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N/A Completed N=23 Randomized Quadruple-blind Basic Science

Intracranial Pressure in Experimental Models of Headache

High Altitude Headache
Source: ClinicalTrials.gov NCT01288781 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Change in Optic Nerve Sheath Diameter by Ultrasonography — 0.02; 0.02 mm — p=0.98

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Optic Nerve Sheath Diameter by Ultrasonography
0.02; 0.02 0.98
SECONDARY
Change in High Altitude Headache by Visual Analogue Scale
6.4; 7.2 0.63
SECONDARY
Change in Blood Oxygen Saturation
10.8; 11.1 0.20
SECONDARY
Change in Fluid Balance
342; 147 <0.01 sig
SECONDARY
Change in Optic Nerve Sheath Diameter
0.01; 0.00 0.98

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01288781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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