Trial · NCT01288781
Intracranial Pressure in Experimental Models of Headache
NCT01288781, Not applicable, Completed, Bangor University; results first posted 2011-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intracranial Pressure in Experimental Models of Headache. Trials, record NCT01288781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01288781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intracranial Pressure in Experimental Models of Headache
- NCT number
- NCT01288781
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 23 participants, actual
- Lead sponsor
- Bangor University
- Conditions
- High Altitude Headache
- Interventions
- Acetazolamide, Lactose monohydrate
- First posted
- 2011-02-02
- Last updated
- 2012-02-07
- Other registries' IDs
- eudract:2010-019520-31
- Results first posted
- 2011-12-26
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Optic Nerve Sheath Diameter by Ultrasonography | 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. |
| Secondary | Change in High Altitude Headache by Visual Analogue Scale | High Altitude Headache: 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. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache. |
| Secondary | Change in Blood Oxygen Saturation | Blood Oxygen Saturation: 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. |
| Secondary | Change in Fluid Balance | Fluid Balance: 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. 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. |
| Secondary | Change in Optic Nerve Sheath Diameter | Optic Nerve Sheath Diameter: baseline, 3 hours. | Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement. |
| Secondary | Change in Optic Nerve Sheath Diameter | Optic Nerve Sheath Diameter: baseline, 12 hours. | Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement. |
| Secondary | Change in Optic Nerve Sheath Diameter | Optic Nerve Sheath Diameter: baseline, 36 hours. | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Optic Nerve Sheath Diameter by Ultrasonography | Optic Nerve Sheath Diameter: baseline, 24 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | mm | MEAN |
| SECONDARY | Change in High Altitude Headache by Visual Analogue Scale | High Altitude Headache: baseline, 24 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | mm | MEAN |
| SECONDARY | Change in Blood Oxygen Saturation | Blood Oxygen Saturation: baseline, 24 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | % oxygen saturation | MEAN |
| SECONDARY | Change in Fluid Balance | Fluid Balance: baseline, 24 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | % of fluid intake | MEAN |
| SECONDARY | Change in Optic Nerve Sheath Diameter | Optic Nerve Sheath Diameter: baseline, 3 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | mm | MEAN |
| SECONDARY | Change in Optic Nerve Sheath Diameter | Optic Nerve Sheath Diameter: baseline, 12 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | mm | MEAN |
| SECONDARY | Change in Optic Nerve Sheath Diameter | Optic Nerve Sheath Diameter: baseline, 36 hours. | All participants were included. Analysis was intention to treat. There were no missing data. | mm | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Optic Nerve Sheath Diameter by Ultrasonography | Acetazolamide | 0.02 | Standard Deviation 0.06 | mm | |
| Change in Optic Nerve Sheath Diameter by Ultrasonography | Placebo | 0.02 | Standard Deviation 0.06 | mm | |
| Change in High Altitude Headache by Visual Analogue Scale | Acetazolamide | 6.4 | Standard Deviation 10.5 | mm | |
| Change in High Altitude Headache by Visual Analogue Scale | Placebo | 7.2 | Standard Deviation 10.5 | mm | |
| Change in Blood Oxygen Saturation | Acetazolamide | 10.8 | Standard Deviation 4.3 | % oxygen saturation | |
| Change in Blood Oxygen Saturation | Placebo | 11.1 | Standard Deviation 4.3 | % oxygen saturation | |
| Change in Fluid Balance | Acetazolamide | 342 | Standard Deviation 109 | % of fluid intake | |
| Change in Fluid Balance | Placebo | 147 | Standard Deviation 85 | % of fluid intake | |
| Change in Optic Nerve Sheath Diameter | Acetazolamide | 0.00 | Standard Deviation 0.06 | mm | |
| Change in Optic Nerve Sheath Diameter | Placebo | -0.01 | Standard Deviation 0.06 | mm |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acetazolamide | 11 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Acetazolamide | 11 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Acetazolamide | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acetazolamide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Acetazolamide | 0 | 11 |
| Total, other adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Acetazolamide | 0 | 11 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22994519 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Acetazolamide vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01288781
GET https://conductscience.org/api/trials/v1/NCT01288781/registered