High Altitude HeadacheNCT01288781
Intracranial Pressure in Experimental Models of Headache
A study testing Acetazolamide and Lactose monohydrate in people with High Altitude Headache, run by Bangor University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Altitude Headache
- What is being tested?
- Acetazolamide and Lactose monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Member of the Italian High Altitude Research Expeditions
Who cannot join
- Are under the age of 18years;
- sulfonamide allergy
- Liver or kidney disfunction
- Have any other uncontrolled medical condition
- Or are unable to give consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Health and Exercise Sciences, Bangor University
Bangor, Gwynedd, LL57 2PZ
About this study
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.
Read the 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.
- Conditions
- High Altitude Headache
- Being tested
- Acetazolamide, Lactose monohydrate
- Keywords
- High Altitude Headache; intra-cranial pressure; hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
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.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). Receives: Drug: Lactose monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Optic Nerve Sheath Diameter: baseline, 24 hours.
Secondary outcomes (6)
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.
Measured: High Altitude Headache: baseline, 24 hours.
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.
Measured: Blood Oxygen Saturation: baseline, 24 hours.
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.
Measured: Fluid Balance: baseline, 24 hours.
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.
Measured: Optic Nerve Sheath Diameter: baseline, 3 hours.
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.
Measured: Optic Nerve Sheath Diameter: baseline, 12 hours.
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.
Measured: Optic Nerve Sheath Diameter: baseline, 36 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Altitude HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona, North Wales Research Committee, UK
- Responsible party
- Sponsor
- Investigators
- Justin S Lawley, BSc, Principal investigator, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288781
- Sponsor's protocol ID
- F002686
- Other IDs
- 2010-019520-31
- Status last verified
- Dec 2011
- First submitted
- 27 Jan 2011
- Last updated
- 7 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22994519
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Pressure in Experimental Models of Headache
- ClinicalTrials.gov ID
- NCT01288781
- Acronym / sponsor ID
- F002686
- Conditions
- High Altitude Headache
- Keywords
- High Altitude Headache; intra-cranial pressure; hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Collaborators
- Universita di Verona, North Wales Research Committee, UK
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Posted 26 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideArm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
| Placebo | Placebo comparator | Drug: Lactose monohydratePlacebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Member of the Italian High Altitude Research Expeditions
Key exclusion criteria (5 listed)
- Are under the age of 18years;
- sulfonamide allergy
- Liver or kidney disfunction
- Have any other uncontrolled medical condition
- Or are unable to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: DiamoxDuring a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two. | Drug | Acetazolamide |
| Lactose monohydrateDuring a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two. | Drug | Placebo |
Primary outcome
Change in Optic Nerve Sheath Diameter by Ultrasonography
Time frame: Optic Nerve Sheath Diameter: baseline, 24 hours.
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.
6 secondary outcomes
Change in High Altitude Headache by Visual Analogue Scale
Time frame: High Altitude Headache: baseline, 24 hours.
Change in Blood Oxygen Saturation
Time frame: Blood Oxygen Saturation: baseline, 24 hours.
Change in Fluid Balance
Time frame: Fluid Balance: baseline, 24 hours.
Change in Optic Nerve Sheath Diameter
Time frame: Optic Nerve Sheath Diameter: baseline, 3 hours.
Change in Optic Nerve Sheath Diameter
Time frame: Optic Nerve Sheath Diameter: baseline, 12 hours.
Change in Optic Nerve Sheath Diameter
Time frame: Optic Nerve Sheath Diameter: baseline, 36 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22994519Lawley 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin S Lawley, BSc principal investigator
Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetazolamide and Lactose monohydrate in people with High Altitude Headache, run by Bangor University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optic Nerve Sheath Diameter by Ultrasonography (time frame: Optic Nerve Sheath Diameter: baseline, 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.