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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at at baseline; 8 and 12 weeks post-randomization
Awards & highlights

Study 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.
Select...
I have tinnitus that bothers me and is loud according to my own report and TFI score.
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I can change my tinnitus sound by moving my head, neck, or jaw.

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
1,609 Previous Clinical Trials
3,306,531 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this experiment accessible to participants?

"As evidenced on clinicaltrials.gov, this particular research endeavour is no longer actively seeking participants. It was first posted in November 6th 2023 and the last update occurred June 22nd 2022. Luckily for those interested in participating trials of a similar nature, there are currently 45 other studies that require volunteers."

Answered by AI

Who else is applying?

What state do they live in?
California
Washington
Oregon
Other
How old are they?
18 - 65
65+
What site did they apply to?
VA Portland Health Care System, Portland, OR
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

What questions have other patients asked about this trial?

when could we start? Are drugs involved? Sound therapy? PT? Will folks be reimbursed for travel costs?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Because the tinnitus has become painful and constant. This is an on going problem and wonder if this will help.
PatientReceived 1 prior treatment
Just hoping for relief from persistent ringing in my ears. I’ve had the noise for over 8 years, I want to help make it stop.
PatientReceived 2+ prior treatments
I have tinnitus 24/7 I wake up 4-5 times a night. It's very difficult to live day to day with this condition.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. VA Portland Health Care System, Portland, OR: < 24 hours
Average response time
  • < 2 Days
~48 spots leftby Jun 2026