Tinnitus
Conditions
Keywords
tinnitus
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.
Interventions
OTHERPhysical Therapy
Individualized physiotherapy including exercises to be performed by the Veteran at home.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individualized Physiotherapy This study has 1 health-related intervention. Veterans with somatosensory tinnitus will receive individualized physiotherapy.
Physical Therapy: Individualized physiotherapy including exercises to be performed by the Veteran at home. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Individualized Physiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Tinnitus Functional Index
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).
Time frame: Baseline and 1 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individualized Physiotherapy | Tinnitus Functional Index | Baseline | 57.7 score on a scale | Standard Deviation 22.3 |
| Individualized Physiotherapy | Tinnitus Functional Index | 1 month follow-up | 39.6 score on a scale | Standard Deviation 26 |