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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06290999
Other study ID # CHUBX 2023/80
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT01855425 - Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose N/A
Completed NCT05441540 - Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus N/A
Not yet recruiting NCT05679271 - Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment N/A
Recruiting NCT05856175 - The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling
Terminated NCT02734576 - Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis N/A