TinnitusPhase 4CALMNCT00730834
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
A Phase 4 study testing Oasis in people with Tinnitus and Hyperacusis, run by Neuromonics, Inc. at 1 site in United States.
Trial summary
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Hyperacusis
- What is being tested?
- Oasis
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age,
- TRQ of at least 17 or above,
- Able to pay for the treatment,
- Not using any other treatment for tinnitus,
- Access to computer and internet,
- Compliant patient
Who cannot join
- Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
- Not willing to follow the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).
- Conditions
- Tinnitus, Hyperacusis
- Being tested
- Oasis
- Keywords
- tinnitus, ringing in the ears, buzzing, static, hyperacusis, loudness discomfort, Clinically, significant, discomfort
- Medical subject headings
- Tinnitus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OasisDevice
Also called Neuromonics Oasis Tinnitus Treatment
Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and post treatment scores on Tinnitus reaction questionnaire
Measured: 6, 12, 24, 36 months
Secondary outcomes (1)
Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,
Measured: 6, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730834
- Sponsor's protocol ID
- CALM Study
- Other IDs
- 20071022
- Acronym
- CALM
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis
- ClinicalTrials.gov ID
- NCT00730834
- Acronym / sponsor ID
- CALM / CALM Study
- Conditions
- Tinnitus, Hyperacusis
- Keywords
- tinnitus, ringing in the ears, buzzing, static, hyperacusis, loudness discomfort, Clinically, significant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Neuromonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 8 Aug 2008 (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.
Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age,
- TRQ of at least 17 or above,
- Able to pay for the treatment,
- Not using any other treatment for tinnitus,
- Access to computer and internet,
Key exclusion criteria (2 listed)
- Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
- Not willing to follow the protocol
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 |
|---|---|---|
| OasisAlso: Neuromonics Oasis Tinnitus TreatmentDigital sound player that provides customized acoustic stimulus based on subjects hearing thresholds | Device | – |
Primary outcome
Pre and post treatment scores on Tinnitus reaction questionnaire
Time frame: 6, 12, 24, 36 months
1 secondary outcome
Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,
Time frame: 6, 12, 24, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oasis in people with Tinnitus and Hyperacusis, run by Neuromonics, Inc. 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 2 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 25 Aug 2009. 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. 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?
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?
Pre and post treatment scores on Tinnitus reaction questionnaire (time frame: 6, 12, 24, 36 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 25 Aug 2009.