Acute Unilateral Vestibulopathy and Corticosteroid Treatment
Study Details
Study Description
Brief Summary
Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).
Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects.
Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing.
Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days).
Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months.
Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Day 1: Intravenous sodium-chloride 2ml Day 2-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo |
Drug: Placebo
Placebo intravenous NaCl intravenous administration Placebo tablets
Other Names:
|
| Active Comparator: Short treatment Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo |
Drug: Betamethasone
Betamethasone intravenous
Other Names:
Drug: Prednisolone
Oral tablets
Other Names:
|
| Active Comparator: Standard treatment Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg |
Drug: Betamethasone
Betamethasone intravenous
Other Names:
Drug: Prednisolone
Oral tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Caloric function [after 3 months]
Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function
- Caloric function [1 year]
Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function
Secondary Outcome Measures
- vHIT [2-5 days after debut]
measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological
- Subjective visual vertical/horizontal [2-5 days after debut,]
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
- Covert saccades [2-5 days after debut,]
Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
- Vertigo Diary [Daily from debut and until no subjective vertigo is experienced, longest 4 weeks]
Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo
- Sleep Diary [Daily from debut and 14 days onwards (2 days after last treatment)]
Patients often experience troubled sleep when treated with corticosteroids. How much has not been assessed. The patients will assess their sleep the previous night according to a Liknert scale (1=good nights sleep, 10=hardly slept at all)
- HADS-enquiry [3 and 12 months after debut]
Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness
- VSS-enquiry [3 and 12 months after debut]
Vertigo sympton score, To assess vertigo symptoms
- DHI-enquiry [3 and 12 months after debut]
Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life
- VHQ-enquiry [3 and 12 months after debut]
Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life
- Stress hormones [At debut and 1 year]
Measurement of Plasma thyroid hormones, adrenocorticoid hormones (ACTH, Cortisone) as stress indicators in acute vertigo. Baseline will be taken 1 year after debut
- Saliva-Cortisol [At debut and up to 1 week]
Daily measurement of saliva cortisol as measurement of stress
- Adverse Events [From debut to 1 year after]
Analysis of adverse events to treatment as well as functional outcome
- Hospital stay [From debut up to 10 days]
Duration of hospital stay
- vHIT [1 year]
measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological
- Subjective visual vertical/horizontal [1 month]
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
- Subjective visual vertical/horizontal [3 months]
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
- Subjective visual vertical/horizontal [1 year]
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
- Covert saccades [3 months]
Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
- Covert saccades [1 year]
Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
- Sick-leave [debut up to 1 year]
Time needed for sick-leave
- Daily living [debut up to 1 year]
Time until daily activities are as prior to th disease
Eligibility Criteria
Criteria
Inclusion Criteria:
-
definite unilateral vestibulopathy
-
no pathological HINTS (examination criteria in acute vestibular syndrome)
-
capable of making their own decisions
Exclusion Criteria:
-
tinnitus or hearing loss with same debut as vertigo
-
history of bleeding peptic ulcer
-
glaucoma
-
pregnancy or non-acceptance to use anticonception measures during 13 days after debut
-
high blood pressure >180 systolic, 105, diastolic
-
ketoacidosis with a Base Excess >=2
-
psychic disorder (not including mild depression)
-
serious infection (neutropenia, tuberculosis)
-
chronic otitis
-
history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept OtoRhinoLaryngology | Helsingborg | Sweden | ||
| 2 | Dept. Otorhinolaryngology | Kristianstad | Sweden | ||
| 3 | Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital | Lund | Sweden | 22185 |
Sponsors and Collaborators
- Lund University
Investigators
- Principal Investigator: Fredrik Tjernström, MD, PhD, Lund University
Study Documents (Full-Text)
None provided.More Information
Publications
- VN-FT-01