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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821155
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Dan Dupont Hougaard, Aalborg University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vestibular Neuritis Other: Vestibular rehabilitation Drug: Corticosteroid Not Applicable

Detailed Description:
Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients randomized to two different treatments:

  1. corticosteroid treatment ("prednisolone")
  2. combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Neuritis vestibularis (group 1)
Corticosteroid ("prednisolone")
 Drug: Corticosteroid
Prednisolone
Experimental: Neuritis vestibularis (group 2)
Corticosteroid ("prednisolone") + vestibular rehabilitation
 Other: Vestibular rehabilitation
Specialized physical therapy aimed at restoring balance

Drug: Corticosteroid
Prednisolone


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Former medical history with vestibular dysfunction
  2. Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
  3. Onset of symptoms 14 days before recruitment to the study
  4. Focal neurological symptoms/signs
  5. Contraindication to prednisolone treatment
  6. Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.
Contacts and Locations
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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): NCT03821155


Contacts
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Contact: Dan D Hougaard, MD 97662781 ext 0045 d.hougaard@rn.dk
Contact: Martin H Wolder, MS 30685964 ext 0045 m.wolder@rn.dk

Locations
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Denmark
Department of Otolaryngology, Head & Neck Surgery and Audiology Recruiting
Aalborg, North Denmark Region, Denmark, 9000
Contact: Dan D Hougaard, MD    4597662711 ext 0045    d.hougaard@rn.dk   
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Dan D Hougaard, MD Aalborg University Hospital
Principal Investigator: Martin H Wolder, MS Aalborg University Hospital
More Information
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Responsible Party: Dan Dupont Hougaard, MD, Assistant Professor, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03821155    
Other Study ID Numbers: 2018-166
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Dupont Hougaard, Aalborg University Hospital:
Vestibular Neuritis
SHIMP (suppressing head impulse paradigm)
SVV (subjective visual vertical)
Vestibular rehabilitation
 Prednisolone
v-HIT (video head impulse test)
Vestibular Neuronitis
Additional relevant MeSH terms:
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Vestibular Neuronitis
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases