A Phase 4 interventional study of Prednisone in Acute Peripheral Vestibulopathy, sponsored by University Hospital, Geneva. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by University Hospital, Geneva · Phase 4, Interventional, and Treatment
The vestibular system is a part of the inner ear and functions as a motion sensor. It provides the central nervous system with information about changes of the head position. This information is essential for the proper functioning of the balance system. In particular, it ensures effective postural control and gaze stabilization. Abrupt vestibular deficit is defined as a sudden loss of the vestibular function. In the acute phase the patient presents mainly with intense rotatory vertigo and instability, most often accompanied by nausea. The symptoms are exacerbated by head movements. The diagnosis is made by observation of a spontaneous nystagmus, measurement of a pathological head impulse test and an asymmetric response to caloric tests, in the absence of other neurological symptoms. Although the etiology is unknown, it could be of viral or vascular origin. Symptoms usually regress within a few days or weeks. Vestibular function recovers in about half of the cases, in the other half a central compensation process is set up. The benefit of a 3-week course of corticosteroids has been demonstrated in one study. The dosage has been debated. The aim of this study is to demonstrate the benefit of a 10-day course of oral corticosteroids. The primary objective is to demonstrate a significant reduction in the rate of asymmetry of caloric response and the secondary objective is to demonstrate a significant reduction in the impact of symptoms assessed with the Dizziness Handicap Inventory (DHI) score at 1 year.
34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.
This study's enrollment of 96 is above the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.
Browse Vestibular Neuronitis studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
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Medical History :
Physical examination :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Prednisone, 60mg/d, for 10 days
Drug: Prednisone
Drug: Prednisone
oral administration, 60mg/d for 10d
Bithermal calorics asymetry
Time frame: Day 1
Bithermal calorics asymetry
Time frame: Day 21
Bithermal calorics asymetry
Time frame: Day 365
Dizziness Hanidcap Inventory (Questionnaire)
min: 0 / max:100, higher score is worse
Time frame: Day 1, Day 21, Day 365
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prednisone