TinnitusNCT03022084
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
A study testing Desyncra and Cognitive Behavioral Therapy in people with Tinnitus, run by VA National Center for Rehabilitative Auditory Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Desyncra and Cognitive Behavioral Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- Primary and persistent tinnitus (6 months or longer in duration)
- Tonal tinnitus
- Dominant tinnitus frequency measured between 0.2 and 10 kHz
- Tinnitus Questionnaire score
- No current participation in other tinnitus therapy program
- Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial
- Able to pass the Tone Audibility Assessment with factor of 1.1
Who cannot join
- Secondary/somatic tinnitus due to a suspected underlying disease
- Atonal, pulsatile, intermittent, or occasional tinnitus
- Any hearing threshold >70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1
- Any health or other problems that may prevent the person from completing the study procedures as determined by investigator
- Participant reports current suicidal ideation and/or homicidal ideation
- Use of medication which may trigger tinnitus [e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin]
Show all 12Show fewer
- Conductive hearing loss
- Visible congenital or traumatic deformity of the ear
- History of active drainage from the ear within the past 90 days
- History of sudden or rapidly progressive hearing loss within the past 90 days
- Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures
- Previous use of Desyncra for Tinnitus Therapy System
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, National Center for Rehabilitative Auditory Research
Portland, Oregon, 97239
About this study
The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.
Read the detailed description
This study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of the two groups. Depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.
- Conditions
- Tinnitus
- Being tested
- Desyncra, Cognitive Behavioral Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesyncraDevice
Also called Desyncra™ for Tinnitus Therapy System
This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
Cognitive Behavioral TherapyOther
Also called CBT
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Desyncra | Experimental | This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System. Receives: Device: Desyncra |
| Cognitive Behavioral Therapy | Other | Standard of Care Receives: Other: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Questionnaire (TQ)
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
Measured: 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA National Center for Rehabilitative Auditory Research
- Sponsor type
- US federal agency
- Collaborators
- Desyncra, Inc.
- Responsible party
- Principal investigator, Sarah Theodoroff, VA National Center for Rehabilitative Auditory Research
- Investigators
- James Henry (PI), PhD, Principal investigator, VA RR&D NCRARSarah Theodoroff (Co-PI), PhD, Principal investigator, VA RR&D NCRAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022084
- Sponsor's protocol ID
- PVARF-387005
- Status last verified
- Jun 2020
- First submitted
- 12 Jan 2017
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
- ClinicalTrials.gov ID
- NCT03022084
- Acronym / sponsor ID
- PVARF-387005
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- VA National Center for Rehabilitative Auditory ResearchUS federal agency
- Collaborators
- Desyncra, Inc.
- Study start
- Jan 2017
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.
Detailed description
This study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of the two groups. Depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desyncra | Experimental | Device: DesyncraThis group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System. |
| Cognitive Behavioral Therapy | Other | Other: Cognitive Behavioral TherapyStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Primary and persistent tinnitus (6 months or longer in duration)
- Tonal tinnitus
- Dominant tinnitus frequency measured between 0.2 and 10 kHz
- Tinnitus Questionnaire score
Key exclusion criteria (12 listed)
- Secondary/somatic tinnitus due to a suspected underlying disease
- Atonal, pulsatile, intermittent, or occasional tinnitus
- Any hearing threshold >70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1
- Any health or other problems that may prevent the person from completing the study procedures as determined by investigator
- Participant reports current suicidal ideation and/or homicidal ideation
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 |
|---|---|---|
| DesyncraAlso: Desyncra™ for Tinnitus Therapy SystemThis group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System. | Device | Desyncra |
| Cognitive Behavioral TherapyAlso: CBTStandard of Care | Other | Cognitive Behavioral Therapy |
Primary outcome
Tinnitus Questionnaire (TQ)
Time frame: 24-weeks
52-item questionnaire that measures the functional impact of tinnitus (scores range from 0 to 104); lower scores indicate better outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
James Henry (PI), PhD principal investigator
VA RR&D NCRAR
Sarah Theodoroff (Co-PI), PhD principal investigator
VA RR&D NCRAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desyncra and Cognitive Behavioral Therapy in people with Tinnitus, run by VA National Center for Rehabilitative Auditory Research 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 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: finished, as of the sponsor's last update on 13 Jul 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Questionnaire (TQ) (time frame: 24-weeks). 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 13 Jul 2020.