Cochlear Implantation, Hearing Loss
Conditions
Keywords
Cochlear Implant, Same-Day Activation, Early Activation, Electrode Impedance, Stable Cochlear Implant Map, Cochlear Implant Mapping
Brief summary
This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery. Adult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety. The purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.
Interventions
PROCEDURESame-Day Cochlear Implant Activation
Activation of the cochlear implant sound processor on the day of surgery after the participant is fully awake and clinically stable. Initial activation is performed according to routine clinical practice and followed by standard cochlear implant programming and rehabilitation.
PROCEDUREStandard Day-14 Cochlear Implant Activation
Activation of the cochlear implant sound processor approximately 14 days after surgery according to current standard clinical practice. Subsequent programming and rehabilitation follow routine cochlear implant care pathways.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Indication for cochlear implantation according to national guidelines * Ability to provide written informed consent
Exclusion criteria
- Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrode Impedance Development | Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively | Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience of Initial Activation | Through study completion, up to 12 months following cochlear implantation. | Patient-reported experience of first cochlear implant activation and activation-related discomfort assessed using visual analogue scales (VAS) |
| Device- or Wound-Related Complications | Through study completion, up to 12 months following cochlear implantation. | Frequency of postoperative complications related to the cochlear implant device or surgical wound |
| Rehabilitation Trajectory | Through study completion, up to 12 months following cochlear implantation. | Duration of rehabilitation and functional rehabilitation level obtained from municipal hearing and communication centres |
| Residual Hearing Preservation | Preoperative baseline and 6 months postoperatively | Change in pure-tone audiometric thresholds following cochlear implantation. |
| Tinnitus Severity | Through study completion, up to 12 months following cochlear implantation. | Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI) |
| Behavioural Stimulation Levels | Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively | Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming. |
| Cochlear Implant-Related Quality of Life | Through study completion, up to 12 months following cochlear implantation. | Quality of life assessed using the QOL-CI-35 questionnaire |
| Time to Stable Cochlear Implant Map | At follow-up visits up to 2, 6 and 12 months postoperatively | Time from initial cochlear implant activation to achievement of a stable clinical cochlear implant map, defined as no clinically relevant need for further adjustment of stimulation levels at routine programming visits. |
Countries
Denmark
Contacts
CONTACTLouise Devantier, MD, PhD
Outcome results
None listed