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

Assessment of Listening, Speech, and Language Proficiency, and of Experienced Quality of Life in People Who Have Received Cochlear Implants as Children.

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss

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)

• Study Type: Observational
• Enrollment (Anticipated): 530

Contacts and Locations

• Study Contact: Name: Christiane Haukedal, Phd cand.; Phone Number: +4740885649; Email: christiane.haukedal@isp.uio.no
• Study Contact Backup: Name: Ona B Wie, Professor; Phone Number: +4790920274; Email: owie@ous-hf.no

Study Locations

• Norway
  • Olso, Norway, 0424
    • Recruiting
    • Oslo University Hospital, Department of Otolaryngology
    • Contact: Ona B Wie, Professor; Phone Number: +4790920274; Email: owie@ous-hf.no
    • Contact: Terje A Osnes, Professor; Phone Number: +47 20371784; Email: t.a.osnes@medisin.uio.no
    • Principal Investigator: Ona B Wie, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing and listen skills	Single syllable word perception, HINT hearing in noise test	2013-2023 (up to 20 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech and language skills	Mullen Scale of Early Learning, British Picture Vocabulary Scale Clinical Evaluation of Language Fundamentals - Fourth Edition 4 CELF	2013-2032 (up to 20 years)

Other Outcome Measures

Outcome Measure	Time Frame
Quality of life	2013-2023 (up to 20 years)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Norwegian Directorate of Health
• Investigators: Study Chair: Terje A Osnes, Professor, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (ESTIMATE): May 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Quality of life; Cochlear Implant; Hearing loss; Language Development
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 2012/2154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO