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NCT05374421

Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

Terminated NA Results posted Last updated 12 March 2024
What this trial tests

NA trial testing Erchonia® THL™ in Tinnitus in 23 participants. Terminated before completion.

Timeline
10 May 2022
Primary endpoint
9 December 2022
9 December 2022

Quick facts

Lead sponsorErchonia Corporation
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment23
Start date10 May 2022
Primary completion9 December 2022
Estimated completion9 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Erchonia Corporation — full company profile →

Who can join

18 and older, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline to Study Endpoint in the Tinnitus Functional Index (TFI) Primary · Baseline and 4 weeks

The Tinnitus Functional Index (TFI) has been highly recommended to be used in both clinical and research settings for tinnitus measurement (Meikle et al., 2011). The self-report questionnaire, consists of 25 items with a response option on an 11-point Likert scale from 0-10. The calculation of overall TFI score is as follows: (1) Sum all valid answers. (2) Divide by the number of questions for which the sum of the valid answers was based to yield the respondent's mean item score. (3) Multiply by 10 to attain the respondent's overall TFI score (0-100 range). Total TFI score can be categorized a

GroupValue95% CI
Erchonia® THL™-8.96± 15.53
Placebo Laser-2.8± 5.7

Sponsor's own description

The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Experience of tinnitus in adults who have severe-to-profound hearing loss: A scoping review.
    Alzahrani L, Sereda M, Chamouton CS, Haider H, et al · · 2022 · PMID 36388182 · DOI 10.3389/fneur.2022.1004059

Verify or expand the search:

Other recruiting trials for Tinnitus

Currently open trials in the same condition.

Other Erchonia Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05374421.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing