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

Not Applicable

• Conditions: Tinnitus, Subjective
• Interventions: Device: ForgTin©

• Registration Number: NCT04623957
• Lead Sponsor: Pansatori GmbH

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-09
• Last Update Submitted: 2020-11-09
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Study Start: 2020-11-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory	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)