Distortion Product After Stapedotomy Surgery

Distorted Sound Perception Clinical Trial

Official title:

Subjektiv Verzerrter Höreindruck Nach Stapedotomie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245646
• Other study ID #: AH-RG_03_06_2014
• Status: Completed
• Start date: September 2014
• Est. completion date: May 1, 2016

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• indication for stapedotomy

• written consent given

Exclusion Criteria:

• not mentally able to give written consent

Related Conditions & MeSH terms

• Distorted Sound Perception

Locations

Country	Name	City	State
Switzerland	Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of distorted sound perception after stapedotomy 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.	7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
Secondary	Questionnaire on quality of hearing after Stapedotomy (APOSE)	Questionnaire	7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery