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RecruitingNCT05434637Updated Aug 24, 2026

Somatosensory Tinnitus RCT

An interventional study of Physical Therapy and Sound-based Therapy in Tinnitus, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Tinnitus

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Keywords

  • Tinnitus
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In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 72 is above the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Physical Therapy

  • Active comparator
    Sound-based Therapy

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

    Other: Sound-based Therapy

  • Experimental
    Combination Therapy

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

    Other: Combination Therapy

Interventions

  • OtherPhysical 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.

    Also known as: Individualized Physiotherapy

  • OtherSound-based Therapy

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

    Also known as: Audiology Therapy

  • OtherCombination Therapy

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

    Also known as: Physical Therapy + Audiology Therapy

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What researchers measure

Primary outcomes

  1. Change in Tinnitus Functional Index (TFI) Score

    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).

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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 43 months after the start.

Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 43 months is above that.

Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2022
First posted
Jun 28, 2022
StartActual
Nov 1, 2023
Primary completionEst.
Jun 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05434637
Responsible party
Sponsor
First posted
Jun 28, 2022
Start date
Nov 1, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 24, 2026

Study contacts

Sarah Theodoroff, PhD
Contact
Sarah.Theodoroff@va.gov
(503) 220-8262 ext. 51948
Sarah Theodoroff, PhD
principal investigator · VA Portland Health Care System, Portland, OR

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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