Trial Outcomes & Findings for Somatosensory Tinnitus Study (NCT NCT03802513)

NCT ID: NCT03802513

Last Updated: 2022-05-17

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline and 1 month follow-up
• Results posted on: 2022-05-17

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Somatosensory Tinnitus Study

Baseline characteristics by cohort

Measure	Individualized Physiotherapy n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Individualized Physiotherapy n=9 Participants 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.
Tinnitus Functional Index Baseline	57.7 score on a scale Standard Deviation 22.3
Tinnitus Functional Index 1 month follow-up	39.6 score on a scale Standard Deviation 26.0

Adverse Events

Individualized Physiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

VA RR&D National Center for Rehabilitative Auditory Research

Phone: 503-220-8262

Email: sarah.theodoroff@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place