NCT01863875

Brief Summary

Treatment with cochlear implantation is now offered to proximately 95 % of children with deafness in Norway. More than 500 children have been operated at Oslo University Hospital. The study is a cross-sectional study aimed to investigate speech perception, language skills, quality of life in all childhood cochlear implant (CI) recipients in Norway from 1988-2012. Factors such as child characteristics, characteristics with the family, the cochlear implant, the rehabilitation situation, choice of communication mode, school and work situation are surveyed to see if these factors can be associated with variations in outcome. The study will include pre and post lingual deaf children and children with multiple disabilities. Participants are recruited and examined in conjunction with their annual CI control at the hospital. It will be conducted a series of tests determining listening, speech and language development, non-verbal intelligence. Questionnaires are used to collect background information and quality of life experience. The questionnaires include self-report forms for different age groups, and a parent report form. The patient will be tested for the most common genetic causes of deafness. Additional data will be collected from patient records and from local health register at Oslo University Hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

10.9 years

First QC Date

May 23, 2013

Last Update Submit

April 6, 2016

Conditions

Keywords

Cochlear ImplantHearing lossLanguage DevelopmentQuality of life

Outcome Measures

Primary Outcomes (1)

  • Hearing and listen skills

    Single syllable word perception, HINT hearing in noise test

    2013-2023 (up to 20 years)

Secondary Outcomes (1)

  • Speech and language skills

    2013-2032 (up to 20 years)

Other Outcomes (1)

  • Quality of life

    2013-2023 (up to 20 years)

Study Arms (2)

Childhood cochlear implant recipients

The sample includes all childhood cochlear implant (CI) recipients at Oslo University Hospital in Norway from 1988-2012. The participant must have at least one year of CI-user time. Possible sample size is 530 children. The age span is from 1 to 50 years.

Normal hearing people

Reference group: A group of normal hearing people matching the target group on gender and age.

Eligibility Criteria

Age18 Months - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All people in Norway that have received Cochlear Implants as a child.

You may qualify if:

  • All people in Norway that have received Cochlear implants as a child and that have one or more than one year with CI experience.

You may not qualify if:

  • Cochlear implant users with less than one year with CI experience and people implanted after 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Department of Otolaryngology

Olso, Olso, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Terje A Osnes, Professor

    Oslo University Hospital

    STUDY CHAIR

Central Study Contacts

Christiane Haukedal, Phd cand.

CONTACT

Ona B Wie, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 29, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations