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Multimodal Therapy for Tinnitus

N/A

Recruiting

Led By Sarah Theodoroff, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

bothersome tinnitus based on TFI score and self-reported loudness

Constant, chronic tinnitus (6-months in duration)

Must not have

Middle ear pathology

Active pathology in the orofacial region

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at at baseline; 8 and 12 weeks post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a possible new treatment for a type of tinnitus caused by neck movement.

Who is the study for?

This trial is for people who have had constant, bothersome tinnitus for at least six months and can change the perception of their tinnitus by moving their head, neck, or jaw. It's not suitable for those with middle ear problems, recent injuries to the jaw area, or active issues in the mouth and face.

What is being tested?

The study tests three treatments: physical therapy alone, sound-based therapy alone, and a combination of both. The goal is to see which method best alleviates somatosensory tinnitus—where symptoms are affected by certain movements.

What are the potential side effects?

Potential side effects may include discomfort from physical therapy maneuvers or increased ringing during sound-based treatment. However, these therapies are generally considered low-risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tinnitus that is loud and bothers me.

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I have had constant ringing in my ears for over 6 months.

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I have tinnitus that bothers me and is loud according to my own report and TFI score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a middle ear condition.

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I have an active disease in my mouth or face.

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I am not eligible for physical therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at at baseline; 8 and 12 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at at baseline; 8 and 12 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at at baseline; 8 and 12 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in TFI Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Individualized PhysiotherapyExperimental Treatment1 Intervention

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 II: Combination TherapyExperimental Treatment1 Intervention

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

Group III: Sound-based TherapyActive Control1 Intervention

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

0 / 6Eligibility criteria met