TinnitusNCT07637708
Personalized Music-Embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity
A study testing Music intervention in people with Tinnitus, run by University of Chile at 1 site in Chile.
Trial summary
This clinical trial evaluated a personalized music-embedded sound therapy for adults with chronic subjective tinnitus. Tinnitus is the perception of sound, such as ringing or buzzing, without an external source and can negatively affect quality of life. Participants were randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2024to 10 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years.
- Diagnosis of chronic subjective tinnitus lasting more than 6 months.
- Non-pulsatile tinnitus.
- Tonal tinnitus with an identifiable tinnitus frequency.
- Unilateral or bilateral tinnitus.
- Ability to understand the study procedures and provide written informed consent.
- Ability to comply with the assigned sound therapy protocol and follow-up assessments.
Who cannot join
- Pulsatile tinnitus.
- Non-tonal tinnitus.
- History of auditory hallucinations.
- History of Ménière's disease.
- History of other active middle or inner ear disease with neurological sequelae.
- Current use of centrally acting medications that could interfere with tinnitus perception or auditory processing.
- Severe hearing loss preventing adequate perception of the auditory stimuli.
- Inability to complete the follow-up assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Music-embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity in Adults Between 18 and 75 Years, With Chronic Tinnitus, Assessed With Tinnitus Handicap Inventory (THI)
This clinical trial evaluated a personalized music-embedded sound therapy for adults with chronic subjective tinnitus. Tinnitus is the perception of sound, such as ringing or buzzing, without an external source and can negatively affect quality of life.
Participants were randomly assigned to one of two groups. One group received personalized music-embedded desynchronization sound therapy, using tones selected according to each participant's tinnitus frequency and embedded in music. The comparison group received low-frequency sound stimulation embedded in music. Both interventions were designed to be similar for participants.
The main objective was to evaluate whether the personalized music-embedded sound therapy reduced tinnitus severity compared with low-frequency sound stimulation. Tinnitus severity was measured using the Tinnitus Handicap Inventory at baseline and during follow-up.
Read the detailed description
Arm 1 - Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)
Brief name: Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)
Description of the intervention: Participants allocated to this arm will receive a sound-based neuromodulation therapy consisting of acoustic stimulation sequences embedded within musical tracks. The intervention is designed to deliver patterned auditory stimuli based on the principles of coordinated reset neuromodulation, which aims to reduce abnormal neural synchrony associated with chronic tinnitus. The intervention consists of pre-processed audio files containing therapeutic acoustic stimulation integrated into music tracks. These audio files are delivered through personal listening devices (e.g., smartphone or portable audio player) using standard headphones. Participants will be instructed to listen to the therapeutic audio tracks daily in a quiet environment. The intervention will be self-administered by participants at home.
Delivery procedures: Participants will receive instructions from a physician or trained researcher with experience in tinnitus management. During the baseline visit, participants will be instructed on the correct use of the audio files and listening protocol. Participants will be instructed to listen to the therapeutic audio program for approximately 1 hour per day, preferably during periods of relaxation or low environmental noise.
Duration of intervention: The intervention will be performed daily for 3 months.
Mode of delivery: Individual, self-administered listening sessions. Delivered through personal audio devices and headphones. Conducted primarily in the participant's home environment
Materials used in the intervention: Pre-generated therapeutic audio tracks containing embedded acoustic stimulation sequences. The use standard headphones or earphones with personal audio playback device (smartphone or portable audio player)
Intervention providers: The intervention protocol will be prescribed and explained by a physician specializing in otolaryngology and tinnitus management. Participants will perform the listening sessions independently.
Personalisation or adaptation: The stimulation frequencies embedded in the audio tracks are individualized according to the participant's tinnitus pitch characteristics when available, in order to optimize the neuromodulation effect.
Adherence monitoring: Participants will be asked to report their listening time during follow-up visits at 1 month, 2 months, and 3 months. Compliance will be assessed through participant self-report.
Arm 2 - Low Frequency Stimulation (LFS) Brief name: Low Frequency Stimulation (LFS)
Description of the intervention: Participants in this arm will receive acoustic stimulation consisting of low-frequency tonal sound stimulation delivered through audio tracks. The stimulation is designed as a comparator sound-based intervention for tinnitus. Participants will receive audio files containing low-frequency acoustic stimuli delivered through personal listening devices using standard headphones.
Delivery procedures: Participants will be instructed by the study investigators on how to perform the listening sessions. The stimulation will be self-administered by participants in their home environment.
Duration and schedule: Participants will listen to the stimulation program for approximately 1 hour per day over a 3-month period.
Mode of delivery: Individual listening sessions, delivered through headphones and personal audio playback devices. Conducted primarily in the participant's home environment
Materials used: Pre-generated audio files containing low-frequency stimulation, with standard headphones or earphones and personal audio playback device
Intervention providers: The protocol will be explained by a physician or trained researcher experienced in tinnitus treatment.
Adherence monitoring: Compliance will be evaluated through participant self-report during follow-up visits at 1, 2, and 3 months.
- Conditions
- Tinnitus
- Being tested
- Music intervention
- Keywords
- tinnitus, Music therapy, Desynchronization, Auditory neuromodulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Auditory tones music-embedded
| Study group | Role | What they receive |
|---|---|---|
| Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST) | Experimental | Participants allocated to this arm will receive a sound-based neuromodulation therapy consisting of acoustic stimulation sequences embedded within musical tracks. The intervention is designed to deliver patterned auditory stimuli based on the principles of coordinated reset neuromodulation, which aims to reduce abnormal neural synchrony associated with chronic tinnitus. The intervention consists of pre-processed audio files containing therapeutic acoustic stimulation integrated into music tracks. These audio files are delivered through personal listening devices (e.g., smartphone or portable audio player) using standard headphones. Participants will be instructed to listen to the therapeutic audio tracks daily in a quiet environment. The intervention will be self-administered by participants at home. Receives: Other: Music intervention |
| Low Frequency Stimulation (LFS) | Active comparator | Participants in this arm will receive acoustic stimulation consisting of low-frequency tonal sound stimulation delivered through audio tracks. The stimulation is designed as a comparator sound-based intervention for tinnitus. Participants will receive audio files containing low-frequency acoustic stimuli delivered through personal listening devices using standard headphones. Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus severity
Tinnitus handicap inventory
Measured: baseline, 1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Oct 2024
- Primary completion1 Nov 2025
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Henriquez, University of Chile
- Investigators
- Paul Delano, PhD, Study director, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637708
- Sponsor's protocol ID
- 0787
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of privacy and confidentiality considerations related to the small sample size. Aggregate results may be reported in scientific publications.
Publications
Eggermont JJ, Tass PA. Maladaptive neural synchrony in tinnitus: origin and restoration. Front Neurol. 2015 Feb 17;6:29. doi: 10.3389/fneur.2015.00029. eCollection 2015.
PubMed 25741316Adamchic I, Toth T, Hauptmann C, Walger M, Langguth B, Klingmann I, Tass PA. Acute effects and after-effects of acoustic coordinated reset neuromodulation in patients with chronic subjective tinnitus. Neuroimage Clin. 2017 May 28;15:541-558. doi: 10.1016/j.nicl.2017.05.017. eCollection 2017.
PubMed 28652968Adamchic I, Hauptmann C, Tass PA. Changes of oscillatory activity in pitch processing network and related tinnitus relief induced by acoustic CR neuromodulation. Front Syst Neurosci. 2012 Apr 5;6:18. doi: 10.3389/fnsys.2012.00018. eCollection 2012.
PubMed 22493570
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Music-embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity in Adults Between 18 and 75 Years, With Chronic Tinnitus, Assessed With Tinnitus Handicap Inventory (THI)
- ClinicalTrials.gov ID
- NCT07637708
- Acronym / sponsor ID
- 0787
- Conditions
- Tinnitus
- Keywords
- tinnitus, Music therapy, Desynchronization, Auditory neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 10 Jun 2026 (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 clinical trial evaluated a personalized music-embedded sound therapy for adults with chronic subjective tinnitus. Tinnitus is the perception of sound, such as ringing or buzzing, without an external source and can negatively affect quality of life.
Participants were randomly assigned to one of two groups. One group received personalized music-embedded desynchronization sound therapy, using tones selected according to each participant's tinnitus frequency and embedded in music. The comparison group received low-frequency sound stimulation embedded in music. Both interventions were designed to be similar for participants.
The main objective was to evaluate whether the personalized music-embedded sound therapy reduced tinnitus severity compared with low-frequency sound stimulation. Tinnitus severity was measured using the Tinnitus Handicap Inventory at baseline and during follow-up.
Detailed description
Arm 1 - Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)
Brief name: Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST)
Description of the intervention: Participants allocated to this arm will receive a sound-based neuromodulation therapy consisting of acoustic stimulation sequences embedded within musical tracks. The intervention is designed to deliver patterned auditory stimuli based on the principles of coordinated reset neuromodulation, which aims to reduce abnormal neural synchrony associated with chronic tinnitus. The intervention consists of pre-processed audio files containing therapeutic acoustic stimulation integrated into music tracks. These audio files are delivered through personal listening devices (e.g., smartphone or portable audio player) using standard headphones. Participants will be instructed to listen to the therapeutic audio tracks daily in a quiet environment. The intervention will be self-administered by participants at home.
Delivery procedures: Participants will receive instructions from a physician or trained researcher with experience in tinnitus management. During the baseline visit, participants will be instructed on the correct use of the audio files and listening protocol. Participants will be instructed to listen to the therapeutic audio program for approximately 1 hour per day, preferably during periods of relaxation or low environmental noise.
Duration of intervention: The intervention will be performed daily for 3 months.
Mode of delivery: Individual, self-administered listening sessions. Delivered through personal audio devices and headphones. Conducted primarily in the participant's home environment
Materials used in the intervention: Pre-generated therapeutic audio tracks containing embedded acoustic stimulation sequences. The use standard headphones or earphones with personal audio playback device (smartphone or portable audio player)
Intervention providers: The intervention protocol will be prescribed and explained by a physician specializing in otolaryngology and tinnitus management. Participants will perform the listening sessions independently.
Personalisation or adaptation: The stimulation frequencies embedded in the audio tracks are individualized according to the participant's tinnitus pitch characteristics when available, in order to optimize the neuromodulation effect.
Adherence monitoring: Participants will be asked to report their listening time during follow-up visits at 1 month, 2 months, and 3 months. Compliance will be assessed through participant self-report.
Arm 2 - Low Frequency Stimulation (LFS) Brief name: Low Frequency Stimulation (LFS)
Description of the intervention: Participants in this arm will receive acoustic stimulation consisting of low-frequency tonal sound stimulation delivered through audio tracks. The stimulation is designed as a comparator sound-based intervention for tinnitus. Participants will receive audio files containing low-frequency acoustic stimuli delivered through personal listening devices using standard headphones.
Delivery procedures: Participants will be instructed by the study investigators on how to perform the listening sessions. The stimulation will be self-administered by participants in their home environment.
Duration and schedule: Participants will listen to the stimulation program for approximately 1 hour per day over a 3-month period.
Mode of delivery: Individual listening sessions, delivered through headphones and personal audio playback devices. Conducted primarily in the participant's home environment
Materials used: Pre-generated audio files containing low-frequency stimulation, with standard headphones or earphones and personal audio playback device
Intervention providers: The protocol will be explained by a physician or trained researcher experienced in tinnitus treatment.
Adherence monitoring: Compliance will be evaluated through participant self-report during follow-up visits at 1, 2, and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST) | Experimental | Other: Music interventionParticipants allocated to this arm will receive a sound-based neuromodulation therapy consisting of acoustic stimulation sequences embedded within musical tracks. The intervention is designed to deliver patterned auditory stimuli based on the principles of coordinated reset neuromodulation, which aims to reduce abnormal neural synchrony associated with chronic tinnitus. The intervention consists of pre-processed audio files containing therapeutic acoustic stimulation integrated into music tracks. These audio files are delivered through personal listening devices (e.g., smartphone or portable audio player) using standard headphones. Participants will be instructed to listen to the therapeutic audio tracks daily in a quiet environment. The intervention will be self-administered by participants at home. |
| Low Frequency Stimulation (LFS) | Active comparator | Other: Music interventionParticipants in this arm will receive acoustic stimulation consisting of low-frequency tonal sound stimulation delivered through audio tracks. The stimulation is designed as a comparator sound-based intervention for tinnitus. Participants will receive audio files containing low-frequency acoustic stimuli delivered through personal listening devices using standard headphones. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 75 years.
- Diagnosis of chronic subjective tinnitus lasting more than 6 months.
- Non-pulsatile tinnitus.
- Tonal tinnitus with an identifiable tinnitus frequency.
- Unilateral or bilateral tinnitus.
Key exclusion criteria (8 listed)
- Pulsatile tinnitus.
- Non-tonal tinnitus.
- History of auditory hallucinations.
- History of Ménière's disease.
- History of other active middle or inner ear disease with neurological sequelae.
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 |
|---|---|---|
| Music interventionAuditory tones music-embedded | Other | Low Frequency Stimulation (LFS), Music-Integrated Modified Integrated Desynchronization Therapy (mMIDST) |
Primary outcome
Tinnitus severity
Time frame: baseline, 1 month, 2 months, 3 months
Tinnitus handicap inventory
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 10 Jun 2026.
- Background: PubMed 25741316Eggermont JJ, Tass PA. Maladaptive neural synchrony in tinnitus: origin and restoration. Front Neurol. 2015 Feb 17;6:29. doi: 10.3389/fneur.2015.00029. eCollection 2015.
- Background: PubMed 28652968Adamchic I, Toth T, Hauptmann C, Walger M, Langguth B, Klingmann I, Tass PA. Acute effects and after-effects of acoustic coordinated reset neuromodulation in patients with chronic subjective tinnitus. Neuroimage Clin. 2017 May 28;15:541-558. doi: 10.1016/j.nicl.2017.05.017. eCollection 2017.
- Background: PubMed 22493570Adamchic I, Hauptmann C, Tass PA. Changes of oscillatory activity in pitch processing network and related tinnitus relief induced by acoustic CR neuromodulation. Front Syst Neurosci. 2012 Apr 5;6:18. doi: 10.3389/fnsys.2012.00018. eCollection 2012.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of privacy and confidentiality considerations related to the small sample size. Aggregate results may be reported in scientific publications.
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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.
Paul Delano, PhD study director
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Tinnitus, run by University of Chile at 1 site in Chile.
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 7 inclusion and 8 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 10 Jun 2026. 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 Chile. 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 severity (time frame: baseline, 1 month, 2 months, 3 months). 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 NCT07637708, which also lists 3 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 10 Jun 2026.