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Completed

NCT Number: NCT06290999

Study of Multifrequential Impedancemetry in Pulsatile Tinnitus

This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux University Hospital

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multifrequential admittancemetry

Diagnostic 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.

Primary outcomes

  1. Multifrequency admittancemetry

    Time frame: At Day 0 (inclusion)

    G conductance peak width at 2000 Hz

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: MADMAN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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