Somatosensory Tinnitus RCT

VA Office of Research and Development

Status

Enrolling

Conditions

Tinnitus

Treatments

Other: Physical Therapy

Other: Combination Therapy

Other: Sound-based Therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05434637

C3924-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 3 patient groups

Individualized Physiotherapy

Experimental group

Description:

Individuals randomized to this group will receive physical therapy, personalized for the participant's specific needs, and include exercises to be performed at home.

Treatment:

Other: Physical Therapy

Sound-based Therapy

Active Comparator group

Description:

Individuals randomized to this group will receive sound-based therapy, consistent with an audiology-based standard of care treatment.

Treatment:

Other: Sound-based Therapy

Combination Therapy

Experimental group

Description:

Individuals randomized to this group will receive both individualized physical therapy and sound-based therapy.