Trial Outcomes & Findings for Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus (NCT NCT03022084)
NCT ID: NCT03022084
Last Updated: 2020-07-13
Results Overview
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
24-weeks
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
Desyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
|
Cognitive Behavioral Therapy
Standard of Care
Cognitive Behavioral Therapy: Standard of Care
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Desyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
|
Cognitive Behavioral Therapy
Standard of Care
Cognitive Behavioral Therapy: Standard of Care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
Baseline characteristics by cohort
| Measure |
Desyncra
n=29 Participants
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
|
Cognitive Behavioral Therapy
n=32 Participants
Standard of Care
Cognitive Behavioral Therapy: Standard of Care
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24-weeks52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
Outcome measures
| Measure |
Desyncra
n=27 Participants
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Desyncra: This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
|
Cognitive Behavioral Therapy
n=29 Participants
Standard of Care
Cognitive Behavioral Therapy: Standard of Care
|
|---|---|---|
|
Tinnitus Questionnaire (TQ)
|
34.3 score on a scale
Standard Deviation 16.5
|
35.1 score on a scale
Standard Deviation 13.7
|
Adverse Events
Desyncra
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy
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
Dr. James Henry
VA RR&D National Center for Rehabilitative Auditory Research
Phone: 503-220-8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place