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Acute Unilateral Vestibulopathy and Corticosteroid Treatment

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ClinicalTrials.gov Identifier: NCT02912182
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Lund University

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
Vestibular Diseases Vestibular Neuronitis Drug: Betamethasone Drug: Placebo Drug: Prednisolone 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Unilateral Vestibulopathy and Corticosteroid Treatment
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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 Name: Sodiumchloride

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 Name: Betapred

Drug: Prednisolone
Oral tablets
Other Name: Prednisolon

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 Name: Betapred

Drug: Prednisolone
Oral tablets
Other Name: Prednisolon




Primary Outcome Measures :
  1. Caloric function [ Time Frame: 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

  2. Caloric function [ Time Frame: 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 :
  1. vHIT [ Time Frame: 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

  2. Subjective visual vertical/horizontal [ Time Frame: 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

  3. Covert saccades [ Time Frame: 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

  4. Vertigo Diary [ Time Frame: 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

  5. Sleep Diary [ Time Frame: 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)

  6. HADS-enquiry [ Time Frame: 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

  7. VSS-enquiry [ Time Frame: 3 and 12 months after debut ]
    Vertigo sympton score, To assess vertigo symptoms

  8. DHI-enquiry [ Time Frame: 3 and 12 months after debut ]
    Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life

  9. VHQ-enquiry [ Time Frame: 3 and 12 months after debut ]
    Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life

  10. Stress hormones [ Time Frame: 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

  11. Saliva-Cortisol [ Time Frame: At debut and up to 1 week ]
    Daily measurement of saliva cortisol as measurement of stress

  12. Adverse Events [ Time Frame: From debut to 1 year after ]
    Analysis of adverse events to treatment as well as functional outcome

  13. Hospital stay [ Time Frame: From debut up to 10 days ]
    Duration of hospital stay

  14. vHIT [ Time Frame: 1 year ]
    measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological

  15. Subjective visual vertical/horizontal [ Time Frame: 1 month ]
    Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

  16. Subjective visual vertical/horizontal [ Time Frame: 3 months ]
    Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

  17. Subjective visual vertical/horizontal [ Time Frame: 1 year ]
    Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation

  18. Covert saccades [ Time Frame: 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

  19. Covert saccades [ Time Frame: 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

  20. Sick-leave [ Time Frame: debut up to 1 year ]
    Time needed for sick-leave

  21. Daily living [ Time Frame: debut up to 1 year ]
    Time until daily activities are as prior to th disease



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912182


Contacts
Contact: Fredrik Tjernström, MD, PhD +46 46 175849 Fredrik.Tjernstrom@med.lu.se
Contact: Måns Magnusson, MD, PhD +46 46 171796 Mans.Magnusson@med.lu.se

Locations
Sweden
Dept OtoRhinoLaryngology Recruiting
Helsingborg, Sweden
Contact: Kornel Sass, MD, PhD    +4642 4061000    Kornel.Sass@skane.se   
Dept. Otorhinolaryngology Recruiting
Kristianstad, Sweden
Contact: Sergio Padoan, MD, PhD    +4644-309 10 00    Sergio.Padoan@skane.se   
Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital Recruiting
Lund, Sweden, 22185
Contact: Fredrik Tjernström, MD, PhD    +4646 175849    fredrik.tjernstrom@med.lu.se   
Contact: Måns Magnusson, MD, PhD    +4646 171796    mans.Magnusson@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Fredrik Tjernström, MD, PhD Lund University

Publications of Results:
Other Publications:
Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT02912182     History of Changes
Other Study ID Numbers: VN-FT-01
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vestibular Diseases
Vestibular Neuronitis
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Cranial Nerve Diseases
Nervous System Diseases
Prednisolone acetate
Methylprednisolone acetate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Betamethasone
Betamethasone Valerate
Prednisolone hemisuccinate
Prednisolone phosphate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents