MUW AKH
Vienna, 1090, Austria
NCT Number: NCT03864731
The aim of this study is to compare the audiological and quality of life performance patients have with an ADHEAR (adhesive bone conduction device) compared to no hearing device.
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Notify Me13 year and older
All sexes
Interventional
Not applicable
Vienna, 1090, Austria
Patients will be recruited at the outpatient's department of the Medical University of Vienna - Otorhinolaryngology department. Patient will be asked to participate in the study when inclusion and exclusion criteria are met. Mostly patients scheduled for a surgery improving conductive hearing loss or scheduled for implantation of an implantable bone conduction hearing aid will be included in the study.
Patients who do not use a hearing aid and who are not planning on using a hearing aid meeting the inclusion and exclusion criteria will also be asked to participate in the study. After inclusion in the study patients will be asked to fill out two questionnaires (quality of life and hearing specific questionnaire). They will then be fitted with an ADHEAR device and undergo unaided and aided soundfield audiometry. Randomization will be carried out (Randomization ratio 1.4:1) and patients in the intervention group will keep the device for the following 4 months with one visit after the first probation time of one month. At the one month mark patients in the control group will be asked to fill out the two questionnaires. Patients in the control group will be asked to return to the department and fill out the three questionnaires (SSQ-12 (Speech Spatial and Hearing Questionnaire), AQoL(Assessment of Quality of Life) and In-house questionnaire). Further audiologic assessment will be carried out. At this appointment patients will be able to talk about their experiences in the probation period und easily terminate the study in case of insufficient improvement, pain, skin irritations or other issues. At the four month mark patients in both groups will be asked to return for audiologic assessment and for filling out the questionnaires.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
adhesive bone conduction device
Time frame: 4 months
The primary objective of this study is to evaluate, whether patients using ADHEAR have a significantly improved quality of life compared to patients not fitted with a device with the AQoL (Assessment of Quality of Life) questionnaire. It comprises 35 questions covering a multitude of quality of life aspects. Weighted utilities are generated using the algorithms provided on the AQoL website. Weighted utilities give a number between 0 and 1 as answer for every question. These sub scores are then presented.
Medical University of Vienna
Other
Audiological Benefit and Improved Quality of Life in Patients With a Bone Conduction Device - a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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