Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05856175
Other study ID # 202304
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date December 2025

Study information

Verified date May 2023
Source Beijing Friendship Hospital
Contact Pengfei Zhao, Prof.
Phone +8613811048563
Email zhaopengf05@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Venous tinnitus (VT) is seriously affecting the quality of life of five million patients in China. Bony wall reconstruction is the main treatment method, but the postoperative recurrence rate exceeds 30%, and the specific mechanism is unclear. Based on our previous work, a scientific hypothesis was put forward: the key to the recurrence of V T is pathologic remodeling of the peri-sinus bony wall mediated by the venous sinus morphology, blood flow, and pressure after surgical reconstruction. As a continuation of the National Natural Science Foundation of China-Youth Project, this project intends to combine multimodal imaging technology, multiphysics coupled numerical model and machine learning method to analyze analyze the data after bone wall reconstruction in multiple dimensions: ① To explore the influence of peri-sinus bony wall morphology, venous sinus morphology, intra-sinus blood flow, intra-sinus pressure, and cerebral perfusion on the recurrence of VT using ultra-high resolution CT, vessel wall MR, 4D Flow MR and ASL MR imaging technology; ② To explore the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of VT using multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields; ③ To determine the risk factors and their weights of VT recurrence using machine learning methods, and to establish a personalized surgical planning and prognostic evaluation models; Thus, to verify the hemodynamic and biomechanical mechanisms of VPT recurrence to achieve personalized and effectively treatment. This project may prevent and warn the recurrence of VPT after bony wall reconstruction.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with venous tinnitus, a rhythmic noise that follows the heart beating without external stimuli and can disappear or significantly reduce after compression of the affected side of the neck - the normal otoscopy - venous tinnitus patients with confirmed sigmoid sinus wall dehiscence with or without sigmoid sinuses enlargement, diverticula and transverse sinuses stenosis using dual-phase enhanced CT examination - preoperative DSA examination - bone wall reconstruction Exclusion Criteria: - contraindications for CT and MR Examination - tumor and arterial abnormalities

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the influence of peri-sinus bony wall morphology on the recurrence of pulsatile tinnitus using CT ultra-high resolution CT 2023.6.1-2025.12.31
Primary the influence of venous sinus morphology, intra-sinus blood flow, and intra-sinus pressure on the recurrence of pulsatile tinnitus using MRI 4D Flow MR imaging technology 2023.6.1-2025.12.31
Primary the influence of cerebral perfusion on the recurrence of pulsatile tinnitus using MRI ASL MR imaging technology 2023.6.1-2025.12.31
Primary the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of pulsatile tinnitus multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields 2023.6.1-2025.12.31
Primary the risk factors and their weights of pulsatile tinnitus recurrence Ensight, a post-processing software, was used to study the interaction between hemodynamic features and acoustic features with multivariate analysis and machine learning methods. 2023.6.1-2025.12.31
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
Not yet recruiting NCT06290999 - Study of Multifrequential Impedancemetry in Pulsatile Tinnitus
Terminated NCT02734576 - Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis N/A