Tinnitus, SubjectiveNCT04623957
Safety and Efficacy of Acupressure Applied Through ForgTin© in Patients With Tinnitus
A study testing ForgTin© in people with Tinnitus, Subjective, run by Pansatori GmbH.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- ForgTin©
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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
- Being tested
- ForgTin©
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ForgTin | Experimental | Patients randomized into group 1 will receive the ForgTin Medical Device for a duration of 3 months. Receives: Device: ForgTin© |
| No intervention | No intervention | Patients randomized into group 2 will receive no device for a duration of 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory
Tinnitus Impairment as assessed by the Tinnitus Handicap Inventory (THI)
Measured: Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pansatori GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Competence Center for Medical Devices GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623957
- Sponsor's protocol ID
- PANSATORI-001
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Acupressure Applied Through ForgTin© in Patients With Tinnitus
- ClinicalTrials.gov ID
- NCT04623957
- Acronym / sponsor ID
- PANSATORI-001
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Pansatori GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Competence Center for Medical Devices GmbH
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ForgTin | Experimental | Device: ForgTin©Patients randomized into group 1 will receive the ForgTin Medical Device for a duration of 3 months. |
| No intervention | No intervention | –Patients randomized into group 2 will receive no device for a duration of 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForgTin©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. | Device | ForgTin |
Primary outcome
Tinnitus Handicap Inventory
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ForgTin© in people with Tinnitus, Subjective, run by Pansatori GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (time frame: Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.