CINGLE-studie: Cochleaire Implantatie bij siNGLE-sided deafness
Completed
- Conditions
- <p>single-sided deafness, unilateral hearing loss, single-sided hearing loss, unilateral deafness, eenzijdige doofheid, unilaterale doofheid, eenzijdig gehoorverlies, unilateraal gehoorverlies</p>
- Registration Number
- NL-OMON26952
- Lead Sponsor
- Department of Otorhinolaryngology and Head & Neck Surgery University Medical Center Utrecht, Utrecht, The Netherlands
- Brief Summary
Study protocol: https://bmcearnosethroatdisord.biomedcentral.com/articles/10.1186/s12901-015-0016-y
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Age 18 or older.
- Acute onset of postlingual SSD, defined as onset unilateral hearing loss between ≥3 months and ≤10 years before time of inclusion.
Exclusion Criteria
- previous experience with implanted BCD or CI
- retrocochlear pathology - abnormal cochlear anatomy in one or both ears (i.e. ossification)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Performance on the modified Plomp hearing test.</p>
- Secondary Outcome Measures
Name Time Method <p>- Performance on the Standard Dutch phoneme test (NvA-list) <br>- Speech intelligibility test with spatially separated sources <br>- Crescent of sound test, for sound localization <br>- Speech, Spatial and Qualities of hearing scale (SSQ)<br>- Health Utilities Index (HUI3)<br>- Glasgow Benefit Inventory (GBI)<br>- Abbreviated Profile of Hearing Aid Benefit (APHAB)<br>- Time Trade Off (TTO) <br>- Visual Analogue Scale (VAS)<br>- EuroQol5D<br>- Hospital Anxiety and Disorder Scale (HADS)<br>- Tinnitus Handicap Inventory (THI)<br>- Tinnitus Questionnaire (TQ)<br>- Tinnitus Burden Questionnaire (TBQ)<br>- Cost diary for cost utility analysis</p>