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

Tinnitus, Subjective Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04623957
• Other study ID #: PANSATORI-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2020
• Source: Pansatori GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pansatori GmbH	Competence Center for Medical Devices GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory	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