Intracranial Pressure in Experimental Models of Headache

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DurumTamamlandı

Sponsorlar

Bangor University

Ortak çalışanlar

Universita di Verona

North Wales Research Committee, UK

KLINIK ÇALIŞMA: NCT01288781

BioSeek: NCT01288781

Anahtar kelimeler

Öz

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.

Açıklama

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.

Tarih

Son Doğrulandı:	11/30/2011
İlk Gönderilen:	01/26/2011
Tahmini Kayıt Gönderildi:	01/30/2011
İlk Gönderilen:	02/01/2011
Son Güncelleme Gönderildi:	02/05/2012
Son Güncelleme Gönderildi:	02/06/2012
İlk gönderilen sonuçların tarihi:	11/23/2011
QC sonuçlarının ilk gönderildiği tarih:	11/23/2011
İlk yayınlanan sonuçların tarihi:	12/25/2011
Fiili Çalışma Başlangıç Tarihi:	06/30/2011
Tahmini Birincil Tamamlanma Tarihi:	07/31/2011
Tahmini Çalışma Tamamlanma Tarihi:	07/31/2011

Durum veya hastalık

High Altitude Headache

Müdahale / tedavi

Drug: Acetazolamide

Drug: Placebo

Evre

Kol Grupları

Kol	Müdahale / tedavi
Experimental: Acetazolamide Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Drug: Acetazolamide During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
Placebo Comparator: Placebo Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).	Drug: Placebo During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.

Uygunluk kriterleri

Çalışmaya Uygun Yaşlar	18 Years İçin 18 Years
Çalışmaya Uygun Cinsiyetler	All
Sağlıklı Gönüllüleri Kabul Ediyor	Evet
Kriterler	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.

Sonuç

Birincil Sonuç Ölçütleri

1. 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.

İkincil Sonuç Ölçütleri

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.