Distortion Product After Stapedotomy Surgery

NCT ID: NCT02245646

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-01

Brief Summary

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This study aims at capturing for the first time at which frequencies and sound intensities hearing distortions are perceived after successful stapedotomy surgery. Also, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Detailed Description

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If the stapes footplate is fixed in position, e.g. by otosclerosis, rather than being normally mobile, a conductive hearing loss results. This conductive hearing loss is usually compensated with hearing aids or through stapedotomy. During stapedotomy, the diseased stapes bone is removed and is replaced with a piston prosthesis that conveys the sound stimulus from the incus to the footplate of the removed stapes.

After surgery subjects sometimes state that the quality of sound is suboptimal, even though their hearing ability has improved significantly. Some subjects subjectively hear distorted sounds, which often disappear several weeks after surgery.

This study aims at capturing for the first time at which frequencies and sound intensities these distortions are perceived. Additionally, the portion of patients perceiving these sound distortions and the length of time over which the distortions occur are assessed.

Conditions

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Distorted Sound Perception

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

No indication for stapedotomy

No interventions assigned to this group

Distortion positive

Subjects after stapedotomy perceiving sound distortions

No interventions assigned to this group

Distortion negative

Subjects after stapedotomy not perceiving sound distortions.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* indication for stapedotomy
* written consent given

Exclusion Criteria

* not mentally able to give written consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Huber, Prof.

Role: STUDY_CHAIR

USZ

Locations

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Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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AH-RG_03_06_2014

Identifier Type: -

Identifier Source: org_study_id

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