Distorted Sound PerceptionNCT02245646
Distortion Product After Stapedotomy Surgery
An observational study of Distorted Sound Perception, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Distorted Sound Perception
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to 1 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Control group: Healthy volunteers are recruited by flyers that are displayed in the waiting zones of the ENT clinic. Subjects with stapedotomy: Patients are being asked by the examining MD as soon as the indication for stapedotomy is proven.
Who may be able to join
- indication for stapedotomy
- written consent given
Who cannot join
- not mentally able to give written consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University Hospital, Division of Otorhinolaryngology, Head and Neck Surgery
Zurich, 8091
About this study
Official title: Subjektiv Verzerrter Höreindruck Nach Stapedotomie
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.
Read the 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.
- Conditions
- Distorted Sound Perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No indication for stapedotomy | |
| Distortion positive | Subjects after stapedotomy perceiving sound distortions | |
| Distortion negative | Subjects after stapedotomy not perceiving sound distortions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
Secondary outcomes (1)
Questionnaire on quality of hearing after Stapedotomy (APOSE)
Questionnaire
Measured: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distorted Sound PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Alexander Huber, Prof., Study chair, USZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245646
- Sponsor's protocol ID
- AH-RG_03_06_2014
- Status last verified
- May 2024
- First submitted
- 10 Sep 2014
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjektiv Verzerrter Höreindruck Nach Stapedotomie
- ClinicalTrials.gov ID
- NCT02245646
- Acronym / sponsor ID
- AH-RG_03_06_2014
- Conditions
- Distorted Sound Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Sep 2014
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –No indication for stapedotomy |
| Distortion positive | – | –Subjects after stapedotomy perceiving sound distortions |
| Distortion negative | – | –Subjects after stapedotomy not perceiving sound distortions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Control group: Healthy volunteers are recruited by flyers that are displayed in the waiting zones of the ENT clinic. Subjects with stapedotomy: Patients are being asked by the examining MD as soon as the indication for stapedotomy is proven.
Key inclusion criteria (2 listed)
- indication for stapedotomy
- written consent given
Key exclusion criteria (1 listed)
- not mentally able to give written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of distorted sound perception after stapedotomy surgery
Time frame: 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.
1 secondary outcome
Questionnaire on quality of hearing after Stapedotomy (APOSE)
Time frame: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Huber, Prof. study chair
USZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distorted Sound Perception, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of distorted sound perception after stapedotomy surgery (time frame: 7 to 14 days post surgery; 21 to 25 days post surgery; 3, 6 and 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.