

  • Change in Blood Oxygen Saturation

    Blood Oxygen Saturation: baseline, 24 hours.

  • Change in Fluid Balance

    Fluid Balance: baseline, 24 hours.

  • Change in Optic Nerve Sheath Diameter

    Optic Nerve Sheath Diameter: baseline, 3 hours.

  • Change in Optic Nerve Sheath Diameter

    Optic Nerve Sheath Diameter: baseline, 12 hours.

  • +1 more secondary outcomes

Study Arms (2)

Acetazolamide

EXPERIMENTAL

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

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

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

Drug: Lactose monohydrate

Interventions

AcetazolamideDRUG

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

Also known as: Diamox
Acetazolamide
Lactose monohydrateDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of the Italian High Altitude Research Expeditions

You may not qualify if:

  • Are under the age of 18years;
  • sulfonamide allergy
  • Liver or kidney disfunction
  • Have any other uncontrolled medical condition
  • Or are unable to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport, Health and Exercise Sciences, Bangor University

Bangor, Gwynedd, LL57 2PZ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22994519DERIVED

MeSH Terms

Conditions

Hypoxia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Acetazolamide did not reduce high altitude headache as expected. Nevertheless the relationship between optic nerve sheath diameter and headache could still be determined by completing other analyses.

Results Point of Contact

Title
Mr Justin Stevan Lawley
Organization
UWalesBangor
pepa16@bangor.ac.uk
00441248382810

Study Officials

  • Justin S Lawley, BSc

    Bangor University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 2, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 7, 2012

Results First Posted

December 26, 2011

Record last verified: 2011-12

Locations

GB(1)