Day-case cochlear implantation compared to in-patient cochlear implantation in patients with severe to profound hearing loss.
Recruiting
- Conditions
- Severe to profound sensorineural hearing loss.
- Registration Number
- NL-OMON26971
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
• Age ≥ 18;
• Severe to profound post-lingual sensorineural hearing loss defined as > 70 dB nHL on pure-tone audiometry in the range of 500, 1000 and 2000 Hz;
• Willingness and ability to participate in all scheduled procedures outlined in the research protocol;
• General health allowing general anesthesia in an out-patient setting;
• Quick access to communication and transportation in case of any complications;
• Good understanding of the Dutch language.
Exclusion Criteria
• Severe to profound pre-lingual sensorineural hearing loss;
• Previous cochlear implantation;
• Aberrant (cochlear) anatomy on CT-scan or chronic ear infection;
• Disability that could interfere with questionnaire fulfillment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method General quality of life measured by the Health Utilities Index - Mark III at three weeks postoperatively.
- Secondary Outcome Measures
Name Time Method • Complications;<br>• Disease specific quality of life using the Glasgow Health Status Questionnaire and the Glasgow Benefit Inventory;<br>• General quality of life using the EuroQol-5D;<br>• Tinnitus using the Tinnitus Handicap Inventory, Tinnitus Questionnaire and Utrecht Tinnitus Burden Questionnaire for severity of tinnitus;<br>• Vertigo using the Utrecht Vertigo Burden Questionnaire;<br>• Cost-utility analysis using a costs diary.