Clinical trial NCT06021132: Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Official title: Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Keywords: Cochlear implant
Residual hearing
Hearing preservation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult CI-candidates are to be included from our tertiary referral centre at the Audiological Department at Aalborg University Hospital, Aalborg, Denmark.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Anticipated increase in speech audiometric performances
timeFrame: +24 months from last inclusion. Expected to be complete in juli 2025.
measure: Anticipated increase in patient reported outcome measures
timeFrame: +24 months from last inclusion. Expected to be complete in juli 2025.
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
Study officials:
affiliation: ENT department, Aalborg University Hospital
name: Jonas B Kjlærsgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ENT department, Aalborg University Hospital
name: Michael L Gaihede, PhD, MD
role: STUDY_DIRECTOR
References: