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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©
Sponsored by
Pansatori GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    November 3, 2020
    Last Updated
    November 9, 2020
    Sponsor
    Pansatori GmbH
    Collaborators
    Competence Center for Medical Devices GmbH
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    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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    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
    No
    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

    Learn more about this trial

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

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