Somatosensory Tinnitus Study

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Other: Physical Therapy

• Registration Number: NCT03802513
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The Cleveland Clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.

Detailed Description

Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a VA population.

Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in Veterans with tinnitus).

Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during Phase 1A.

Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-12-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-01
• Results First Submitted: 2022-02-23
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Results First Posted: 2022-05-17
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Veteran
• chronic tinnitus
• positive screen for somatosensory tinnitus

Exclusion Criteria

• Non-Veteran
• participation in new (< 1 month) tinnitus management or treatment
• current participation in tinnitus research involving an intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individualized Physiotherapy	Physical Therapy	This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.

Primary Outcome Measures

Name	Time	Method
Tinnitus Functional Index	Baseline and 1 month follow-up	The TFI is a 25-item questionnaire that measures the functional effects of tinnitus. 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