Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019520-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universita di Verona | OTHER |
| North Wales Research Committee, UK | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Experimental | Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
|
| Placebo | Placebo Comparator | Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Justin S Lawley, BSc | Bangor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Sport, Health and Exercise Sciences, Bangor University | Bangor | Gwynedd | LL57 2PZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22994519 | Derived | 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. |
Not provided
Not provided
Participants completed two trials, including a 12 hour sea level exposure followed by a 36 hour high altitude exposure (3777m). Participants were assigned to one of two groups based on High-altitude headache susceptibility determined by visual analogue score obtained after 12 hours at high altitude. No participants were excluded.
Participants attending the Antur Ymchwil 2011 Expedition to the European Alps were recruited between 01.07.11 and 01.08.11.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acetazolamide | Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
| FG001 | Placebo | Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acetazolamide | Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
| BG001 | Placebo | Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | mm | Optic Nerve Sheath Diameter: baseline, 24 hours. |
|
Study data collection period only (baseline and high altitude exposures up to 36 hours).
Adverse events recorded by study investigators at six hourly interviews.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetazolamide | Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Justin Stevan Lawley | UWalesBangor | 00441248382810 | pepa16@bangor.ac.uk |
Not provided
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lactose monohydrate | Drug | During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two. |
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). |
|
|
|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | mm | High Altitude Headache: baseline, 24 hours. |
|
|
|
|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | % oxygen saturation | Blood Oxygen Saturation: baseline, 24 hours. |
|
|
|
|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | % of fluid intake | Fluid Balance: baseline, 24 hours. |
|
|
|
|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | mm | Optic Nerve Sheath Diameter: baseline, 3 hours. |
|
|
|
|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | mm | Optic Nerve Sheath Diameter: baseline, 12 hours. |
|
|
|
|
| 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. | All participants were included. Analysis was intention to treat. There were no missing data. | Posted | Mean | Standard Deviation | mm | Optic Nerve Sheath Diameter: baseline, 36 hours. |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point. | t-test, 2 sided | <0.01 | Step down Holm Bonferroni correction was applied | 95 | No | Superiority or Other |