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

Primary Purpose

Tinnitus, Subjective

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ForgTin©

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ForgTin

No intervention

Arm Description

Patients randomized into group 1 will receive the ForgTin Medical Device for a duration of 3 months.

Patients randomized into group 2 will receive no device for a duration of 3 months.

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory

Tinnitus Impairment as assessed by the Tinnitus Handicap Inventory (THI)

Secondary Outcome Measures

Full Information

NCT ID

NCT04623957

First Posted

November 3, 2020

Last Updated

November 9, 2020

Sponsor

Pansatori GmbH

Collaborators

Competence Center for Medical Devices GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04623957

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 30, 2020 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pansatori GmbH

Collaborators

Competence Center for Medical Devices GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus, Subjective

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Patients will be randomized into two groups whereas both groups will experience the therapy during the course of the clinical investigation. Group 1 receives the intervention for a duration of three months. This Phase I is followed by a Washout period of one month and by a non-interventional phase (Phase II). Group 2 receives no initial treatment for a duration of three months (Phase I). This Phase I is followed by a Washout period of one month and by an interventional phase (Phase II). Phase III is introduced for both groups for ethical and motivational purposes and to observe potential long-term effects within Group 2.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ForgTin

Arm Type

Experimental

Arm Description

Patients randomized into group 1 will receive the ForgTin Medical Device for a duration of 3 months.

Arm Title

No intervention

Arm Type

No Intervention

Arm Description

Patients randomized into group 2 will receive no device for a duration of 3 months.

Intervention Type

Device

Intervention Name(s)

ForgTin©

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tinnitus Handicap Inventory

Description

Tinnitus Impairment as assessed by the Tinnitus Handicap Inventory (THI)

Time Frame

Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

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