Somatosensory Tinnitus RCT

Not Applicable

Recruiting

• Conditions: Tinnitus
• Interventions: Other: Sound-based Therapy; Other: Combination Therapy; Other: Physical Therapy

• Registration Number: NCT05434637
• Lead Sponsor: VA Office of Research and Development

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.

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.

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Study Start: 2023-11-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Constant, chronic tinnitus (6-months in duration)
• bothersome tinnitus based on 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sound-based Therapy	Sound-based Therapy	Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Combination Therapy	Combination Therapy	Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.
Individualized Physiotherapy	Physical Therapy	Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Primary Outcome Measures

Name	Time	Method
Change in TFI Score	Measured at at baseline; 8 and 12 weeks post-randomization	The 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).

Trial Locations

Locations (1)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States