Study of Multifrequential Impedancemetry in Pulsatile Tinnitus

Recruiting

• Conditions: Pulsatile Tinnitus
• Interventions: Diagnostic Test: multifrequential admittancemetry

• Registration Number: NCT06290999
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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 Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Study Start: 2024-06-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-12-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with pulsatile tinnitus	multifrequential admittancemetry	-

Primary Outcome Measures

Name	Time	Method
Multifrequency admittancemetry	At Day 0 (inclusion)	G conductance peak width at 2000 Hz

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effect of interventional radiology	up to 3 month after inclusion (M3)	Evaluation of the effect of interventional radiology procedures such as transverse sinus stenting on MFI values.
success of radiointerventional treatment	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).
compression maneuvers	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.

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France