Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

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

Study Overview

• Status: Withdrawn
• Conditions: Tinnitus
• Intervention / Treatment: Procedure: Tympanomastoidectomy; Procedure: Non-Surgery

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: 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).
Active Comparator: 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.	Procedure: 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).; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Peter Santa Maria, MD, PhD, Stanford University

Publications and helpful links

General Publications

• Santa Maria PL. Sigmoid sinus dehiscence resurfacing as treatment for pulsatile tinnitus. J Laryngol Otol. 2013 Jul;127 Suppl 2:S57-9. doi: 10.1017/S0022215113000649. Epub 2013 Apr 18.

Helpful Links

• Sigmoid sinus dehiscence resurfacing as treatment for pulsatile tinnitus.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 8, 2018
• Primary Completion (Anticipated): August 26, 2022
• Study Completion (Anticipated): August 26, 2023

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 43338

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No