TinnitusNCT04118907
Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
A study testing multiple sensory stimulation in people with Tinnitus and Acoustic Stimulation, run by Dan Su at 1 site in China.
Trial summary
In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Tinnitus, Acoustic Stimulation, Somatic Stimulation
- What is being tested?
- multiple sensory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2020to 30 Oct 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pure tone tinnitus
- Unilateral and bilateral
- female and male
- Tinnitus has a history of more than 6 months
Who cannot join
- Pulsatile tinnitus of blood vessel
- Meniere's disease
- Chronic headache
- Neurological diseases (such as brain tumors)
- Patients with mental / mental illness undergoing treatment
- Pregnant women and patients with other untreatable diseases
Trial locations and contacts
1 site in 1 country.
China1 site
E.N.T. department of the First Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official title: Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus
Read the detailed description
120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.
- Being tested
- multiple sensory stimulation
- Keywords
- tinnitus, stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple sensory stimulationDevice
The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.
| Study group | Role | What they receive |
|---|---|---|
| acoustic stimulation | Experimental | Pink noise in both ears is given to tinnitus patients. The pink noise is removed by notch filter from tinnitus frequencies that are 20 decibel higher than the threshold. Receives: Device: multiple sensory stimulation |
| somatic stimulation | Experimental | Three stimulation points were selected for each ear of tinnitus patients, namely ear door (CN.V), auditory Palace (CN.VII) and Yifeng (C2/3). The stimulation intensity should be needle-sensed. Receives: Device: multiple sensory stimulation |
| vestibular stimulation | Experimental | The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort. Receives: Device: multiple sensory stimulation |
| acoustic + somatic stimulation | Experimental | Combination of auditory and somatic stimulation for tinnitus patients Receives: Device: multiple sensory stimulation |
| acoustic + vestibular stimulation | Experimental | Combination of auditory and vestibular stimulation for tinnitus patients Receives: Device: multiple sensory stimulation |
| acoustic + somatic + vestibular stimulation | Experimental | Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients Receives: Device: multiple sensory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical audiometry and acoustic impedance
Assessment of hearing in patients
Measured: Three months from the time the patient was selected to the end of the stimulus
Tinnitus frequency and loudness
Detection of tinnitus frequency and loudness in patients
Measured: Three months from the time the patient was selected to the end of the stimulus
Tinnitus disability scale
Tinnitus handicap inventory score was used to detect the degree of tinnitus.0-16 points without disability, 18-36 points with mild disability, 38-56 points with moderate disability and 58-100 points with severe disability. The 95% confidence interval is 20 points, that is, the difference between the two tests before and after the experiment is greater than or equal to 20 points.
Measured: Three months from the time the patient was selected to the end of the stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study startJun 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completion30 Oct 2020 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Su, The First Affiliated Hospital of Anhui Medical University
- Investigators
- Busheng Tong, doctor, Study director, E.N.T. department of the First Affiliated hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118907
- Sponsor's protocol ID
- Mssftinnitus
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
- ClinicalTrials.gov ID
- NCT04118907
- Acronym / sponsor ID
- Mssftinnitus
- Keywords
- tinnitus, stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dan SuUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 8 Oct 2019 (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.
In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus
Detailed description
120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| acoustic stimulation | Experimental | Device: multiple sensory stimulationPink noise in both ears is given to tinnitus patients. The pink noise is removed by notch filter from tinnitus frequencies that are 20 decibel higher than the threshold. |
| somatic stimulation | Experimental | Device: multiple sensory stimulationThree stimulation points were selected for each ear of tinnitus patients, namely ear door (CN.V), auditory Palace (CN.VII) and Yifeng (C2/3). The stimulation intensity should be needle-sensed. |
| vestibular stimulation | Experimental | Device: multiple sensory stimulationThe patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort. |
| acoustic + somatic stimulation | Experimental | Device: multiple sensory stimulationCombination of auditory and somatic stimulation for tinnitus patients |
| acoustic + vestibular stimulation | Experimental | Device: multiple sensory stimulationCombination of auditory and vestibular stimulation for tinnitus patients |
| acoustic + somatic + vestibular stimulation | Experimental | Device: multiple sensory stimulationCombination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pure tone tinnitus
- Unilateral and bilateral
- female and male
- Tinnitus has a history of more than 6 months
Key exclusion criteria (6 listed)
- Pulsatile tinnitus of blood vessel
- Meniere's disease
- Chronic headache
- Neurological diseases (such as brain tumors)
- Patients with mental / mental illness undergoing treatment
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 |
|---|---|---|
| multiple sensory stimulationThe patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later. | Device | acoustic + somatic + vestibular stimulation, acoustic + somatic stimulation, acoustic + vestibular stimulation, acoustic stimulation, somatic stimulation, vestibular stimulation |
Primary outcome
Electrical audiometry and acoustic impedance
Time frame: Three months from the time the patient was selected to the end of the stimulus
Assessment of hearing in patients
Tinnitus frequency and loudness
Time frame: Three months from the time the patient was selected to the end of the stimulus
Detection of tinnitus frequency and loudness in patients
Tinnitus disability scale
Time frame: Three months from the time the patient was selected to the end of the stimulus
Tinnitus handicap inventory score was used to detect the degree of tinnitus.0-16 points without disability, 18-36 points with mild disability, 38-56 points with moderate disability and 58-100 points with severe disability. The 95% confidence interval is 20 points, that is, the difference between the two tests before and after the experiment is greater than or equal to 20 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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.
Busheng Tong, doctor study director
E.N.T. department of the First Affiliated hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiple sensory stimulation in people with Tinnitus and Acoustic Stimulation, run by Dan Su at 1 site in China.
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 4 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 5 Feb 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Su, master (+8615755149100, sudan19966991@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical audiometry and acoustic impedance (time frame: Three months from the time the patient was selected to the end of the stimulus). The study lists 3 primary outcomes in all. 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 5 Feb 2020.