TinnitusNCT04787653
Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
A study testing Otoband in people with Tinnitus, run by Otolith Labs at 1 site in United States.
Trial summary
This proposed study is a blinded study in which the participant will wear the OtoBand when their tinnitus is present to determine if the OtoBand reduces the perceived loudness of their 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?
- Otoband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 28 Feb 2024
- 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
- Male or female subjects age 18 to 70 years old
- Tinnitus that has been present for at least 90 days
- Tinnitus that is constant or predictable
- Computer and access to internet for online video conference
- Score greater than or equal to 36 on the Tinnitus Handicap Questionnaire
- Access to a PayPal, Venmo account to receive compensation
Who cannot join
- Tinnitus that first presented within the last 90 days
- Tinnitus Handicap Questionnaire of 29 or less
- Skull base surgery within the last 90 days
- Any skull implant (cochlear implant, bone conduction implant, DBS)
- No history of vitreous detachment in the last 60 days (no new floaters or unexplained flashes of light in the eye)
- Taking benzodiazepines (e.g. clonazepam, lorazepam, diazepam) Participant reports that their tinnitus is caused by a medication they are taking
Trial locations and contacts
1 site in 1 country.
United States1 site
OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/
Washington D.C., District of Columbia, 20009
About this study
This proposed study is a blinded study in which the participant will wear the OtoBand when their tinnitus is present to determine if the OtoBand reduces the perceived loudness of their tinnitus. The Study will be placebo controlled with each participant using an effective device for half of the enrollment period and a placebo device for half of the enrollment period. The order of placebo and effective usage will be randomized, and the researchers will be blinded to which device a participant is using. Study participants will be instructed in an online telehealth conference on how to operate the OtoBand and how to wear the OtoBand. Participants will be enrolled for approximately 30 days from Informed Consent to Wrap-up call.
Read the detailed description
This study seeks to gather data on the effect of the OtoBand in participants who have reported symptoms of tinnitus. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the OtoBand and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic, there will be no in-person contact in the study.
Otolith Sound (hereafter: "Otolith") seeks to recruit study participants via several online channels including Facebook, Google and their website https://otolithlabs.com/tinnitustelehealthstudy/ . Otolith will use online advertisements to inform potential participants about the study and ask them to volunteer for online screening and enrollment.
Each participant will be enrolled in the study only after a successful video screening including agreement to participate. After a participant is enrolled, a device will be shipped to them via USPS or similar carrier. The participant will be instructed not to open the shipping box with the device until their initial study call with the study coordinator.
During the initial study call, participants will be instructed on how to use the OtoBand and how to wear the device. There will be a total of four online meetings with each study participant. It is expected that a typical participant will be enrolled in the study for approximately 30 days - from consent to filling out the last questionnaire and online wrap up meeting. In these 30 days, the participant will be wearing a device for 30 minutes each day over the course of two times 5 days. In addition to online study calls, Sponsor will use email and text messaging to communicate with the participants. For example, if a study participant does not complete a study diary on a given day, a text message will be sent reminding them to do so.
After the enrollment period, participants will be instructed to return the device in a pre-paid envelope. The devices will stop functioning 20 days after the first use.
- Conditions
- Tinnitus
- Being tested
- Otoband, Placebo
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtobandDevice
Participants with Tinnitus will wear the Otoband set at an effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form.
PlaceboDevice
Participants with Tinnitus will wear the Otoband set at a non-effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form.
| Study group | Role | What they receive |
|---|---|---|
| Otoband efficacy on Tinnitus | Active comparator | Participants will wear the Otoband on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Each participant will select his/her preferred stimulation level. The OtoBand will be programmed to operate at one of three power levels that are thought to be effective. The OtoBand will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form. Receives: Device: Otoband |
| Placebo device efficacy on Tinnitus | Placebo comparator | The placebo device will use the same case, headband and battery as the OtoBand. The transducer in the OtoBand will be rotated 90 degrees, so that the placebo device will vibrate in a direction ineffectual at providing bone conducted vibrations. The vibrations will be in the horizontal plane, parallel to the skull, and will not have their energy penetrating the skull all the way to the vestibular system. Each participant will select his/her preferred stimulation level. The placebo devices will be made to vibrate at one of three power levels, none of which are thought to be effective. The placebo will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
The primary endpoint will be the change in THQ score of a participant while wearing an effective device versus the THQ score at enrollment/baseline.
Measured: Forms filled out daily over two week period by the study participant
Secondary outcomes (2)
Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
Change in Quality of Life Measures at the conclusion of the study versus the start of enrollment as measured by the Tinnitus Handicap Questionnaire.
Measured: Forms filled out daily over two week period by the study participant
Identification of a preferred power level for tinnitus as determined by Otoband device log.
Identification of a preferred power level for tinnitus as determined by the power level that participants use for the longest cumulative use throughout the study.
Measured: Device use log over two week period of use by the study participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start5 Mar 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Depireux, PhD, Principal investigator, Otolith Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787653
- Sponsor's protocol ID
- OLith10801
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
- ClinicalTrials.gov ID
- NCT04787653
- Acronym / sponsor ID
- OLith10801
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 8 Mar 2021 (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.
This proposed study is a blinded study in which the participant will wear the OtoBand when their tinnitus is present to determine if the OtoBand reduces the perceived loudness of their tinnitus. The Study will be placebo controlled with each participant using an effective device for half of the enrollment period and a placebo device for half of the enrollment period. The order of placebo and effective usage will be randomized, and the researchers will be blinded to which device a participant is using. Study participants will be instructed in an online telehealth conference on how to operate the OtoBand and how to wear the OtoBand. Participants will be enrolled for approximately 30 days from Informed Consent to Wrap-up call.
Detailed description
This study seeks to gather data on the effect of the OtoBand in participants who have reported symptoms of tinnitus. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the OtoBand and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic, there will be no in-person contact in the study.
Otolith Sound (hereafter: "Otolith") seeks to recruit study participants via several online channels including Facebook, Google and their website https://otolithlabs.com/tinnitustelehealthstudy/ . Otolith will use online advertisements to inform potential participants about the study and ask them to volunteer for online screening and enrollment.
Each participant will be enrolled in the study only after a successful video screening including agreement to participate. After a participant is enrolled, a device will be shipped to them via USPS or similar carrier. The participant will be instructed not to open the shipping box with the device until their initial study call with the study coordinator.
During the initial study call, participants will be instructed on how to use the OtoBand and how to wear the device. There will be a total of four online meetings with each study participant. It is expected that a typical participant will be enrolled in the study for approximately 30 days - from consent to filling out the last questionnaire and online wrap up meeting. In these 30 days, the participant will be wearing a device for 30 minutes each day over the course of two times 5 days. In addition to online study calls, Sponsor will use email and text messaging to communicate with the participants. For example, if a study participant does not complete a study diary on a given day, a text message will be sent reminding them to do so.
After the enrollment period, participants will be instructed to return the device in a pre-paid envelope. The devices will stop functioning 20 days after the first use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otoband efficacy on Tinnitus | Active comparator | Device: OtobandParticipants will wear the Otoband on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Each participant will select his/her preferred stimulation level. The OtoBand will be programmed to operate at one of three power levels that are thought to be effective. The OtoBand will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form. |
| Placebo device efficacy on Tinnitus | Placebo comparator | Device: PlaceboThe placebo device will use the same case, headband and battery as the OtoBand. The transducer in the OtoBand will be rotated 90 degrees, so that the placebo device will vibrate in a direction ineffectual at providing bone conducted vibrations. The vibrations will be in the horizontal plane, parallel to the skull, and will not have their energy penetrating the skull all the way to the vestibular system. Each participant will select his/her preferred stimulation level. The placebo devices will be made to vibrate at one of three power levels, none of which are thought to be effective. The placebo will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects age 18 to 70 years old
- Tinnitus that has been present for at least 90 days
- Tinnitus that is constant or predictable
- Computer and access to internet for online video conference
- Score greater than or equal to 36 on the Tinnitus Handicap Questionnaire
Key exclusion criteria (6 listed)
- Tinnitus that first presented within the last 90 days
- Tinnitus Handicap Questionnaire of 29 or less
- Skull base surgery within the last 90 days
- Any skull implant (cochlear implant, bone conduction implant, DBS)
- No history of vitreous detachment in the last 60 days (no new floaters or unexplained flashes of light in the eye)
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 |
|---|---|---|
| OtobandParticipants with Tinnitus will wear the Otoband set at an effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form. | Device | Otoband efficacy on Tinnitus |
| PlaceboParticipants with Tinnitus will wear the Otoband set at a non-effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form. | Device | Placebo device efficacy on Tinnitus |
Primary outcome
Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
Time frame: Forms filled out daily over two week period by the study participant
The primary endpoint will be the change in THQ score of a participant while wearing an effective device versus the THQ score at enrollment/baseline.
2 secondary outcomes
Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
Time frame: Forms filled out daily over two week period by the study participant
Identification of a preferred power level for tinnitus as determined by Otoband device log.
Time frame: Device use log over two week period of use by the study participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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.
Didier Depireux, PhD principal investigator
Otolith Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otoband in people with Tinnitus, run by Otolith Labs at 1 site in United States.
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 6 inclusion and 6 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire (time frame: Forms filled out daily over two week period by the study participant). 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 22 Mar 2022.