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
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
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
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
NCT ID
NCT04623957
First Posted
November 3, 2020
Last Updated
November 9, 2020
Sponsor
Pansatori GmbH
Collaborators
Competence Center for Medical Devices GmbH
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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