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

NCT04623957 | Unknown

• 1 other identifier: PANSATORI-001
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ForgTin

EXPERIMENTAL

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

Device: ForgTin©

No intervention

NO INTERVENTION

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

Interventions

ForgTin© DEVICE

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.

ForgTin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Provides written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Pansatori GmbH: lead
• Competence Center for Medical Devices GmbH: collaborator

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 10, 2020
• Study Start: November 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 10, 2020

Record last verified: 2020-11