Somatosensory Tinnitus RCT

Study Overview
=================
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.

Official Title
-----------------
Developing Tools and a Care Path for Somatosensory Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Other: Physical Therapy
* Other: Sound-based Therapy
* Other: Combination Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Physiotherapy<br>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<br>* Individuals randomized to this intervention will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.<br>* Other names: Individualized Physiotherapy;|
| Active Comparator: Sound-based Therapy<br>Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment. | Other: Sound-based Therapy<br>* Individuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.<br>* Other names: Audiology Therapy;|
| Experimental: Combination Therapy<br>Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy. | Other: Combination Therapy<br>* Individuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.<br>* Other names: Physical Therapy + Audiology Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TFI Score | 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). | Measured at at baseline; 8 and 12 weeks post-randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinnitus