Same-Day Cochlear Implant Activation (SDA-CI) (SDA-CI)
30. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Louise Devantier, MD, PhD
- Telefonnummer: +45 78450000
- E-post: Louise.Devantier@aarhus.rm.dk
Studiesteder
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Aarhus, Danmark, 8200
- Aarhus University Hospital
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Ta kontakt med:
- Louise Devantier, MD, PhD
- Telefonnummer: +45 7845000
- E-post: Louise.Devantier@aarhus.rm.dk
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Electrode Impedance Development
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Behavioural Stimulation Levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. august 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
30. juni 2026
Først lagt ut (Faktiske)
2. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AUH-CI-SDA-ADULT_2026
- 1-10-72-53-26 (Registeridentifikator: VEK Region Midt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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