Safety and Efficacy of Acupressure Applied Through ForgTin© in Patients With Tinnitus

November 9, 2020 updated by: Pansatori GmbH
The main objective of this clinical trial is to evaluate the effectiveness and safety of the medical product ForgTin with regard to the impairment and change in the sensation of tinnitus (volume, frequency, psychological stress).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients (aged > 18 years)
  • Subjective tinnitus in one or both ears with intermittent or continuous symptoms with a duration of > 6 months

  • Tinnitus of Grade II, III or IV according to Mini-Tinnitus-Questionnaire (Mini-TF12):

    • Grade II (score of 8-12): moderately distressed
    • Grade III (score of 13-18): severely distressed
    • Grade III (score of 19-24): most severely distressed
  • If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
  • Provides written informed consent

Exclusion Criteria:

  • Vestibular schwannoma (acoustic neuroma)
  • Objective tinnitus
  • Any other tinnitus-related treatment
  • Ménière's Disease
  • Acute infections of the hearing system (acute otitis media, otitis externa, acute sinusitis)
  • Acute infections (acute otitis media, otitis externa, acute sinusitis)
  • Hearing aids or Cochlear Implants (CI)
  • Any current treatment with anticonvulsants, cortisone, tricyclic antidepressants
  • Other lesions (glomus tumors, meningiomas, adenomas, vascular lesions or neuro-vascular conflicts) detected by clinical assessment
  • Serious, concomitant disorder, including major depression, anxiety
  • Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives
  • Inability to comply with the protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ForgTin
Patients randomized into group 1 will receive the ForgTin Medical Device for a duration of 3 months.
Device: ForgTin©

The device is clamped behind the ear via two connected temple parts that pressed together around the connecting axis until an individual perfect wearing comfort is achieved. The pressure is adjusted so that the wearing of ForgTin© is barely noticed at all and may be changed at any time.

The aim is a slight pressure stimulation of clearly defined points behind the ear - thus wearing ForgTin© leads to a minimization of individual tinnitus noises.
No Intervention: No intervention
Patients randomized into group 2 will receive no device for a duration of 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory
Time Frame: Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7
Tinnitus Impairment as assessed by the Tinnitus Handicap Inventory (THI)
Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pansatori GmbH

Collaborators

Competence Center for Medical Devices GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 30, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANSATORI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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