DeafnessFinBiCINCT00960102
Children's Bilateral Cochlear Implantation in Finland
A study testing cochlear implant and hearing aid in people with Deafness and Hearing Loss, run by Kuopio University Hospital at 5 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Deafness, Hearing Loss
- What is being tested?
- cochlear implant and hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesFinland
- Study dates
- Aug 2009to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Department of Otorhinolaryngology, Helsinki University Hospital
Helsinki
Department of Otorhinolaryngology, Kuopio University Hospital
Kuopio, 70211
Department of Otorhinolaryngology, Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Department of Otorhinolaryngology, Turku University Hospital
Turku
About this study
Official title: Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
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.
- Conditions
- Deafness, Hearing Loss
- Being tested
- cochlear implant, hearing aid
- Keywords
- cochlear implantation, hearing aid
- Medical subject headings
- Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantDevice
Multichannel Nucleus cochlear implant
hearing aidDevice
Phonak hearing aid
| Study group | Role | What they receive |
|---|---|---|
| bilateral cochlear implant | Active comparator | Not described Receives: Device: cochlear implant |
| cochlear implant and hearing aid | Active comparator | Not described Receives: Device: cochlear implant; Device: hearing aid |
| bilateral hearing aid | Active comparator | Not described Receives: Device: hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
Measured: Various time points up to 5 years hearing age
Secondary outcomes (5)
To compare post-operative speech perception ability, language acquisition, and speech production
Measured: Various time points up to 5 years hearing age
To compare speech recognition performance
Measured: Various time points up to 5 years hearing age
Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment
Measured: Various time points up to 5 years hearing age
To evaluate operative and post-operative complications, side-effects and device failures
Measured: Various time points up to 5 years hearing age
To evaluate the differences in balance function
Measured: at 3 and 5 year age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startAug 2009
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, Hospital District of Helsinki and Uusimaa, University of Helsinki, Oulu University Hospital, University of Oulu, Turku University Hospital, Tampere University Hospital
- Responsible party
- Principal investigator, Heikki Lopponen, Kuopio University Hospital
- Investigators
- Heikki J Löppönen, M.D.,Prof., Study director, Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, FinlandTaina T Välimaa, Ph.D., Principal investigator, Faculty of Humanities, Logopedics, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960102
- Sponsor's protocol ID
- KUH5551819
- Acronym
- FinBiCI
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2009
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Valimaa TT, Kunnari S, Aarnisalo AA, Dietz A, Hyvarinen A, Laitakari J, Mykkanen S, Rimmanen S, Salonen J, Sivonen V, Tennila T, Tsupari T, Vikman S, Virokannas N, Laukkanen-Nevala P, Tolonen AK, Tuohimaa K, Lopponen H. Spoken Language Skills in Children With Bilateral Hearing Aids or Bilateral Cochlear Implants at the Age of Three Years. Ear Hear. 2022 Jan/Feb;43(1):220-233. doi: 10.1097/AUD.0000000000001092.
PubMed 34260435
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT00960102
- Acronym / sponsor ID
- FinBiCI / KUH5551819
- Conditions
- Deafness, Hearing Loss
- Keywords
- cochlear implantation, hearing aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland, Hospital District of Helsinki and Uusimaa, University of Helsinki, Oulu University Hospital, University of Oulu, Turku University Hospital, Tampere University Hospital
- Study start
- Aug 2009 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bilateral cochlear implant | Active comparator | Device: cochlear implant |
| cochlear implant and hearing aid | Active comparator | Device: cochlear implant, Device: hearing aid |
| bilateral hearing aid | Active comparator | Device: hearing aid |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cochlear implantMultichannel Nucleus cochlear implant | Device | bilateral cochlear implant, cochlear implant and hearing aid |
| hearing aidPhonak hearing aid | Device | bilateral hearing aid, cochlear implant and hearing aid |
Primary outcome
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
Time frame: Various time points up to 5 years hearing age
5 secondary outcomes
To compare post-operative speech perception ability, language acquisition, and speech production
Time frame: Various time points up to 5 years hearing age
To compare speech recognition performance
Time frame: Various time points up to 5 years hearing age
Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment
Time frame: Various time points up to 5 years hearing age
To evaluate operative and post-operative complications, side-effects and device failures
Time frame: Various time points up to 5 years hearing age
To evaluate the differences in balance function
Time frame: at 3 and 5 year age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 34260435Valimaa TT, Kunnari S, Aarnisalo AA, Dietz A, Hyvarinen A, Laitakari J, Mykkanen S, Rimmanen S, Salonen J, Sivonen V, Tennila T, Tsupari T, Vikman S, Virokannas N, Laukkanen-Nevala P, Tolonen AK, Tuohimaa K, Lopponen H. Spoken Language Skills in Children With Bilateral Hearing Aids or Bilateral Cochlear Implants at the Age of Three Years. Ear Hear. 2022 Jan/Feb;43(1):220-233. doi: 10.1097/AUD.0000000000001092.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki J Löppönen, M.D.,Prof. study director
Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland
Taina T Välimaa, Ph.D. principal investigator
Faculty of Humanities, Logopedics, University of Oulu, Finland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cochlear implant and hearing aid in people with Deafness and Hearing Loss, run by Kuopio University Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids (time frame: Various time points up to 5 years hearing age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.