Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

Tinnitus Clinical Trial

Official title:

Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04097041
• Other study ID #: 43338
• Status: Withdrawn
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: August 26, 2023

Study information

• Verified date: September 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 26, 2023
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Sigmoid sinus dehiscence resurfacing as treatment for pulsatile tinnitus.