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NCT Number: NCT05434637

Somatosensory Tinnitus RCT

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location status: Recruiting

Location contact

Sarah Theodoroff, PhD

CONTACT

[email protected]

(503) 220-8262 ext. 51948

Sarah Theodoroff, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Constant, chronic tinnitus (6-months in duration)
  • Bothersome tinnitus based on Tinnitus Functional Index (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

Treatment and study plan

Physical Therapy

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.

Other names: Individualized Physiotherapy

Sound-based Therapy

Other

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

Other names: Audiology Therapy

Combination Therapy

Other

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

Other names: Physical Therapy + Audiology Therapy

Primary outcomes

  1. Change in Tinnitus Functional Index (TFI) Score

    Time frame: Measured at at baseline; 8 and 12 weeks post-randomization

    The Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates treatment responsiveness (i.e., changes in functional effects of tinnitus over time). Total possible score ranges from 0-to-100 (scores >25 indicate tinnitus is a significant problem).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Theodoroff, PhD

CONTACT

[email protected]

(503) 220-8262 ext. 51948

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Developing Tools and a Care Path for Somatosensory Tinnitus

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2022
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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