Language Proficiency and Quality of Life After Receiving Cochlear Implantation as a Child

NCT ID: NCT01863875

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 530 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2023-12-31

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.

Detailed Description

Test protocol includes:

Hearing and Language assessment:

Single syllable word perception, Hearing in noise test (HINT), Mullen Scale of Early Learning, British Picture Vocabulary Scale, Peabody Picture Vocabulary Test - Fourth Edition, Clinical Evaluation of Language Fundamentals (CELF) - Fourth Edition 4 , Raven progressive matrices, Motor Coordination + Visual Perception (VMI), Wechsler Preschool and Primary Scale of Intelligence (WPPSI), Wechsler Intelligence Scale for Children (WISC) and Wechsler Adult Intelligence Scale (WAIS).

Quality of Life assessment:

Satisfaction of Life Scale for Children Pediatric Quality of Life Inventory TM (PedsQL TM) Questionnaire for quality of life assessments (KINDL)

Conditions

Hearing Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Normal hearing people

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Norwegian Directorate of Health

OTHER_GOV

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ona Bø Wie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terje A Osnes, Professor

Role: STUDY_CHAIR

Oslo University Hospital

Locations

Oslo University Hospital, Department of Otolaryngology

Olso, Olso, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Christiane Haukedal, Phd cand.

Role: CONTACT

christiane.haukedal@isp.uio.no

+4740885649

Ona B Wie, Professor

Role: CONTACT

owie@ous-hf.no

+4790920274

Facility Contacts

Ona B Wie, Professor

Role: primary

owie@ous-hf.no

+4790920274

Terje A Osnes, Professor

Role: backup

t.a.osnes@medisin.uio.no

+47 20371784

Other Identifiers

2012/2154

Identifier Type: -

Identifier Source: org_study_id