N/A
N=61
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT03022084 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Tinnitus Questionnaire (TQ) — 34.3; 35.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Desyncra (Device); Cognitive Behavioral Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA National Center for Rehabilitative Auditory Research
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Questionnaire (TQ) |
34.3; 35.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03022084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.