Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

Not Applicable

Withdrawn

• Conditions: Tinnitus
• Interventions: Procedure: Tympanomastoidectomy; Procedure: Non-Surgery

• Registration Number: NCT04097041
• Lead Sponsor: Stanford University

Brief Summary

The investigators aim to study whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of venous pulsatile tinnitus.

Detailed Description

Currently there is no known treatments with efficacy for venous pulsatile tinnitus without any pathology. The investigators hope to learn that in surgery, resurfacing of the sigmoid sinus and jugular bulb (acoustic dampening) will eliminate symptoms such as pulsatile tinnitus in patients. The knowledge learned will significantly help treat and alleviate future patients that have pulsatile tinnitus.

The purpose of the study is to examine whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of pulsatile tinnitus in human subjects.

Study Timeline

• Study First Submitted: 2018-08-16
• Study Start: 2018-11-08
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-20
• Last Update Posted: 2019-09-20
• Primary Completion: 2022-08-26
• Study Completion: 2023-08-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Unilateral venous pulsatile tinnitus
• Visual Analogue score of severity >5

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Exclusion Criteria

• Surgery exclusion criteria
• Only hearing ear
• Unfit for surgery / anesthesia
• Visual Analogue score of severity 5 or less

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-Surgery	Tympanomastoidectomy	Non surgery arm - patient has audiological consult and fitting of masking device. The Patient has a routine follow up - H\&P, 2 weeks after masking fitting and then H\&P, Audiometry, Tympanometry over 12 months (3rd month, 6th month and 12th month). Patient cross over to change arms, at 6 months, if they have no resolution of symptoms.
Surgical Arm	Tympanomastoidectomy	Surgery arm - patient undergoes tympanomastoidectomy (approx 2 hour operation on ear and mastoid) where a local soft tissue flap is transferred to cover the sigmoid sinus, a cartilage and perichondrial graft is taken from the tragus to cover the jugular bulb).Patient has routine follow up - H\&P, 2 weeks after surgery and then H\&P, Audiometry and Tympanometry over 12 months post surgery (3rd month, 6th month and 12th month).
Non-Surgery	Non-Surgery	Non surgery arm - patient has audiological consult and fitting of masking device. The Patient has a routine follow up - H\&P, 2 weeks after masking fitting and then H\&P, Audiometry, Tympanometry over 12 months (3rd month, 6th month and 12th month). Patient cross over to change arms, at 6 months, if they have no resolution of symptoms.

Primary Outcome Measures

Name	Time	Method
Change from baseline in patient-reported tinnitus score	12 Months	Tinnitus severity rated on a 10-point Likert scale (range: 1-10; higher scores correspond to more severe symptoms).