Somatosensory Tinnitus RCT
ConditionTinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Middle ear pathology
Not a candidate for physical therapy
Injury to the temporomandibular area in past 3 months
Active pathology in the orofacial region
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Therapy
Other interventionIndividuals 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 interventionIndividuals randomized to this intervention will receive sound-based therapy, consistent with an audiology-based standard of care treatment.
Combination Therapy
Other interventionIndividuals randomized to this intervention will receive both individualized physical therapy and sound-based therapy.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Individualized PhysiotherapyExperimental treatment 1 intervention
Group B: Sound-based TherapyActive comparator 1 intervention
Group C: Combination TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Tinnitus Functional Index (TFI) Score
The Tinnitus Functional Index (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).
Time frame
Measured at at baseline; 8 and 12 weeks post-randomizationSponsors and contacts
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Source ClinicalTrials.gov