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OpenTrials
Completed

NCT Number: NCT03821155

Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?

To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

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Key information

Conditions

Vestibular Neuritis Cranial Nerve Diseases Ear Diseases Nervous System Diseases Otorhinolaryngologic Diseases Retrocochlear Diseases Vestibular Neuronitis Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

About this study

Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years of age
  • Medical history compatible with vestibular neuritis
  • Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.

Exclusion criteria

  • Former medical history with vestibular dysfunction
  • Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
  • Onset of symptoms 14 days before recruitment to the study
  • Focal neurological symptoms/signs
  • Contraindication to prednisolone treatment
  • Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.

Treatment and study plan

Vestibular Rehabilitation

Other

Specialized physical therapy aimed at restoring balance

Corticosteroid

Drug

Prednisolone

Primary outcomes

  1. Suppressing head impulse paradigm (SHIMP)

    Time frame: 6 month

    SHIMP equipment will objectively quantify change of vestibular function.

  2. Subjective visual vertical (SVV)

    Time frame: 6 month

    SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function

  3. Video head impulse test (v-HIT)

    Time frame: 6 month

    v-HIT equipment will objectively quantify change of vestibular function.

  4. Dizziness handicap inventory (DHI) questionnaire

    Time frame: 6 month

    Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 29, 2019
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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