Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2023-08-26

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Arm

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).

Group Type ACTIVE_COMPARATOR

Tympanomastoidectomy

Intervention Type PROCEDURE

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).

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.

Group Type ACTIVE_COMPARATOR

Tympanomastoidectomy

Intervention Type PROCEDURE

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).

Non-Surgery

Intervention Type PROCEDURE

Screening performed at outpatient clinic after consultation for management of venous pulsatile tinnitus. Consent and formal recruitment into study performed at preoperative visit or at audiological visit.

The masking device is a hearing aid that provides sound that is aimed to negate the internal sound from the pulsatile tinnitus. Almost all hearing aid can be converted to a masking device for tinnitus. It is externally worn on the ear and provides sound at a desired volume. The benefits of wearing the masking device are that it may reduce the volume of the pulsatile tinnitus. As it is worn on the external ear and is not invasive there are minimal risks but potential risks could include irritation of the external ear and discomfort from wearing.

Interventions

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Tympanomastoidectomy

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).

Intervention Type PROCEDURE

Non-Surgery

Screening performed at outpatient clinic after consultation for management of venous pulsatile tinnitus. Consent and formal recruitment into study performed at preoperative visit or at audiological visit.

The masking device is a hearing aid that provides sound that is aimed to negate the internal sound from the pulsatile tinnitus. Almost all hearing aid can be converted to a masking device for tinnitus. It is externally worn on the ear and provides sound at a desired volume. The benefits of wearing the masking device are that it may reduce the volume of the pulsatile tinnitus. As it is worn on the external ear and is not invasive there are minimal risks but potential risks could include irritation of the external ear and discomfort from wearing.

Intervention Type PROCEDURE