Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients

NCT ID: NCT06332326

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2024-06-15

Brief Summary

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The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH).

Detailed Description

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It was planned to include 40 patients diagnosed with UHV in the study. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).

Conditions

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Vestibular Diseases Vestibular Vertigo Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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VR+VAGUS GROUP

VR+VAGUS GROUP (n=20): PATIENTS USED NON-INVASIVE VAGUS NERVE STIMULATION IN ADDITION TO VESTIBULAR REHABILITATION

Group Type EXPERIMENTAL

non-invasive vagus nerve stimulation

Intervention Type DEVICE

non-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation.

vestibular rehabilitation

Intervention Type BEHAVIORAL

vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.

VR GROUP

VR GROUP (n=20) : PATİENTS UNDERGOİNG VESTİBULAR REHABİLİTATİON

Group Type ACTIVE_COMPARATOR

vestibular rehabilitation

Intervention Type BEHAVIORAL

vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.

Interventions

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non-invasive vagus nerve stimulation

non-invasive vagus nerve stimulation: patients will receive non-invasive vagus nerve stimulation.

Intervention Type DEVICE

vestibular rehabilitation

vestibular rehabilitation: Patients will be given specially structured vestibular rehabilitation exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* He learned about unilateral peripheral vestibular hypofunction with videonystagmography
* Being able to communicate well

Exclusion Criteria

* Having cognitive impairment
* Presence of central neurological disease
* Lack of cooperation
* Previous ear surgery
* Accompanied by Benign Proxysmal Positional Vertigo
* Having acute Meniere's disease
* Finding pathology in temporal bone MRI
* Having a lower extremity disorder that prevents walking
* Evidence of central pathology in videonystagmography results
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Tugba Turk Kalkan

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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tuğba türk kalkan, MD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-10840098-772.02-4966

Identifier Type: -

Identifier Source: org_study_id

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