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

Primary Purpose

Vestibular Neuritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vestibular rehabilitation
Corticosteroid
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Neuritis focused on measuring Vestibular Neuritis, SHIMP (suppressing head impulse paradigm), SVV (subjective visual vertical), Vestibular rehabilitation, Prednisolone, v-HIT (video head impulse test), Vestibular Neuronitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Otolaryngology, Head & Neck Surgery and Audiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Neuritis vestibularis (group 1)

Neuritis vestibularis (group 2)

Arm Description

Corticosteroid ("prednisolone")

Corticosteroid ("prednisolone") + vestibular rehabilitation

Outcomes

Primary Outcome Measures

Suppressing head impulse paradigm (SHIMP)
SHIMP equipment will objectively quantify change of vestibular function.
Subjective visual vertical (SVV)
SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function
Video head impulse test (v-HIT)
v-HIT equipment will objectively quantify change of vestibular function.
Dizziness handicap inventory (DHI) questionnaire
Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2019
Last Updated
July 28, 2022
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03821155
Brief Title
Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?
Official Title
Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Neuritis
Keywords
Vestibular Neuritis, SHIMP (suppressing head impulse paradigm), SVV (subjective visual vertical), Vestibular rehabilitation, Prednisolone, v-HIT (video head impulse test), Vestibular Neuronitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized to two different treatments: corticosteroid treatment ("prednisolone") combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuritis vestibularis (group 1)
Arm Type
Active Comparator
Arm Description
Corticosteroid ("prednisolone")
Arm Title
Neuritis vestibularis (group 2)
Arm Type
Experimental
Arm Description
Corticosteroid ("prednisolone") + vestibular rehabilitation
Intervention Type
Other
Intervention Name(s)
Vestibular rehabilitation
Intervention Description
Specialized physical therapy aimed at restoring balance
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
Prednisolone
Primary Outcome Measure Information:
Title
Suppressing head impulse paradigm (SHIMP)
Description
SHIMP equipment will objectively quantify change of vestibular function.
Time Frame
6 month
Title
Subjective visual vertical (SVV)
Description
SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function
Time Frame
6 month
Title
Video head impulse test (v-HIT)
Description
v-HIT equipment will objectively quantify change of vestibular function.
Time Frame
6 month
Title
Dizziness handicap inventory (DHI) questionnaire
Description
Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan D Hougaard, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin H Wolder, MS
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Head & Neck Surgery and Audiology
City
Aalborg
State/Province
North Denmark Region
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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