Day-case versus inpatient cochlear implantation: a randomized controlled trial.
- Conditions
- deafnesssevere to profound bilateral sensorineural hearing loss10019243
- Registration Number
- NL-OMON44709
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Age >= 18 years;
Severe to profound bilateral 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 outpatient setting;
Quick access to communication and transportation in case of any complications;
Good understanding of the Dutch language.
Severe to profound pre-lingual sensorineural hearing loss;
Severe to profound unilateral sensorineural hearing loss;
Previous cochlear implantation;
Aberrant (cochlear) anatomy on CT-scan or chronic ear infection;
General health does not allow general anesthesia in an outpatient setting;
Disability that could interfere with audiologic evaluation and/or questionnaire fulfillment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure is general quality of life measured by the Health<br /><br>Utility Index - Mark 3.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are disease-specific quality of life, complications<br /><br>and cost-effectiveness.</p><br>