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Not yet recruiting NCT07681830

Same-Day Cochlear Implant Activation (SDA-CI)

No phase Interventional Hearing Loss Cochlear Implantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Same-Day Cochlear Implant Activation, Standard Day-14 Cochlear Implant Activation.
Who it may be relevant to
Registry conditions: Hearing Loss, Cochlear Implantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients

Overview

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

  • Procedure Same-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.
  • Procedure Standard 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.

Primary outcome measures

  • Electrode Impedance Development [Time frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively]
Secondary outcome measures (8)
  • Behavioural Stimulation Levels [Time frame: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively]
  • Time to Stable Cochlear Implant Map [Time frame: At follow-up visits up to 2, 6 and 12 months postoperatively]
  • Residual Hearing Preservation [Time frame: Preoperative baseline and 6 months postoperatively]
  • Tinnitus Severity [Time frame: Through study completion, up to 12 months following cochlear implantation.]
  • Cochlear Implant-Related Quality of Life [Time frame: Through study completion, up to 12 months following cochlear implantation.]
  • Patient Experience of Initial Activation [Time frame: Through study completion, up to 12 months following cochlear implantation.]
  • Device- or Wound-Related Complications [Time frame: Through study completion, up to 12 months following cochlear implantation.]
  • Rehabilitation Trajectory [Time frame: Through study completion, up to 12 months following cochlear implantation.]

Eligibility criteria

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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Aarhus University Hospital — Aarhus

Identifiers

NCT: NCT07681830 · AUH-CI-SDA-ADULT_2026 · 1-10-72-53-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗