Somatosensory Tinnitus RCT

NCT ID: NCT05434637

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-09-30

Brief Summary

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The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.

Detailed Description

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The purpose of this study is to: (1) develop a screening tool for somatosensory tinnitus and (2) perform a randomized clinical trial comparing different treatment approaches for somatosensory tinnitus. The investigators want to find out if individualized physical therapy, alone or in combination with audiology-based sound therapy, is beneficial for treating somatosensory tinnitus.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized Physiotherapy

Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type OTHER

Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Sound-based Therapy

Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Group Type ACTIVE_COMPARATOR

Sound-based Therapy

Intervention Type OTHER

Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Combination Therapy

Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.

Group Type EXPERIMENTAL

Combination Therapy

Intervention Type OTHER

Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.

Interventions

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Physical Therapy

Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Intervention Type OTHER

Sound-based Therapy

Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Intervention Type OTHER

Combination Therapy

Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.

Intervention Type OTHER

Other Intervention Names

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Individualized Physiotherapy Audiology Therapy Physical Therapy + Audiology Therapy

Eligibility Criteria

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Inclusion Criteria

* Constant, chronic tinnitus (6-months in duration)
* bothersome tinnitus based on TFI score and self-reported loudness
* able to modulate tinnitus perception with head, neck, and/or jaw maneuvers

Exclusion Criteria

* Middle ear pathology
* not a candidate for physical therapy
* injury to the temporomandibular area in past 3 months
* active pathology in the orofacial region
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 RECRUITING

Countries

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United States

Central Contacts

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Sarah Theodoroff, PhD

Role: CONTACT

(503) 220-8262 ext. 51948

Facility Contacts

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Sarah Theodoroff, PhD

Role: primary

503-220-8262 ext. 51948

Other Identifiers

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C3924-R

Identifier Type: -

Identifier Source: org_study_id

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