Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00960102
Other study ID # KUH5551819
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2009
Est. completion date December 31, 2022

Study information

Verified date August 2022
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation and bilateral hearing aid rehabilitation in Finnish children.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Months
Eligibility Inclusion Criteria: - Congenital severe or profound bilateral hearing impairment - No functional benefit from conventional hearing aids (minimum 3 months trial) - Radiologically (CT,MRI) patent inner ears and normal central auditory pathways - Family is motivated for rehabilitation programme and gives a written consent - Finnish or Swedish as the primary language in the home Exclusion Criteria: - A child has an additional anomaly or disability that may affect to his/her functional or neurological development - Inner ear anomaly - Mother's pregnancy duration less than 32 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Device:
cochlear implant
Multichannel Nucleus cochlear implant
hearing aid
Phonak hearing aid

Locations

Country Name City State
Finland Department of Otorhinolaryngology, Helsinki University Hospital Helsinki
Finland Department of Otorhinolaryngology, Kuopio University Hospital Kuopio
Finland Department of Otorhinolaryngology, Oulu University Hospital Oulu
Finland Tampere University Hospital Tampere
Finland Department of Otorhinolaryngology, Turku University Hospital Turku

Sponsors (8)

Lead Sponsor Collaborator
Kuopio University Hospital Hospital District of Helsinki and Uusimaa, Oulu University Hospital, Tampere University Hospital, Turku University Hospital, University of Eastern Finland, University of Helsinki, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids Various time points up to 5 years hearing age
Secondary To compare post-operative speech perception ability, language acquisition, and speech production Various time points up to 5 years hearing age
Secondary To compare speech recognition performance Various time points up to 5 years hearing age
Secondary Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment Various time points up to 5 years hearing age
Secondary To evaluate operative and post-operative complications, side-effects and device failures Various time points up to 5 years hearing age
Secondary To evaluate the differences in balance function at 3 and 5 year age
See also
  Status Clinical Trial Phase
Recruiting NCT04696835 - fNIRS in Pediatric Hearing Aids N/A
Completed NCT03662256 - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine N/A
Completed NCT04602780 - Evaluating the Revised WORQ in CI Users
Completed NCT03723161 - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03428841 - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients N/A
Completed NCT04559282 - Home Test of New Sound Processor N/A
Enrolling by invitation NCT03345654 - Individually-guided Hearing Aid Fitting
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Completed NCT05165121 - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids N/A
Recruiting NCT05533840 - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Terminated NCT02294812 - Effects of Cognitive Training on Speech Perception N/A
Completed NCT04622059 - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis N/A
Recruiting NCT02558478 - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing N/A
Withdrawn NCT02740322 - Validating the Hum Test N/A
Completed NCT01963104 - Community-Based Kiosks for Hearing Screening and Education N/A
Completed NCT01892007 - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users N/A
Completed NCT01857661 - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial N/A
Withdrawn NCT01223638 - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism N/A