NCT06021132

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
May 2022Feb 2028

Study Start

First participant enrolled

May 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

5.1 years

First QC Date

August 26, 2023

Last Update Submit

October 1, 2025

Conditions

Hearing Loss, SensorineuralHearing Loss, Bilateral

Keywords

Cochlear implantResidual hearingHearing preservation

Outcome Measures

Primary Outcomes (3)

  • 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

    +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

    +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.

    Conducted before cochlear implantation in all patients.

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss, Bilateral

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Officials

  • Jonas B Kjlærsgaard, MD

    ENT department, Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

  • Michael L Gaihede, PhD, MD

    ENT department, Aalborg University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 1, 2023

Study Start

May 1, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

October 7, 2025

Record last verified: 2025-10

Locations

DK(1)