Same-Day Cochlear Implant Activation (SDA-CI)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Indication for cochlear implantation according to national guidelines
Ability to provide written informed consent
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Same-Day Cochlear Implant Activation
Procedure/SurgeryActivation 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.
Standard Day-14 Cochlear Implant Activation
Procedure/SurgeryActivation 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Same-Day ActivationExperimental treatment 1 intervention
Group B: Standard Day-14 ActivationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Electrode Impedance Development
Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.
Time frame
Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperativelySecondary outcomes
1
Behavioural Stimulation Levels
Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming.
Time frame
Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively2
Time to Stable Cochlear Implant Map
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.
Time frame
At follow-up visits up to 2, 6 and 12 months postoperatively3
Residual Hearing Preservation
Change in pure-tone audiometric thresholds following cochlear implantation.
Time frame
Preoperative baseline and 6 months postoperatively4
Tinnitus Severity
Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)
Time frame
Through study completion, up to 12 months following cochlear implantation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: