Objective Measures in Implantable Hearing Devices
This study is enrolling participants by invitation only.
Sponsor:
Nicolas Verhaert, MD
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Nicolas Verhaert, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01780025
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.
| Condition | Intervention |
|---|---|
|
Mixed Hearing Loss |
Behavioral: Auditory evoked potentials and audiometry Behavioral: Auditory evoked potentials |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss. |
Resource links provided by NLM:
Genetics Home Reference related topics:
nonsyndromic hearing loss
MedlinePlus related topics:
Hearing Disorders and Deafness
U.S. FDA Resources
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- auditory evoked potentials [ Time Frame: 1 - 3 - 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- speech audiometry [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Mixed hearing loss |
Behavioral: Auditory evoked potentials and audiometry
Behavioral: Auditory evoked potentials
Different protocols for audiometry and auditory evoked potentials
|
Detailed Description:
A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Mixed hearing loss
Criteria
Inclusion Criteria:
- adults
- mixed hearing loss
Exclusion Criteria:
- children
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780025
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780025
Locations
| Belgium | |
| UZ Leuven | |
| Leuven, Belgium, 3000 | |
Sponsors and Collaborators
Nicolas Verhaert, MD
Fund for Scientific Research, Flanders, Belgium
More Information
| Responsible Party: | Nicolas Verhaert, MD, M.D., Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01780025 History of Changes |
| Other Study ID Numbers: | S53530 |
| Study First Received: | January 28, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
Hearing Thresholds Coupling to the inner ear |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Loss, Mixed Conductive-Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 23, 2016