Sensorineural Hearing LossEPIHEARNCT06507007
Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome
An observational study of Sensorineural Hearing Loss and Turner Syndrome, run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss, Turner Syndrome, Inner Ear Disease
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Three different populations will be included as it is expected that 50% of the TS population suffer from SNHL: * 50 individuals with TS and SNHL * 50 individuals with TS without SNHL * 50 healthy controls without TS and SNHL The participants are recruited from an existing cohort.
Who may be able to join
- age between 18 and 60 years old
Who cannot join
- Contraindications for the MRI or CBCT
- Serious medical disorders
- Neurological or psychiatric disorders of any kind
- Use of medication that is known to influence inner ear function
- Medical history with dizziness or hearing problems (controls only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
ENT department of Gødstrup Hospital
Herning, 7400
Louise Hill-Madsen, MD, PhD student, (45+) 78439744, lohill@rm.dk
Therese Ovesen, Professor, theroves@rm.dk
About this study
The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS).
The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile.
Read more
The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases?
Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL).
Participants will undergo the following tests:
- Ear examinations
- Hearing tests
- Balance tests
- Blood tests
- MRI scans
- CBCT (cone-beam computed tomography) scans
- Keywords
- Epigenetics, Sensorineural hearing loss, Turner Syndrome, Inner Ear Dysfunction
- Medical subject headings
- Hearing Loss, Sensorineural, Turner Syndrome, Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Individuals with TS and SNHL | |
| Group 2 | Individuals with TS without SNHL | |
| Group 3 | Healthy age matched controls without TS and without SNHL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic profile
DNA methylation analyses are conducted on the purified DNA. RNA expression analyses and ChIP-seq are performed on the purified RNA. Based on this, the epigenetic profile will be mapped to identify consistent differences associated with SNHL.
Measured: 2024-2026
Secondary outcomes (3)
Hearing ability
Hearing level thresholds and bone conduction is assesed by pure tone audiometry.
Measured: 2024-2026
Vestibular status
The vestibular function is assessed using the video head impulse test (vHIT), vestibular evoked myogenic potentials, and posturography.
Measured: 2024-2026
Structural malformations
Anatomy and inner ear malformations are examined using Conebeam CT and MRI.
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Feb 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Responsible party
- Principal investigator, Louise Hill-Madsen, Gødstrup Hospital
- Investigators
- Therese Ovesen, Prof, Principal investigator, University Clinic of Flavour, Balance and Sleep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507007
- Sponsor's protocol ID
- LHM-TS-2024
- Acronym
- EPIHEAR
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2024
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome
- ClinicalTrials.gov ID
- NCT06507007
- Acronym / sponsor ID
- EPIHEAR / LHM-TS-2024
- Keywords
- Epigenetics, Sensorineural hearing loss, Turner Syndrome, Inner Ear Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 18 Jul 2024 (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.
The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS).
The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile.
The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases?
Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL).
Participants will undergo the following tests:
- Ear examinations
- Hearing tests
- Balance tests
- Blood tests
- MRI scans
- CBCT (cone-beam computed tomography) scans
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Individuals with TS and SNHL |
| Group 2 | – | –Individuals with TS without SNHL |
| Group 3 | – | –Healthy age matched controls without TS and without SNHL |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Three different populations will be included as it is expected that 50% of the TS population suffer from SNHL: * 50 individuals with TS and SNHL * 50 individuals with TS without SNHL * 50 healthy controls without TS and SNHL The participants are recruited from an existing cohort.
Key inclusion criteria (1 listed)
- age between 18 and 60 years old
Key exclusion criteria (5 listed)
- Contraindications for the MRI or CBCT
- Serious medical disorders
- Neurological or psychiatric disorders of any kind
- Use of medication that is known to influence inner ear function
- Medical history with dizziness or hearing problems (controls only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epigenetic profile
Time frame: 2024-2026
DNA methylation analyses are conducted on the purified DNA. RNA expression analyses and ChIP-seq are performed on the purified RNA. Based on this, the epigenetic profile will be mapped to identify consistent differences associated with SNHL.
3 secondary outcomes
Hearing ability
Time frame: 2024-2026
Vestibular status
Time frame: 2024-2026
Structural malformations
Time frame: 2024-2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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.
Therese Ovesen, Prof principal investigator
University Clinic of Flavour, Balance and Sleep
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 Sensorineural Hearing Loss and Turner Syndrome, run by Gødstrup Hospital at 1 site in Denmark.
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 5 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: looking for participants now, as of the sponsor's last update on 11 Sep 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Hill-Madsen, MD (20282635 ext. 0045, lohill@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic profile (time frame: 2024-2026). 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 11 Sep 2026.