TinnitusNCT02669069
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
A study testing PS1, PS2 and PS3 in people with Tinnitus, run by Neuromod Devices Ltd. at 2 sites in 2 countries.
Trial summary
This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- PS1, PS2 and PS3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Jun 2016to 30 Jan 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- The ability to read and understand English/German
- Willing and able to provide informed consent
- Willing to commit to the full duration of the study
- Have been experiencing tinnitus 3 months to 5 years
- Experiencing subjective tinnitus
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- Baseline Tinnitus Handicap Inventory (THI) score of 28 to 76 points
- Baseline Minimum Masking Level (MML) of 20 to 80 dBHL
- Maximum AC pure-tone audiometry hearing loss of 80 dB HL at any test frequency in the range of 2 to 8 kHz or of 40 dB HL in the range of 250 to 1000 Hz either unilaterally or bi-laterally
Who cannot join
- If participant has been diagnosed with objective tinnitus
- Commenced usage of hearing aid within the last 90 days
- Cases where pulsatility is the dominant feature of tinnitus
- Patients whose tinnitus cannot be masked during MML assessment
- Meniere's disease
- Significantly severe Loudness Discomfort Level (LDL), <30 dB SL
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- Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) scores greater than 120
- Diagnosed with somatic tinnitus resulting from head or neck injury
- Temporomandibular Joint Disorder (TMJ)
- Current or previous involvement in medico-legal cases
- Pregnancy
- Oral piercings
- Neurological conditions that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ENT consultant
- Severe cognitive impairment based on Mini Mental State Examination (MMSE), less than 20
- Pacemakers or other electro-active implanted devices
- Have used Neuromod Devices products in the past
- Participants currently prescribed drugs for a Central Nervous System pathology, i.e. epilepsy, Multiple Sclerosis (MS), Parkinson's, bi-polar disorder.
- The site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above
- Self-reporting episodes of Auditory hallucinations
- Abnormal Otoscopy as assessed by the Audiologist, including active Otitis Media, perforation and hearing loss that is identified as completely conductive
- Abnormal Tympanometry as assessed by the Audiologist
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
Read the detailed description
Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.
- Conditions
- Tinnitus
- Being tested
- PS1, PS2, PS3
- Keywords
- Bi-modal neuromodulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS1Device
Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones.
PS2Device
Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.
PS3Device
Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.
| Study group | Role | What they receive |
|---|---|---|
| PS1 | Active comparator | Not described Receives: Device: PS1 |
| PS2 | Active comparator | Not described Receives: Device: PS2 |
| PS3 | Active comparator | Not described Receives: Device: PS3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Functional Index
Measured: Between baseline and 12 weeks
Tinnitus Handicap Inventory
Measured: Between baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start27 Jun 2016
- Primary completion31 Jul 2017
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromod Devices Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Regensburg
- Responsible party
- Sponsor
- Investigators
- Mr. Brendan Conlon, Principal investigator, St. James's Hospital, IrelandProf. Dr. med. Berthold Langguth, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669069
- Sponsor's protocol ID
- Neuromoddevices
- Other IDs
- TENT-A1 (Stage A1)
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2016
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Arcy S, Hamilton C, Hughes S, Hall DA, Vanneste S, Langguth B, Conlon B. Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. BMJ Open. 2017 Oct 25;7(10):e018465. doi: 10.1136/bmjopen-2017-018465.
PubMed 29074518Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, Connor CO, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramaniam T, D'Arcy S, Lim HH. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci Transl Med. 2020 Oct 7;12(564):eabb2830. doi: 10.1126/scitranslmed.abb2830.
PubMed 33028707
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
- ClinicalTrials.gov ID
- NCT02669069
- Acronym / sponsor ID
- Neuromoddevices
- Conditions
- Tinnitus
- Keywords
- Bi-modal neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Neuromod Devices Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Regensburg
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 29 Jan 2016 (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.
This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
Detailed description
Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PS1 | Active comparator | Device: PS1 |
| PS2 | Active comparator | Device: PS2 |
| PS3 | Active comparator | Device: PS3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 70 years of age
- The ability to read and understand English/German
- Willing and able to provide informed consent
- Willing to commit to the full duration of the study
- Have been experiencing tinnitus 3 months to 5 years
Key exclusion criteria (21 listed)
- If participant has been diagnosed with objective tinnitus
- Commenced usage of hearing aid within the last 90 days
- Cases where pulsatility is the dominant feature of tinnitus
- Patients whose tinnitus cannot be masked during MML assessment
- Meniere's disease
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 |
|---|---|---|
| PS1Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones. | Device | PS1 |
| PS2Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones. | Device | PS2 |
| PS3Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones. | Device | PS3 |
Primary outcome
Tinnitus Functional Index
Time frame: Between baseline and 12 weeks
Tinnitus Handicap Inventory
Time frame: Between baseline and 12 weeks
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 20 Dec 2024.
- Background: PubMed 29074518D'Arcy S, Hamilton C, Hughes S, Hall DA, Vanneste S, Langguth B, Conlon B. Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. BMJ Open. 2017 Oct 25;7(10):e018465. doi: 10.1136/bmjopen-2017-018465.
- Results publication: PubMed 33028707Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, Connor CO, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramaniam T, D'Arcy S, Lim HH. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci Transl Med. 2020 Oct 7;12(564):eabb2830. doi: 10.1126/scitranslmed.abb2830.
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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.
Mr. Brendan Conlon principal investigator
St. James's Hospital, Ireland
Prof. Dr. med. Berthold Langguth principal investigator
University of Regensburg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS1, PS2 and PS3 in people with Tinnitus, run by Neuromod Devices Ltd. at 2 sites in 2 countries.
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 9 inclusion and 21 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: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Ireland. 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.
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?
Tinnitus Functional Index (time frame: Between baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669069, which also lists 2 linked publications.
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 20 Dec 2024.