Hearing Loss, Sensorineural, SevereNCT05500521
Association Between Severe-to-profound Hearing Loss and the Balance Function of the Inner Ear
An observational study of Hearing Loss, Sensorineural, Severe and Hearing Loss, Sensorineural, Profound, run by Värmland County Council, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound, Vestibular Disorder
- What is being tested?
- Caloric irrigation, vHIT and VEMP
- How many people
- 98 participants
- Where
- 1 siteSweden
- Study dates
- 30 Aug 2022to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Hearing level of 70 decibel or worse in the better ear
Who cannot join
- Congenital deafness
- Presence of cochlear implant/implants
- Severe vision impairment
- Conductive hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Severe-to-profound Hearing Loss and the Vestibular Function of the Inner Ear
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.
Read the detailed description
Background: It is well known that uncorrected hearing loss can lead to increased feeling of exhaustion, social isolation and decreased quality of life. Sensorineural hearing loss originates from a damage to the cochlea in the inner ear or to the cochlear nerve and progresses with increasing age. Severe-to-profound hearing loss (STPHL) is defined as hearing levels 70 dB or worse on the better ear. The Swedish registry for adult patients with STPHL has showed that 30 % of the patients suffer from vertigo or dizziness often or always. The reasons for this are not established.
Apart from the cochlea the inner ear harbors the vestibular system consisting of the semicircular canals and the two otolithic organs, utriculus and sacculus. The vestibular system is the sensory system that helps us maintain balance. This study aims to investigate if patients with STPHL ie cochlear injury also have impaired vestibular function ie damage to the vestibular system.
The function of the vestibular system can be measured in three main ways. The semicircular canals can be assessed with caloric irrigation and video head impulse test (vHIT). The function of the sacculus and utriculus can be determined by the recording of vestibular evoked myogenic potential (VEMP). The sacculus is assessed by cervical VEMP (cVEMP) and the utriculus by ocular VEMP (oVEMP).
In patients with sensorineural STPHL the damage is most often located in the cochlea in the inner ear. The hypothesis in this study is that these patients also have a deteriorated function in the vestibular system. The aim of this study is to investigate whether the vestibular function between persons with STPHL differ from that of persons with age-adequate hearing levels.
Method: This study will be conducted in the county of Värmland in Sweden, a county with approximately 280,000 inhabitants. Auditbase is the hearing data software used in Värmland where all audiograms are stored. By conducting a database search The investigators have identified all patients in Värmland with severe-to-profound hearing loss.
Patients aged 50-85 years have been extracted from the initial pool of patients. Ethical approval has been gained from the Ethics Review Authority in Sweden. An invitation will be sent to these patients. Only patients with a strict sensorineural hearing loss will be included in the study. Patients with a cochlear implant will be excluded. After a signed informed consent has been retrieved from the patient a time for testing will be scheduled.
The patient will undergo testing with caloric irrigation, vHIT and VEMP. Prior to testing patient will undergo an otoscopy to verify an intact eardrum.
The tests are described in detail below.
Caloric irrigation: Bi thermal caloric irrigation is performed with 30 and 44 degree water. Eye movements are recorded with goggles that prevent visual fixation.Nystagmus is recorded for ten seconds prior to irrigation. Irrigation then follows for a total of 30 seconds. Nystagmus is then recorded during one minute followed by 10 seconds with fixation and finally 10 seconds without fixation. Slow phase velocity (SPV) is automatically calculated for each irrigation. Since both ears are measured with cold and warm water four SPV-values are recorded.
VHIT: This test is carried out in a well-lit room with the patient seated in a height-adjustable, rotatable chair. Fast head thrusts are performed in the direction of the semicircular canal. A high speed camera detects the head movement and the corresponding eye response is recorded. This gives a measurement of the vestibulo-ocular reflex in the tested canal. If the eye response matches the speed of the head movement the resulting gain value will be close to 1. With a slower eye response the gain value will decrease indicating impaired function in that canal.
VEMP: Utricular and saccular function can be measured by VEMP. Sound (500 Hz toneburst, 124 dB SPL) 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). The measurements that can be performed and analyzed are: response (yes/no), latency to the response and, amplitude of the response.
The results of the tests will be used to compare whether there are any detectable differences between patients with STPHL and the control group without STPHL.
- Conditions
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound, Vestibular Disorder
- Being tested
- Caloric irrigation, vHIT, VEMP
- Keywords
- hearing loss, vestibular function, video head impulse test, VEMP, caloric irrigation, dizziness
- Medical subject headings
- Hearing Loss, Vestibular Diseases, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric irrigationDiagnostic 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.
vHITDiagnostic 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.
VEMPDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Caloric irrigation; Diagnostic Test: vHIT; Diagnostic Test: VEMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start30 Aug 2022
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Sensorineural, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Per-Inge Carlsson, PhD, Principal investigator, University of Örebro, Faculty of medicine and health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500521
- Sponsor's protocol ID
- Hearing-vestibular
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Severe-to-profound Hearing Loss and the Vestibular Function of the Inner Ear
- ClinicalTrials.gov ID
- NCT05500521
- Acronym / sponsor ID
- Hearing-vestibular
- Conditions
- Hearing Loss, Sensorineural, Severe, Hearing Loss, Sensorineural, Profound, Vestibular Disorder
- Keywords
- hearing loss, vestibular function, video head impulse test, VEMP, caloric irrigation, dizziness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: It is well known that uncorrected hearing loss can lead to increased feeling of exhaustion, social isolation and decreased quality of life. Sensorineural hearing loss originates from a damage to the cochlea in the inner ear or to the cochlear nerve and progresses with increasing age. Severe-to-profound hearing loss (STPHL) is defined as hearing levels 70 dB or worse on the better ear. The Swedish registry for adult patients with STPHL has showed that 30 % of the patients suffer from vertigo or dizziness often or always. The reasons for this are not established.
Apart from the cochlea the inner ear harbors the vestibular system consisting of the semicircular canals and the two otolithic organs, utriculus and sacculus. The vestibular system is the sensory system that helps us maintain balance. This study aims to investigate if patients with STPHL ie cochlear injury also have impaired vestibular function ie damage to the vestibular system.
The function of the vestibular system can be measured in three main ways. The semicircular canals can be assessed with caloric irrigation and video head impulse test (vHIT). The function of the sacculus and utriculus can be determined by the recording of vestibular evoked myogenic potential (VEMP). The sacculus is assessed by cervical VEMP (cVEMP) and the utriculus by ocular VEMP (oVEMP).
In patients with sensorineural STPHL the damage is most often located in the cochlea in the inner ear. The hypothesis in this study is that these patients also have a deteriorated function in the vestibular system. The aim of this study is to investigate whether the vestibular function between persons with STPHL differ from that of persons with age-adequate hearing levels.
Method: This study will be conducted in the county of Värmland in Sweden, a county with approximately 280,000 inhabitants. Auditbase is the hearing data software used in Värmland where all audiograms are stored. By conducting a database search The investigators have identified all patients in Värmland with severe-to-profound hearing loss.
Patients aged 50-85 years have been extracted from the initial pool of patients. Ethical approval has been gained from the Ethics Review Authority in Sweden. An invitation will be sent to these patients. Only patients with a strict sensorineural hearing loss will be included in the study. Patients with a cochlear implant will be excluded. After a signed informed consent has been retrieved from the patient a time for testing will be scheduled.
The patient will undergo testing with caloric irrigation, vHIT and VEMP. Prior to testing patient will undergo an otoscopy to verify an intact eardrum.
The tests are described in detail below.
Caloric irrigation: Bi thermal caloric irrigation is performed with 30 and 44 degree water. Eye movements are recorded with goggles that prevent visual fixation.Nystagmus is recorded for ten seconds prior to irrigation. Irrigation then follows for a total of 30 seconds. Nystagmus is then recorded during one minute followed by 10 seconds with fixation and finally 10 seconds without fixation. Slow phase velocity (SPV) is automatically calculated for each irrigation. Since both ears are measured with cold and warm water four SPV-values are recorded.
VHIT: This test is carried out in a well-lit room with the patient seated in a height-adjustable, rotatable chair. Fast head thrusts are performed in the direction of the semicircular canal. A high speed camera detects the head movement and the corresponding eye response is recorded. This gives a measurement of the vestibulo-ocular reflex in the tested canal. If the eye response matches the speed of the head movement the resulting gain value will be close to 1. With a slower eye response the gain value will decrease indicating impaired function in that canal.
VEMP: Utricular and saccular function can be measured by VEMP. Sound (500 Hz toneburst, 124 dB SPL) 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). The measurements that can be performed and analyzed are: response (yes/no), latency to the response and, amplitude of the response.
The results of the tests will be used to compare whether there are any detectable differences between patients with STPHL and the control group without STPHL.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with severe-to-profound hearing loss | – | Diagnostic Test: Caloric irrigation, Diagnostic Test: vHIT, Diagnostic Test: VEMPPatients 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. |
| Controls | – | Diagnostic Test: Caloric irrigation, Diagnostic Test: vHIT, Diagnostic Test: VEMPControls will undergo investigation with caloric irrigation, video head impuls test and vestibular evoked myogenic potential. Controls will complete the Dizziness Handicap Inventory-questionnaire. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Hearing level of 70 decibel or worse in the better ear
Key exclusion criteria (4 listed)
- Congenital deafness
- Presence of cochlear implant/implants
- Severe vision impairment
- Conductive hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric irrigationIn 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. | Diagnostic test | Controls, Patients with severe-to-profound hearing loss |
| vHITThis 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. | Diagnostic test | Controls, Patients with severe-to-profound hearing loss |
| VEMPUtricular 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). | Diagnostic test | Controls, Patients with severe-to-profound hearing loss |
Primary outcome
Video head impuls test (vHIT)
Time frame: Baseline
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.
Cervical vestibular evoked myogenic potential (cVEMP).
Time frame: Baseline
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.
Ocular vestibular evoked myogenic potential (oVEMP).
Time frame: Baseline
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.
Caloric irrigation
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per-Inge Carlsson, PhD principal investigator
University of Örebro, Faculty of medicine and health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural, Severe and Hearing Loss, Sensorineural, Profound, run by Värmland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video head impuls test (vHIT) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.