Recruiting

Somatosensory

Sponsor:

VA Office of Research and Development

Code:

NCT05434637

Conditions

Tinnitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical Therapy

Sound-based Therapy

Combination Therapy

Study Details

Brief 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.

Conditions

Tinnitus

Study ID

NCT05434637

Start date

Nov 1, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

active comparator: Sound-based Therapy

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

experimental: Combination Therapy

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

Interventions

Physical 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.

Sound-based Therapy

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

Combination Therapy

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

Primary outcome measure

  • Change in Tinnitus Functional Index (TFI) Score [ Time Frame: Measured at at baseline; 8 and 12 weeks post-randomization ]

Central Contacts and Locations

Central contacts

Sarah Theodoroff, PhD

(503) 220-8262Sarah.Theodoroff@va.gov

Locations

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Sarah Theodoroff, PhD

(503) 220-8262Sarah.Theodoroff@va.gov

Principal Investigator:

Sarah Theodoroff, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Tinnitus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.