Distortion Product After Stapedotomy Surgery

Subjektiv Verzerrter Höreindruck Nach Stapedotomie

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02245646

Enrollment

Registered

2014-09-19

Start date

2014-09-30

Completion date

2016-05-01

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distorted Sound Perception

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

Inclusion criteria

* indication for stapedotomy * written consent given

Exclusion criteria

* not mentally able to give written consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results