Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients. (LORIS)
5. august 2026 opdateret af: MED-EL Elektromedizinische Geräte GesmbH
Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
However, there is only few evidence from large long-term observational studies available to gain knowledge on clinical effectiveness of cochlear implants. With continued pressure on healthcare system budgets, there is an increasing demand for evidence-based research that demonstrates an intervention is effective in the real-world environment across large and diverse populations. Currently, there is a paucity of data concerning the long-term outcomes of subjects implanted with a SONATA 2 cochlear implant from representative samples of the population. This retrospective study aims at analyzing SONATA 2 cochlear implant data from clinical routine.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Data from SONATA 2 CI recipients will be transferred to predefined fields in an electronic data capture system (CASTOR EDC) by the investigators.
The data transfer starts after the approval of the Ethics Committees (EC).
Data will be included for all subjects who meet the inclusion/exclusion criteria
Undersøgelsestype
Observationel
Tilmelding (Anslået)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jasmine Rinnofner
- Telefonnummer: +43577881694
- E-mail: jasmine.rinnofner@medel.com
Studiesteder
-
-
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz
-
Kontakt:
- Luis Lassaletta Atienza, Dr.
- Telefonnummer: +34 91 207 1651
- E-mail: llassaletta@salud.madrid.org
-
Valencia, Spanien, 46026
- Hospital Universitario y Politécnico La Fe
-
Kontakt:
- Laura Cavallé Garrido, Dr.
- Telefonnummer: +43577881694
- E-mail: cavallelaura@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
In this retrospective observational study, the inclusion and exclusion criteria encompass all individuals with a SONATA 2 cochlear implant at the study centers.
By including all individuals with a SONATA 2 cochlear implant from the study centers, the investigation population is representative of the target population.
The investigation population is representative of "real-world" users of SONATA 2 cochlear implant.
Beskrivelse
Inclusion Criteria:
- At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor
Exclusion Criteria:
- Lack of compliance with any inclusion criteria
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Bisyllables recognition score in quiet
Tidsramme: pre-operative to 5 years post-operative
|
pre-operative to 5 years post-operative
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bisyllables recognition score in noise
Tidsramme: pre-operative to 5 years post-operative
|
pre-operative to 5 years post-operative
|
|
|
Wearing time
Tidsramme: up to 5 years post-operative
|
Wearing time in hours of audio processor used together with SONATA 2 cochlear implant
|
up to 5 years post-operative
|
|
Complications related to the device or procedure
Tidsramme: up to 5 years post-operative
|
up to 5 years post-operative
|
|
|
Device parameter
Tidsramme: up to 5 years post-operative
|
Descriptive summary of which electrode type was used together with a SONATA 2 cochlear implant
|
up to 5 years post-operative
|
|
Device parameter
Tidsramme: up to 5 years post-operative
|
Descriptive summary of which audio processor type was used together with a SONATA 2 cochlear implant
|
up to 5 years post-operative
|
|
Demographic information
Tidsramme: pre-operative
|
descriptive summary of demographics
|
pre-operative
|
|
Questionnaire scores
Tidsramme: pre-operative to 5 years post-operative
|
Hearing Implant Sound Quality Index (HISQUI19).
Total score range from 19 to 133 points.
The higher the score the better the outcome.
|
pre-operative to 5 years post-operative
|
|
Questionnaire scores
Tidsramme: pre-operative to 5 years post-operative
|
Speech, Spatial, and Qualities of Hearing Scale (SSQ).
Total score range from 0 to 10 points.
The higher the score the better the outcome.
|
pre-operative to 5 years post-operative
|
|
Questionnaire scores
Tidsramme: pre-operative to 5 years post-operative
|
LittlEars Auditory Questionnaire (LEAQ).
Total score range from 0 to 35 points.
The higher the score the better the outcome.
|
pre-operative to 5 years post-operative
|
|
Questionnaire scores
Tidsramme: pre-operative to 5 years post-operative
|
Glasgow Benefit Inventory (GBI).
Total score range from -100 to +100points.
The higher the score the better the outcome.
|
pre-operative to 5 years post-operative
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. maj 2027
Datoer for studieregistrering
Først indsendt
24. juni 2026
Først indsendt, der opfyldte QC-kriterier
6. juli 2026
Først opslået (Faktiske)
13. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MED-EL_CRD_2025_01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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