Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma (ITG)
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|ClinicalTrials.gov Identifier: NCT02963896|
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : November 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Schwannoma||Drug: gentamicin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma With Pretreatment Prehabituation by Chemical Vestibular Ablation|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
intratympanic application of gentamicin 0.5 ml
intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml
Other Name: gentamycin
- The GBI questionnaire [ Time Frame: 2-3 years ]The GBI questionnaire consists of 18 questions. The response to each question is based on a five-point Likert scale, ranging from a large deterioration to a large improvement in health status. The GBI questionnaire is scored into a total score, and also three subscales: a general subscale (12 questions), a social support subscale (three questions), and a physical health subscale (three questions). Score ranges were calculated and varied from -100 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.
- The GHSI questionnaire [ Time Frame: 2-3 years ]The GHSI questionnaire contains of 18 questions; again, the response to each question is based on a five-point Likert scale ranging from high to low health status. It is also scored into a total score and three subscales: general, social, and physical health subscales. All these scores range from 0 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.
- The DHI questionnaire [ Time Frame: 2-3 years ]The DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.
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): NCT02963896
|Principal Investigator:||Zdeněk Čada, Ph.D.||Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University in Prague and Motol University Hospital, Postgraduate Medical School|