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

Pansatori

Status: Unknown

Conditions: Tinnitus, Subjective

Treatments: Device: ForgTin©

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04623957

PANSATORI-001

Details and patient eligibility

About

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).

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

ForgTin

Experimental group

Description:

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

Treatment:

Device: ForgTin©

No intervention

No Intervention group

Description:

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