Tinnitus
Conditions
Brief summary
The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.
Detailed description
This study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of the two groups. Depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.
Interventions
DEVICEDesyncra
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
OTHERCognitive Behavioral Therapy
Standard of Care
Sponsors
Desyncra, Inc.
VA National Center for Rehabilitative Auditory Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years * Primary and persistent tinnitus (6 months or longer in duration) * Tonal tinnitus * Dominant tinnitus frequency measured between 0.2 and 10 kHz * Tinnitus Questionnaire score * No current participation in other tinnitus therapy program * Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial * Able to pass the Tone Audibility Assessment with factor of 1.1
Exclusion criteria
* Secondary/somatic tinnitus due to a suspected underlying disease * Atonal, pulsatile, intermittent, or occasional tinnitus * Any hearing threshold \>70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1 * Any health or other problems that may prevent the person from completing the study procedures as determined by investigator * Participant reports current suicidal ideation and/or homicidal ideation * Use of medication which may trigger tinnitus \[e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin\] * Conductive hearing loss * Visible congenital or traumatic deformity of the ear * History of active drainage from the ear within the past 90 days * History of sudden or rapidly progressive hearing loss within the past 90 days * Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures * Previous use of Desyncra for Tinnitus Therapy System
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Questionnaire (TQ) | 24-weeks | 52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Cognitive Behavioral Therapy Standard of Care
Cognitive Behavioral Therapy: Standard of Care | 32 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Desyncra | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 26 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 30 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 24 Participants | 29 Participants | 53 Participants |
| Region of Enrollment United States | 29 participants | 32 participants | 61 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 32 |
| other Total, other adverse events | 0 / 29 | 0 / 32 |
| serious Total, serious adverse events | 0 / 29 | 0 / 32 |
Outcome results
Primary
Tinnitus Questionnaire (TQ)
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desyncra | Tinnitus Questionnaire (TQ) | 34.3 score on a scale | Standard Deviation 16.5 |
| Cognitive Behavioral Therapy | Tinnitus Questionnaire (TQ) | 35.1 score on a scale | Standard Deviation 13.7 |
Bayesian