Bilateral cochlear implantation in children has potentially an advantage over unilateral cochlear implantation in terms of communication development (both preverbal communication and language development) and sound localization. This study will…
ID
Bron
Verkorte titel
Aandoening
Deafness
Hearing loss
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Performance on the non-looking vocal turns (NLVT) component of the Tait video analysis in the individual patient¡¯s best aided condition.
Achtergrond van het onderzoek
This study will investigate the benefit of bilateral cochlear implantation over unilateral cochlear implantation in children who are implanted with two cochlear implants either simultaneously or sequentially. The objective is to evaluate the degree of bilateral benefit gained from having a second implant. 45 Children with severe to profound sensorineural hearing loss will be included in this Randomised Controlled Trial. Half of the group shall receive one implant at the beginning of the study and a second implant after a period of two years. The other half shall receive two cochlear implants simultaneously during one operation. Objective and subjective parameters will be measured during evaluation sessions pre-operatively, 6, 12, 24, 36 and 48 months after the first cochlear implantation.
Doel van het onderzoek
Bilateral cochlear implantation in children has potentially an advantage over unilateral cochlear implantation in terms of communication development (both preverbal communication and language development) and sound localization. This study will compare the effects of simultaneous and sequential bilateral cochlear implantation. This not only allows to compare the effects of simultaneous and sequential bilateral cochlear implantation , but also of unilateral and bilateral cochlear implantation.
Onderzoeksopzet
1. Preoperatively;
2. 6 months post (first) implantation;
3. 12 months post (first) implantation;
4. 24 months post (first) implantation;
5. 36 months post (first) implantation;
6. 48 months post (first) implantation.
Onderzoeksproduct en/of interventie
Simultaneous or sequential bilateral cochlear implantation.
Publiek
Heidelberglaan 100
M.J.W. Lammers
Utrecht 3508 GA
The Netherlands
m.j.w.lammers-2@umcutrecht.nl
Wetenschappelijk
Heidelberglaan 100
M.J.W. Lammers
Utrecht 3508 GA
The Netherlands
m.j.w.lammers-2@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age ¡Ü 2 years;
2. Current clinically used cochlear implant criteria of the multidisciplinary cochlear implant team of the UMC Utrecht;
3. Willingness and ability of parents or guardians to participate in all scheduled procedures outlined in the protocol;
4. General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery;
5. Patients covered by the Dutch health insurance.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Abnormal cochlear anatomy in one or both ears;
2. Chronic ear infection in one or both ears;
3. Previous implant experience;
4. Disability which could interfere with the completion of the tests;
5. Deafness caused by meningitis, otosclerosis or Cogans syndrome;
6. Severely visually impaired.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3084 |
| NTR-old | NTR3232 |
| CCMO | NL34845.041.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36764 |