Quality of Life With Bone Conduction Hearing Device

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT03864731

Collaborator

(none)

Enrollment

Location

Arm

46.2

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Conductive Hearing Loss	Device: Bone conduction device (ADHEAR)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Audiological Benefit and Improved Quality of Life in Patients With a Bone Conduction Device - a Randomized Controlled Trial

Actual Study Start Date :

Feb 25, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Bone conduction device - ADHEAR Patients will receive a hearing aid (ADHEAR). Hearing assessment will be carried out. Quality of life measurement will be carried out.	Device: Bone conduction device (ADHEAR) adhesive bone conduction device

Arm

Intervention/Treatment

Other: Bone conduction device - ADHEAR

Patients will receive a hearing aid (ADHEAR). Hearing assessment will be carried out. Quality of life measurement will be carried out.

Device: Bone conduction device (ADHEAR)

adhesive bone conduction device

Outcome Measures

Primary Outcome Measures

AQoL (Assessment of Quality of Life) Results [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unilateral and/or bilateral conductive hearing loss (CHL)
Conductive hearing loss >10 decibel on average
Subjective benefit from the device
Subjects aged 13 years or older
Capable of the German language
Willingness and ability to perform all tests required for the study
Signed, and dated informed consent before the start of any study specific procedure

Exclusion Criteria:

Pregnancy or breastfeeding
Patient uses a hearing aid or plans to acquire a hearing aid
Patient is intolerant of the materials as described by Manufacturer
Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
Patient presents with retrocochlear, or central auditory disorder.
any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MUW AKH	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Dominik Riss, MD, MUW

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dominik Riss, Principal Investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03864731

Other Study ID Numbers:

2087/2018

First Posted:

Mar 6, 2019

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hearing Loss

Hearing Loss, Conductive

Study Results

No Results Posted as of Apr 6, 2022