Distortion Product After Stapedotomy Surgery

Completed

• Conditions: Distorted Sound Perception

• Registration Number: NCT02245646
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• indication for stapedotomy
• written consent given

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Exclusion Criteria

• not mentally able to give written consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of distorted sound perception after stapedotomy surgery	7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery	A psychoacoustic audiometric tests is performed; subjects are asked to press a button if the sound they hear is distorted, and this is tested at different frequencies and different level of loudness.

Secondary Outcome Measures

Name	Time	Method
Questionnaire on quality of hearing after Stapedotomy (APOSE)	7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery	Questionnaire

Trial Locations

Locations (1)

Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery; 🇨🇭 Zurich, Switzerland