Ear Middle ProblemsNCT04899011
Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life
An observational study of Ear Middle Problems, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands. CTN go throw middle ear between malleus and incus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ear Middle Problems
- What is being tested?
- Questionnaire
- How many people
- 214 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2021to 23 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with middle ear surgery
Who may be able to join
- Patient undergoing middle ear surgery
- Acceptation to participate
- under 18 years old, parental authorization.
Who cannot join
- Taste disturbance before surgery
- Patients with guardianship or tutelage measure
Trial locations and contacts
1 site in 1 country.
About this study
Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands.
CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery.
Read more
Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN.
We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms.
We will evaluate the Influence of type of CTN injury on taste disturbance.
- Conditions
- Ear Middle Problems
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire about taste and salivary disturbance before surgery, 10 days, 4 months and 1 year after surgery.
Questionnaires include characteristics of taste disturbance, and specific impact on quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Middle ear surgery | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life.
Taste and salivary disturbance will be measure with questionnaire before and during 1 year after middle ear surgery
Measured: 1 year
Secondary outcomes (2)
Influence of CTN injury type: stretch versus sectionned, influence of otologic desease
Measure with surgeon questionnaire
Measured: 1 day
Influence of use between endoscope or microscope surgery
Measure with surgeon questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start30 May 2021
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear Middle ProblemsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GUEVARA, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899011
- Sponsor's protocol ID
- 21IUFC01
- Status last verified
- Mar 2025
- First submitted
- 19 May 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life
- ClinicalTrials.gov ID
- NCT04899011
- Acronym / sponsor ID
- 21IUFC01
- Conditions
- Ear Middle Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 24 May 2021 (actual)
- 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.
Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands.
CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery.
Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN.
We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms.
We will evaluate the Influence of type of CTN injury on taste disturbance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle ear surgery | – | Other: Questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with middle ear surgery
Key inclusion criteria (3 listed)
- Patient undergoing middle ear surgery
- Acceptation to participate
- under 18 years old, parental authorization.
Key exclusion criteria (2 listed)
- Taste disturbance before surgery
- Patients with guardianship or tutelage measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire about taste and salivary disturbance before surgery, 10 days, 4 months and 1 year after surgery. Questionnaires include characteristics of taste disturbance, and specific impact on quality of life. | Other | Middle ear surgery |
Primary outcome
Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life.
Time frame: 1 year
Taste and salivary disturbance will be measure with questionnaire before and during 1 year after middle ear surgery
2 secondary outcomes
Influence of CTN injury type: stretch versus sectionned, influence of otologic desease
Time frame: 1 day
Influence of use between endoscope or microscope surgery
Time frame: 1 day
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 10 Mar 2025.
- Individual participant dataSharing planned: No
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.
Nicolas GUEVARA, Dr principal investigator
Centre Hospitalier Universitaire de Nice
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 Ear Middle Problems, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 2 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 10 Mar 2025. 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 France. 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?
Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life. (time frame: 1 year). 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 10 Mar 2025.