Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

NCT04097041 | Withdrawn

• 1 other identifier: 43338
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Surgical Arm

ACTIVE COMPARATOR

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

Non-Surgery

ACTIVE COMPARATOR

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; Procedure: Non-Surgery

Interventions

Tympanomastoidectomy 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; Surgical Arm

Non-Surgery 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.

Non-Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Related Publications (1)

• 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.

  PMID: 23595093 RESULT

Related Links

• Sigmoid sinus dehiscence resurfacing as treatment for pulsatile tinnitus.

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Santa Maria, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: September 20, 2019
• Study Start: November 8, 2018
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2023
• Last Updated: September 20, 2019

Record last verified: 2019-09