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Surgery Compared to Masking Device for Venous Pulsatile Tinnitus

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ClinicalTrials.gov Identifier: NCT04097041
Recruitment Status : Withdrawn (Change in availability of investigators/participants)
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Santa Maria, Stanford University

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.

Condition or disease Intervention/treatment Phase
Tinnitus Procedure: Tympanomastoidectomy Procedure: Non-Surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model 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). 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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery Compared to Masking Device for Venous Pulsatile Tinnitus
Estimated Study Start Date : November 8, 2018
Estimated Primary Completion Date : August 26, 2022
Estimated Study Completion Date : August 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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.





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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097041


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Peter Santa Maria, MD, PhD Stanford University

Additional Information:
Publications of Results:
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Responsible Party: Peter Santa Maria, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04097041     History of Changes
Other Study ID Numbers: 43338
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms