Somatosensory Tinnitus Study

NCT ID: NCT03802513

Last Updated: 2022-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-04-01

Brief Summary

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Somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The Cleveland Clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.

Detailed Description

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Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a VA population.

Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in Veterans with tinnitus).

Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during Phase 1A.

Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.

Conditions

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Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized Physiotherapy

This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.

Group Type OTHER

Physical Therapy

Intervention Type OTHER

Individualized physiotherapy including exercises to be performed by the Veteran at home.

Interventions

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Physical Therapy

Individualized physiotherapy including exercises to be performed by the Veteran at home.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Veteran
* chronic tinnitus
* positive screen for somatosensory tinnitus

Exclusion Criteria

* Non-Veteran
* participation in new (\< 1 month) tinnitus management or treatment
* current participation in tinnitus research involving an intervention
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Theodoroff, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Portland, OR

Locations

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VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1I21RX003181-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

C3181-P

Identifier Type: -

Identifier Source: org_study_id

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