Hearing Loss, SensorineuralNCT06021132
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
An observational study of Hearing Loss, Sensorineural and Hearing Loss, Bilateral, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
- What is being tested?
- cochlear implant
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2022to 28 Feb 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult CI-candidates are to be included from our tertiary referral centre at the Audiological Department at Aalborg University Hospital, Aalborg, Denmark.
Who may be able to join
- Adults (At or above 18 years of age and capable of giving an informed consent)
- Cochlear implant candidacy
- Profound bilateral post-lingual hearing loss
- Proficiency in Danish
- Expected ability to participate on both all pre- and postoperative examinations
- No previous CI experiences
Who cannot join
- Later abandonment of CI candidacy
- Blindness or visual handicap compromising eye movement evaluation
- Distinct neck mobility handicap hindering either vHIT- or cVEMP examination
- Patient reluctance, such as consistent no-show or cancellations of appointments
- CI-surgery before preoperative evaluation could be obtained
- Simultaneous bilateral cochlea implantation.
- Sequential CI within the follow-up period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
Aalborg, 9000
About this study
The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.
- Being tested
- cochlear implant
- Keywords
- Cochlear implant, Residual hearing, Hearing preservation
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantDevice
Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticipated increase in speech audiometric performances
The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months
Measured: +24 months from last inclusion. Expected to be complete in juli 2025.
Anticipated increase in patient reported outcome measures
The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months
Measured: +24 months from last inclusion. Expected to be complete in juli 2025.
Test-retest assessment of vestibular screening battery
Double examination using commercial video head impulse test system and cervical vestibular evoked myogenic potentials.
Measured: Conducted before cochlear implantation in all patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 May 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Bruun Kjærsgaard, Aalborg University Hospital
- Investigators
- Jonas B Kjlærsgaard, MD, Principal investigator, ENT department, Aalborg University HospitalMichael L Gaihede, PhD, MD, Study director, ENT department, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021132
- Sponsor's protocol ID
- RN-86132
- Status last verified
- Oct 2025
- First submitted
- 26 Aug 2023
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Full plan of analysis and raw data will be presented given there is still anonymity for the participants.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
- ClinicalTrials.gov ID
- NCT06021132
- Acronym / sponsor ID
- RN-86132
- Keywords
- Cochlear implant, Residual hearing, Hearing preservation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 1 Sep 2023 (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 study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult CI-candidates are to be included from our tertiary referral centre at the Audiological Department at Aalborg University Hospital, Aalborg, Denmark.
Key inclusion criteria (6 listed)
- Adults (At or above 18 years of age and capable of giving an informed consent)
- Cochlear implant candidacy
- Profound bilateral post-lingual hearing loss
- Proficiency in Danish
- Expected ability to participate on both all pre- and postoperative examinations
Key exclusion criteria (7 listed)
- Later abandonment of CI candidacy
- Blindness or visual handicap compromising eye movement evaluation
- Distinct neck mobility handicap hindering either vHIT- or cVEMP examination
- Patient reluctance, such as consistent no-show or cancellations of appointments
- CI-surgery before preoperative evaluation could be obtained
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 |
|---|---|---|
| cochlear implantInsertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech. | Device | – |
Primary outcome
Anticipated increase in speech audiometric performances
Time frame: +24 months from last inclusion. Expected to be complete in juli 2025.
The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months
Anticipated increase in patient reported outcome measures
Time frame: +24 months from last inclusion. Expected to be complete in juli 2025.
The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months
Test-retest assessment of vestibular screening battery
Time frame: Conducted before cochlear implantation in all patients.
Double examination using commercial video head impulse test system and cervical vestibular evoked myogenic potentials.
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 7 Oct 2025.
- Individual participant dataSharing planned: Undecided. Full plan of analysis and raw data will be presented given there is still anonymity for the participants.
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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.
Jonas B Kjlærsgaard, MD principal investigator
ENT department, Aalborg University Hospital
Michael L Gaihede, PhD, MD study director
ENT department, Aalborg University Hospital
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 and Hearing Loss, Bilateral, run by Aalborg University 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. 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?
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?
Anticipated increase in speech audiometric performances (time frame: +24 months from last inclusion. Expected to be complete in juli 2025.). The study lists 3 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 7 Oct 2025.