Same-Day Cochlear Implant Activation (SDA-CI) (SDA-CI)
30 juni 2026 uppdaterad av: University of Aarhus
Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Louise Devantier, MD, PhD
- Telefonnummer: +45 78450000
- E-post: Louise.Devantier@aarhus.rm.dk
Studieorter
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Aarhus, Danmark, 8200
- Aarhus University Hospital
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Kontakt:
- Louise Devantier, MD, PhD
- Telefonnummer: +45 7845000
- E-post: Louise.Devantier@aarhus.rm.dk
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Same-Day Activation
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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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.
Andra namn:
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Aktiv komparator: Standard Day-14 Activation
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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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Electrode Impedance Development
Tidsram: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Longitudinal electrode impedance measurements obtained during routine cochlear implant programming sessions.
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Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Behavioural Stimulation Levels
Tidsram: Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Longitudinal changes in behavioural threshold (T-level) and comfort (C-level) stimulation settings during routine cochlear implant programming.
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Baseline (day 0), follow-up visits up to 2, 6 and 12 months postoperatively
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Time to Stable Cochlear Implant Map
Tidsram: At follow-up visits up to 2, 6 and 12 months postoperatively
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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.
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At follow-up visits up to 2, 6 and 12 months postoperatively
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Residual Hearing Preservation
Tidsram: Preoperative baseline and 6 months postoperatively
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Change in pure-tone audiometric thresholds following cochlear implantation.
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Preoperative baseline and 6 months postoperatively
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Tinnitus Severity
Tidsram: Through study completion, up to 12 months following cochlear implantation.
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Tinnitus severity assessed using the Tinnitus Handicap Inventory (THI)
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Through study completion, up to 12 months following cochlear implantation.
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Cochlear Implant-Related Quality of Life
Tidsram: Through study completion, up to 12 months following cochlear implantation.
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Quality of life assessed using the QOL-CI-35 questionnaire
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Through study completion, up to 12 months following cochlear implantation.
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Patient Experience of Initial Activation
Tidsram: Through study completion, up to 12 months following cochlear implantation.
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Patient-reported experience of first cochlear implant activation and activation-related discomfort assessed using visual analogue scales (VAS)
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Through study completion, up to 12 months following cochlear implantation.
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Device- or Wound-Related Complications
Tidsram: Through study completion, up to 12 months following cochlear implantation.
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Frequency of postoperative complications related to the cochlear implant device or surgical wound
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Through study completion, up to 12 months following cochlear implantation.
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Rehabilitation Trajectory
Tidsram: Through study completion, up to 12 months following cochlear implantation.
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Duration of rehabilitation and functional rehabilitation level obtained from municipal hearing and communication centres
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Through study completion, up to 12 months following cochlear implantation.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 augusti 2029
Avslutad studie (Beräknad)
1 december 2029
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
30 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AUH-CI-SDA-ADULT_2026
- 1-10-72-53-26 (Registeridentifierare: VEK Region Midt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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