Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Key facts
- Who runs it
- Aalborg University Hospital
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 39 people enrolled
- Started
- 1 May 2022
- Expected to end
- 28 Feb 2028
- Type of study
- Observational
- Treatments tested
- cochlear implant
- Record updated
- 7 October 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- CI-surgery before preoperative evaluation could be obtained
- 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
- Simultaneous bilateral cochlea implantation
- Sequential CI within the follow-up period
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Treatments tested
- cochlear implant
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 7 October 2025