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Objective Measures in Implantable Hearing Devices

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ClinicalTrials.gov Identifier: NCT01780025
Recruitment Status : Unknown
Verified January 2013 by Nicolas Verhaert, MD, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Enrolling by invitation
First Posted : January 30, 2013
Last Update Posted : January 31, 2013
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Nicolas Verhaert, MD, Universitaire Ziekenhuizen Leuven

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Mixed Hearing Loss Behavioral: Auditory evoked potentials and audiometry Behavioral: 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.
Study Start Date : April 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Mixed hearing loss Behavioral: Auditory evoked potentials and audiometry Behavioral: Auditory evoked potentials
Different protocols for audiometry and auditory evoked potentials


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. auditory evoked potentials [ Time Frame: 1 - 3 - 6 months ]

Secondary Outcome Measures :
  1. speech audiometry [ Time Frame: 3 and 6 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01780025


Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Nicolas Verhaert, MD
Fund for Scientific Research, Flanders, Belgium
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nicolas Verhaert, MD, M.D., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01780025     History of Changes
Other Study ID Numbers: S53530
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Nicolas Verhaert, MD, 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