Association Between Severe-to-profound Hearing Loss and the Balance Function of the Inner Ear

NCT05500521 | Completed

• 1 other identifier: Hearing-vestibular
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Severe-to-profound hearing loss can have a major impact on patients´ lives leading to social isolation and decreased quality of life. Most commonly the hearing loss is caused by damage to the inner ear or cochlear nerve. Since the vestibular system which is central for our balance is located in the inner ear it can be suspected that patients with severe-to-profound hearing loss also might have an impaired vestibular function. This impairment may lead to a feeling of dizziness or vertigo. This study aims to investigate if patients with severe-to-profound hearing loss also have impaired vestibular function. The vestibular function will be measured with caloric irrigation, video head impulse test and vestibular evoked myogenic potential.

Conditions

Hearing Loss, Sensorineural, Severe; Hearing Loss, Sensorineural, Profound; Vestibular Disorder

Keywords

hearing loss; vestibular function; video head impulse test; VEMP; caloric irrigation; dizziness

Outcome Measures

Primary Outcomes (4)

• Video head impuls test (vHIT)

  The vHIT gives a gain value of the vestibulo-ocular reflex for each of the semicircular canals. The values of patients with STPHL will be compared with the values from the controls.

  Baseline

• Cervical vestibular evoked myogenic potential (cVEMP).

  cVEMP gives information whether the response can be recorded at all. The latency time to the response and the amplitude of the response will be measured. The values of patients with STPHL will be compared with the values from the controls.

  Baseline

• Ocular vestibular evoked myogenic potential (oVEMP).

  oVEMP gives information whether the response can be recorded at all. The latency time to the response and the amplitude of the response will be measured. The values of patients with STPHL will be compared with the values from the controls.

  Baseline

• Caloric irrigation

  This tests results in two measurements of slow phase velocity of the nystagmus in each ear. A total of four measurements when combining both ears. The values of patients with STPHL will be compared with the values from the controls.

  Baseline

Study Arms (2)

Patients with severe-to-profound hearing loss

Patients with severe-to-profound hearing loss will undergo investigation with caloric irrigation, video head impulse test and vestibular evoked myogenic potential. Patients will complete the Dizziness Handicap Inventory-questionnaire.

Diagnostic Test: Caloric irrigation; Diagnostic Test: vHIT; Diagnostic Test: VEMP

Controls

Controls will undergo investigation with caloric irrigation, video head impuls test and vestibular evoked myogenic potential. Controls will complete the Dizziness Handicap Inventory-questionnaire.

Diagnostic Test: Caloric irrigation; Diagnostic Test: vHIT; Diagnostic Test: VEMP

Interventions

Caloric irrigation DIAGNOSTIC_TEST

In a healthy ear irrigation with warm and cold water should give rise to an intense sensation of vertigo and involuntary eye movements called nystagmus. This nystagmus can be measured and thereby give an indication of the vestibular function in that ear.

Controls; Patients with severe-to-profound hearing loss

vHIT DIAGNOSTIC_TEST

This test measures the vestibular ocular reflex in all six semicircular canals (three in each ear). By performing a fast head thrust in the direction of the canal the eye response can be detected by a high-velocity video camera. A slower response indicates impaired function in that canal.

Controls; Patients with severe-to-profound hearing loss

VEMP DIAGNOSTIC_TEST

Utricular and saccular function can be measured by VEMP. Sound is presented in one ear at a time and the evoked myogenic potential in the sternocleidomastoid and the superior oblique muscles can be measured respectively. This gives a measurement of the function of the sacculus (cVEMP) and utriculus (oVEMP).

Controls; Patients with severe-to-profound hearing loss

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is made up by 50 patients with severe-to-profound hearing loss and 50 age-matched controls with age-adequate hearing levels.

You may qualify if:

• Hearing level of 70 decibel or worse in the better ear

You may not qualify if:

• Congenital deafness
• Presence of cochlear implant/implants
• Severe vision impairment
• Conductive hearing loss

Sponsors & Collaborators

• Värmland County Council, Sweden: lead

Study Sites (1)

Department of otorhinolaryngology

Karlstad, 66340, Sweden

Location

MeSH Terms

Conditions

Hearing Loss; Vestibular Diseases; Dizziness

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Labyrinth Diseases

Study Officials

• Per-Inge Carlsson, PhD

  University of Örebro, Faculty of medicine and health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: August 30, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

SE (1)