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

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ClinicalTrials.gov Identifier: NCT01863875
Recruitment Status : Recruiting
First Posted : May 29, 2013
Last Update Posted : April 7, 2016
Sponsor:
Collaborators:
University of Oslo
Norwegian Directorate of Health
Information provided by (Responsible Party):
Ona Bø Wie, Oslo University Hospital

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.

Condition or disease
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)


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Study Type : Observational
Estimated Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Listening, Speech, and Language Proficiency, and of Experienced Quality of Life in People Who Have Received Cochlear Implants as Children.
Study Start Date : January 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Hearing and listen skills [ Time Frame: 2013-2023 (up to 20 years) ]
    Single syllable word perception, HINT hearing in noise test


Secondary Outcome Measures :
  1. Speech and language skills [ Time Frame: 2013-2032 (up to 20 years) ]
    Mullen Scale of Early Learning, British Picture Vocabulary Scale Clinical Evaluation of Language Fundamentals - Fourth Edition 4 CELF


Other Outcome Measures:
  1. Quality of life [ Time Frame: 2013-2023 (up to 20 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All people in Norway that have received Cochlear Implants as a child.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863875


Contacts
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Contact: Christiane Haukedal, Phd cand. +4740885649 christiane.haukedal@isp.uio.no
Contact: Ona B Wie, Professor +4790920274 owie@ous-hf.no

Locations
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Norway
Oslo University Hospital, Department of Otolaryngology Recruiting
Olso, Norway, 0424
Contact: Ona B Wie, Professor    +4790920274    owie@ous-hf.no   
Contact: Terje A Osnes, Professor    +47 20371784    t.a.osnes@medisin.uio.no   
Principal Investigator: Ona B Wie, Professor         
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Norwegian Directorate of Health
Investigators
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Study Chair: Terje A Osnes, Professor Oslo University Hospital

Additional Information:

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Responsible Party: Ona Bø Wie, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01863875     History of Changes
Other Study ID Numbers: 2012/2154
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ona Bø Wie, Oslo University Hospital:
Cochlear Implant
Hearing loss
Language Development
Quality of life

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms