TinnitusPhase 4RRLNCT01435317
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
A Phase 4 study testing ANM T30 CR®-System in people with Tinnitus, run by ANM Adaptive Neuromodulation GmbH at 23 sites in Germany.
Trial summary
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- ANM T30 CR®-System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 23 sitesGermany
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 4
- 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
Main Inclusion Criteria:
- symptomatic subjective tonal chronical (> 3 months) tinnitus
- <60dB hearing loss
- men and women ≥18 years old
Main Exclusion Criteria:
- serious neurologic
- psychiatric or internistic disease
- objective tinnitus
- Morbus Menière
- craniomandibular triggered tinnitus
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Germany23 sites
Dr. med. Mueller
Augsburg, 86167
Dr. med. Jan Loehler
Bad Bramstedt, 24576
Praxisverbund Berlin
Berlin, 10119
Dr. med. Daniel Osterland
Berlin, 10711
Dres. med. Bodlien/Lingner/Kassuhn
Braunschweig, 38100
Praxis HNO Koeln Nord
Cologne, 50735
Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
Frankfurt, 60594
Dr. med. Fleissner
Freiburg im Breisgau, 79098
EuromedClinic
Fürth, 90763
Dr. med. Hegemann-Gaertner
Grevenbroich, 41515
Dipl.-Med. Kathrin Stoelzer
Halle, 06108
Dr. med. Hahbrock
Koblenz, 56068
Dr. med. Wichmann
Krefeld, 47807
Roemerwallklini Gmbh
Mainz, 55131
HNO-Gemeinschaftspraxis im Zentrum
Mannheim, 68161
Dr .med. Tatjana von Stackelberg
Meerbusch, 40667
Dr. med. Ullmann
Melsungen, 34212
Dr. med. Wurzer
München, 80333
Dres. med. Bergmann und Davies
Nürtingen, 72622
Dr. med Uwe Brinkmann
Oelde, 59302
Dr. med. Huegelschaeffer
Philippsburg, 76661
Dr. med. Axel Roesler
Radevormwald, 42477
Dres. med. Ramming und Waller
Schweinfurt, 97421
About this study
Official title: Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.
- Identification of early indicators for therapy success
- Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
- Representative set of safety data in a broad patient spectrum
- Measurement of tinnitus burden (TBF-12 Questionnaire)
- Generation of longterm compliance data
- Conditions
- Tinnitus
- Being tested
- ANM T30 CR®-System
- Keywords
- Acoustic CR®-neuromodulation, ANM T30 CR®-System
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANM T30 CR®-SystemDevice
Stimulation for 4-6h/day for a time of 1 year
| Study group | Role | What they receive |
|---|---|---|
| standard | Experimental | Standard treatment with the ANM T30 CR®-System Receives: Device: ANM T30 CR®-System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of TBF-12 Score or CGI Score
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
Measured: 12 months
Secondary outcomes (6)
NRS loudness and annoyance (0-100)
Measured: 0.5, 1, 2, 3, 6, 9, 12 months
Tinnitus-freedom
Measured: 3,6,9,12 months
Compliance
Questioning if the specified application was kept.
Measured: 0.5,1,3,6,9,12 months
Alteration of tinnitus
Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.
Measured: 0.5,1,2,3,6,9,12 months
Audiogram for hearing loss change
Measured: 3,12 months
TBF-12
Measured: 3,6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANM Adaptive Neuromodulation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Responsible party
- Sponsor
- Investigators
- Uwe Brinkmann, Dr. med., Principal investigator, HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435317
- Sponsor's protocol ID
- NCT2011-08-26
- Acronym
- RRL
- Status last verified
- Jul 2014
- First submitted
- 31 Aug 2011
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus
- ClinicalTrials.gov ID
- NCT01435317
- Acronym / sponsor ID
- RRL / NCT2011-08-26
- Conditions
- Tinnitus
- Keywords
- Acoustic CR®-neuromodulation, ANM T30 CR®-System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ANM Adaptive Neuromodulation GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Sep 2011 (estimated)
- 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.
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.
- Identification of early indicators for therapy success
- Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
- Representative set of safety data in a broad patient spectrum
- Measurement of tinnitus burden (TBF-12 Questionnaire)
- Generation of longterm compliance data
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standard | Experimental | Device: ANM T30 CR®-SystemStandard treatment with the ANM T30 CR®-System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ANM T30 CR®-SystemStimulation for 4-6h/day for a time of 1 year | Device | standard |
Primary outcome
Improvement of TBF-12 Score or CGI Score
Time frame: 12 months
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
6 secondary outcomes
NRS loudness and annoyance (0-100)
Time frame: 0.5, 1, 2, 3, 6, 9, 12 months
Tinnitus-freedom
Time frame: 3,6,9,12 months
Compliance
Time frame: 0.5,1,3,6,9,12 months
Alteration of tinnitus
Time frame: 0.5,1,2,3,6,9,12 months
Audiogram for hearing loss change
Time frame: 3,12 months
TBF-12
Time frame: 3,6,9,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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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.
Uwe Brinkmann, Dr. med. principal investigator
HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ANM T30 CR®-System in people with Tinnitus, run by ANM Adaptive Neuromodulation GmbH at 23 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of TBF-12 Score or CGI Score (time frame: 12 months). 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 11 Jul 2014.