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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

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.Check my eligibility
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.See study design
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.
Select...
I am not eligible for physical therapy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in TFI Score

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,907 Total Patients Enrolled
6 Trials studying Tinnitus
498 Patients Enrolled for Tinnitus
Sarah Theodoroff, PhDPrincipal InvestigatorVA Portland Health Care System, Portland, OR
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Tinnitus
10 Patients Enrolled for Tinnitus

Media Library

Combination Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05434637 — N/A
Tinnitus Research Study Groups: Individualized Physiotherapy, Sound-based Therapy, Combination Therapy
Tinnitus Clinical Trial 2023: Combination Therapy Highlights & Side Effects. Trial Name: NCT05434637 — N/A
Combination Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05434637 — N/A
Tinnitus Patient Testimony for trial: Trial Name: NCT05434637 — N/A
~48 spots leftby Jun 2026
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