Study of Multifrequential Impedancemetry in Pulsatile Tinnitus (MADMAN)

March 5, 2026 updated by: University Hospital, Bordeaux
This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Bordeaux University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Unilateral or bilateral pulsatile tinnitus

Description

Inclusion Criteria:

  • Adult patient
  • Unilateral or bilateral pulsatile tinnitus
  • Pulsatile tinnitus > 1 month old
  • Affiliated or beneficiary of by social security system

Exclusion Criteria:

  • 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
  • Major protected
  • Abnormal tympanometry at 226 Hz
  • Presence of rotatory vertigo
  • Opposition to participation expressed by patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient with pulsatile tinnitus
Diagnostic test: multifrequential admittancemetry

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multifrequency admittancemetry
Time Frame: At Day 0 (inclusion)
G conductance peak width at 2000 Hz
At Day 0 (inclusion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compression maneuvers
Time Frame: At Day 0 (inclusion)
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.
At Day 0 (inclusion)
Evaluation of the effect of interventional radiology
Time Frame: up to 3 month after inclusion (M3)
Evaluation of the effect of interventional radiology procedures such as transverse sinus stenting on MFI values.
up to 3 month after inclusion (M3)
success of radiointerventional treatment
Time Frame: up to 3 month after inclusion (M3)
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).
up to 3 month after inclusion (M3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Actual)

September 4, 2025

Study Completion (Actual)

September 4, 2025

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2023/80

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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