Somatosensory Tinnitus RCT

Part of paid clinical trials in Portland, Oregon.

Sponsor
VA Office of Research and Development
Study ID
NCT05434637
Status
Recruiting
Apply to this trial

Conditions

  • Tinnitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physical Therapy — OTHER
    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 — OTHER
    Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
  • Combination Therapy — OTHER
    Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in TFI Score [ Time Frame: Measured at at baseline; 8 and 12 weeks post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Sarah Theodoroff, PhD
[email protected]
503-220-8262
Sarah Theodoroff, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Portland Health Care System, Portland, OR· Portland, OR

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