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| ID | Type | Description | Link |
|---|---|---|---|
| 1-10-72-53-26 | Registry Identifier | VEK Region Midt |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same-Day Activation | Experimental | Participants randomized to this arm will have their cochlear implant activated on the day of surgery once clinically stable. Following activation, participants will continue with routine cochlear implant programming and rehabilitation according to standard clinical practice. |
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| Standard Day-14 Activation | Active Comparator | Participants randomized to this arm will have their cochlear implant activated approximately 14 days after surgery according to current standard clinical practice. Following activation, participants will continue with routine cochlear implant programming and rehabilitation according to standard clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Same-Day Cochlear Implant Activation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Electrode Impedance Development | Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions. | Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioural Stimulation Levels | Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming. | Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively |
| Time to Stable Cochlear Implant Map |
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Inclusion Criteria:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise Devantier, MD, PhD | Contact | +45 78450000 | Louise.Devantier@aarhus.rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Standard Day-14 Cochlear Implant Activation | Procedure | 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. |
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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. |
| At follow-up visits up to 2, 6 and 12 months postoperatively |
| Residual Hearing Preservation | Change in pure-tone audiometric thresholds following cochlear implantation. | Preoperative baseline and 6 months postoperatively |
| Tinnitus Severity | Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI) | Through study completion, up to 12 months following cochlear implantation. |
| Cochlear Implant-Related Quality of Life | Quality of life assessed using the QOL-CI-35 questionnaire | Through study completion, up to 12 months following cochlear implantation. |
| Patient Experience of Initial Activation | Patient-reported experience of first cochlear implant activation and activation-related discomfort assessed using visual analogue scales (VAS) | Through study completion, up to 12 months following cochlear implantation. |
| Device- or Wound-Related Complications | Frequency of postoperative complications related to the cochlear implant device or surgical wound | Through study completion, up to 12 months following cochlear implantation. |
| Rehabilitation Trajectory | Duration of rehabilitation and functional rehabilitation level obtained from municipal hearing and communication centres | Through study completion, up to 12 months following cochlear implantation. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |