Study of Multifrequential Impedancemetry in Pulsatile Tinnitus

Pulsatile Tinnitus Clinical Trial

— MADMAN  

Official title:

Study of Multifrequential Impedancemetry in Pulsatile Tinnitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290999
• Other study ID #: CHUBX 2023/80
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: Balthazar CROC
• Phone: 0556795609
• Email: balthazar.croc[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulsatile Tinnitus
• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multifrequency admittancemetry	G conductance peak width at 2000 Hz	At Day 0 (inclusion)
Secondary	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.	At Day 0 (inclusion)
Secondary	Evaluation of the effect of interventional radiology	Evaluation of the effect of interventional radiology procedures such as transverse sinus stenting on MFI values.	up to 3 month after inclusion (M3)
Secondary	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).	up to 3 month after inclusion (M3)