Pulsatile TinnitusMADMANNCT06290999
Study of Multifrequential Impedancemetry in Pulsatile Tinnitus
An observational study of Pulsatile Tinnitus, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulsatile Tinnitus
- What is being tested?
- multifrequential admittancemetry
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2024to 4 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Unilateral or bilateral pulsatile tinnitus
Who may be able to join
- Adult patient
- Unilateral or bilateral pulsatile tinnitus
- Pulsatile tinnitus > 1 month old
- Affiliated or beneficiary of by social security system
Who cannot join
- Otological surgery, excluding trans-tympanic aerators in childhood with closed eardrum
- Middle ear abnormality (any type of partial or total filling of the middle ear) noted on otoscopy or subsequent MRI scan
- Abnormal eardrums excluding tympanosclerosis
- Non-pulsatile tinnitus
- Conductive hearing loss with abolition of stapedial reflexes
- Minor patient
Show all 10Show fewer
- Major protected
- Abnormal tympanometry at 226 Hz
- Presence of rotatory vertigo
- Opposition to participation expressed by patient
Trial locations and contacts
1 site in 1 country.
About this study
This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.
Read the detailed description
The multifrequency admittancemetry is known to reflect several parameters of the middle ear and the external ear. More recently it appears to also reflect some parameters of the inner ear, such as the perilymph pressure. Furthermore, investigators do not know exactly the physiopathology of pulsatile tinnitus that are from veinous etiology. Modifications of the perilymphatic pressure could be implicated. Investigators intended to search for a relationship between these both theories.
Investigators will include every patient that consult to Ear, Nose and Throat unit of Bordeaux University Hospital with a pulsatile tinnitus trouble, and perform multifrequential admittancemetry. If a radio-surgical intervention is scheduled for a venous stenosis, the test will also be performed test after the surgery.
If there is no surgical intervention, no follow-up will be required.
- Conditions
- Pulsatile Tinnitus
- Being tested
- multifrequential admittancemetry
- Keywords
- Pulsatile Tinnitus, multifrequency admittancemetry
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifrequential admittancemetryDiagnostic test
Every participant of the study have to complete an Ear, Nose and Throat examination included a conventional audiometry, and a multifrequential admittancemetry.
if radio-interventional venous stenting is not indicated, an multifrequential admittancemetry will also be performed 3 months after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| patient with pulsatile tinnitus | Not described Receives: Diagnostic Test: multifrequential admittancemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multifrequency admittancemetry
G conductance peak width at 2000 Hz
Measured: At Day 0 (inclusion)
Secondary outcomes (3)
compression maneuvers
Evaluation of the effect of compression maneuvers on the width of the G 2000 peak of the IMF in venous or arterial pulsatile tinnitus, whether or not the maneuver is effective.
Measured: At Day 0 (inclusion)
Evaluation of the effect of interventional radiology
Evaluation of the effect of interventional radiology procedures such as transverse sinus stenting on MFI values.
Measured: up to 3 month after inclusion (M3)
success of radiointerventional treatment
Search for a predictive factor of success of radiointerventional treatment of venous pulsatile tinnitus: search for a threshold value of pre-operative G2000, separating two groups: success and non-success (groups defined by a THI (Tinnitus Handicap Index) divided by 2 in the success group).
Measured: up to 3 month after inclusion (M3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Jun 2024
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulsatile TinnitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290999
- Sponsor's protocol ID
- CHUBX 2023/80
- Acronym
- MADMAN
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multifrequential Impedancemetry in Pulsatile Tinnitus
- ClinicalTrials.gov ID
- NCT06290999
- Acronym / sponsor ID
- MADMAN / CHUBX 2023/80
- Conditions
- Pulsatile Tinnitus
- Keywords
- Pulsatile Tinnitus, multifrequency admittancemetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 4 Mar 2024 (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.
This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.
Detailed description
The multifrequency admittancemetry is known to reflect several parameters of the middle ear and the external ear. More recently it appears to also reflect some parameters of the inner ear, such as the perilymph pressure. Furthermore, investigators do not know exactly the physiopathology of pulsatile tinnitus that are from veinous etiology. Modifications of the perilymphatic pressure could be implicated. Investigators intended to search for a relationship between these both theories.
Investigators will include every patient that consult to Ear, Nose and Throat unit of Bordeaux University Hospital with a pulsatile tinnitus trouble, and perform multifrequential admittancemetry. If a radio-surgical intervention is scheduled for a venous stenosis, the test will also be performed test after the surgery.
If there is no surgical intervention, no follow-up will be required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with pulsatile tinnitus | – | Diagnostic Test: multifrequential admittancemetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Unilateral or bilateral pulsatile tinnitus
Key inclusion criteria (4 listed)
- Adult patient
- Unilateral or bilateral pulsatile tinnitus
- Pulsatile tinnitus > 1 month old
- Affiliated or beneficiary of by social security system
Key exclusion criteria (10 listed)
- Otological surgery, excluding trans-tympanic aerators in childhood with closed eardrum
- Middle ear abnormality (any type of partial or total filling of the middle ear) noted on otoscopy or subsequent MRI scan
- Abnormal eardrums excluding tympanosclerosis
- Non-pulsatile tinnitus
- Conductive hearing loss with abolition of stapedial reflexes
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 |
|---|---|---|
| multifrequential admittancemetryEvery participant of the study have to complete an Ear, Nose and Throat examination included a conventional audiometry, and a multifrequential admittancemetry. if radio-interventional venous stenting is not indicated, an multifrequential admittancemetry will also be performed 3 months after the procedure. | Diagnostic test | patient with pulsatile tinnitus |
Primary outcome
Multifrequency admittancemetry
Time frame: At Day 0 (inclusion)
G conductance peak width at 2000 Hz
3 secondary outcomes
compression maneuvers
Time frame: At Day 0 (inclusion)
Evaluation of the effect of interventional radiology
Time frame: up to 3 month after inclusion (M3)
success of radiointerventional treatment
Time frame: up to 3 month after inclusion (M3)
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 6 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulsatile Tinnitus, run by University Hospital, Bordeaux 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 4 inclusion and 10 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 6 Mar 2026. 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?
Multifrequency admittancemetry (time frame: At Day 0 (inclusion)). 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 6 Mar 2026.