Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Vestibular Diseases Clinical Trial

Official title:

Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02912182
• Other study ID #: VN-FT-01
• Status: Terminated
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Neuronitis

Intervention

Drug:
• Betamethasone
Betamethasone intravenous
• Placebo
Placebo intravenous NaCl intravenous administration Placebo tablets
• Prednisolone
Oral tablets

Locations

Country	Name	City	State
Sweden	Dept OtoRhinoLaryngology	Helsingborg
Sweden	Dept. Otorhinolaryngology	Kristianstad
Sweden	Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Fishman JM, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev. 2011 May 11;(5):CD008607. doi: 10.1002/14651858.CD008607.pub2. Review. — View Citation

Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caloric function	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	after 3 months
Primary	Caloric function	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	1 year
Secondary	vHIT	measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological	2-5 days after debut
Secondary	Subjective visual vertical/horizontal	Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation	2-5 days after debut,
Secondary	Covert saccades	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	2-5 days after debut,
Secondary	Vertigo Diary	Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo	Daily from debut and until no subjective vertigo is experienced, longest 4 weeks
Secondary	Sleep Diary	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)	Daily from debut and 14 days onwards (2 days after last treatment)
Secondary	HADS-enquiry	Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness	3 and 12 months after debut
Secondary	VSS-enquiry	Vertigo sympton score, To assess vertigo symptoms	3 and 12 months after debut
Secondary	DHI-enquiry	Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life	3 and 12 months after debut
Secondary	VHQ-enquiry	Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life	3 and 12 months after debut
Secondary	Stress hormones	Measurement of Plasma thyroid hormones, adrenocorticoid hormones (ACTH, Cortisone) as stress indicators in acute vertigo. Baseline will be taken 1 year after debut	At debut and 1 year
Secondary	Saliva-Cortisol	Daily measurement of saliva cortisol as measurement of stress	At debut and up to 1 week
Secondary	Adverse Events	Analysis of adverse events to treatment as well as functional outcome	From debut to 1 year after
Secondary	Hospital stay	Duration of hospital stay	From debut up to 10 days
Secondary	vHIT	measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological	1 year
Secondary	Subjective visual vertical/horizontal	Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation	1 month
Secondary	Subjective visual vertical/horizontal	Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation	3 months
Secondary	Subjective visual vertical/horizontal	Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation	1 year
Secondary	Covert saccades	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	3 months
Secondary	Covert saccades	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	1 year
Secondary	Sick-leave	Time needed for sick-leave	debut up to 1 year
Secondary	Daily living	Time until daily activities are as prior to th disease	debut up to 1 year