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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01863875
• Other study ID #: 2012/2154
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2013
• Last updated: April 6, 2016
• Start date: January 2013
• Est. completion date: December 2023

Study information

• Verified date: April 2016
• Source: Oslo University Hospital
• Contact: Christiane Haukedal, Phd cand.
• Phone: +4740885649
• Email: christiane.haukedal[@]isp.uio.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Department of Otolaryngology	Olso

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Directorate of Health, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life		2013-2023 (up to 20 years)	No
Primary	Hearing and listen skills	Single syllable word perception, HINT hearing in noise test	2013-2023 (up to 20 years)	No
Secondary	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)	No