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N/A N=61 Randomized Treatment

Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Tinnitus

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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