Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

Stanford University

Status: Withdrawn

Conditions: Tinnitus

Treatments: Procedure: Non-Surgery; Procedure: Tympanomastoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04097041

43338

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Surgical Arm

Active Comparator group

Description:

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).

Treatment:

Procedure: Tympanomastoidectomy

Non-Surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Tympanomastoidectomy

Procedure: Non-Surgery