TinnitusNCT06895824
Somatic Tracking for Tinnitus
A study testing Mindfulness Meditation in people with Tinnitus, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
We are examining the effect of mindfulness meditation on attitudes towards tinnitus, as well as physical and psychological distress associated with the condition. The meditation is designed to promote neuroplasticity, fostering new neural connections to help you reinterpret tinnitus through a lens of safety and reduce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Mindfulness Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing distressing tinnitus
- Sufficient English language and hearing ability to take part
- Completed all relevant medical and audiological investigations and concluded ensuing treatment for any underlying disease
- Not be engaging in any other therapy for tinnitus.
Who cannot join
- Risk to self (scoring 'nearly every day' on PHQ-9 question "Thoughts that you would be better off dead, or of hurting yourself in some way?")
- Severe mental health difficulties (PHQ-9 score of 20 or more)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shyn Wei Phua contact
United Kingdom1 site, 1 recruiting
- Recruiting
Online
London, NW1 9UT
Shyn Wei Phua, 07387634157, shyn.phua.21@ucl.ac.uk
About this study
Official title: Can Somatic Tracking Help People Living with Tinnitus?
We are examining the effect of mindfulness meditation on attitudes towards tinnitus, as well as physical and psychological distress associated with the condition. The meditation is designed to promote neuroplasticity, fostering new neural connections to help you reinterpret tinnitus through a lens of safety and reduce the perception of threat. This approach integrates several techniques from various psychological therapies which have been promising in reducing tinnitusrelated distress. Therefore, the purpose of this study is to see whether a guided mindfulness meditation intervention is effective in improving the acceptance of tinnitus symptoms, as well as reducing tinnitus-related distress in people living with tinnitus.
Read the detailed description
Somatic tracking is one aspect of most mindfulness meditation protocols, involving paying attention to the present non-judgementally, and focusing on breath and bodily sensations (e.g., sounds in the case tinnitus). By encouraging individuals to observe and reinterpret distressing symptoms as benign, it aims to decrease the brain's reactivity and vigilance towards tinnitus symptoms, promoting acceptance instead of maladaptive avoidance behaviours that can inadvertently heighten awareness of symptoms (McKenna et al., 2020). Reduced tinnitus-related fear has appeared to improve CBT treatment effects (Cima et al., 2018), while greater tinnitus acceptance is associated with reduced tinnitus distress and improved mental well-being (Westin et al., 2008). This coping strategy has also reduced distress in other conditions, such as traumatic brain injury (Garland et al., 2009). In line with the greater goals of mindfulness, somatic tracking encourages sustained and flexible attention to the wider experience and environment, moving away from narrowed attention to tinnitus symptoms. In redeploying attention beyond tinnitus, awareness extends to other stimuli, and tinnitus-related distress should reduce alongside decreased resistance and selective attention which contribute to the perception of tinnitus (Marks et al., 2020b). This study aims to explore the effectiveness of a somatic tracking intervention - Tinnitus Tracking, for tinnitus sufferers. This intervention constitutes a mindfulness activity commonly part of meditation/mindfulness programmes, which will be tested as a standalone intervention. We aim to answer: What is the effect of Tinnitus Tracking compared to no intervention on (1) participants' positive and negative thoughts towards their tinnitus and (2) the physical and psychological distress associated with the condition?
- Conditions
- Tinnitus
- Being tested
- Mindfulness Meditation
- Keywords
- tinnitus, mindfulness, mindfulness meditation, somatic tracking, tinnitus distress
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationOther
Also called Somatic Tracking
Somatic tracking is one aspect of most mindfulness meditation protocols, involving paying attention to the present non-judgementally, and focusing on breath and bodily sensations (e.g., sounds in the case tinnitus). This study employs this approach as a standalone intervention, in the form of a guided meditation recording.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group participants will be given the choice to proceed to the Tinnitus Tracking [TT] intervention, a 15-minute somatic tracking guided meditation recorded by Dr Florian Vogt, a tinnitus treatment specialist, immediately or the next day. Before starting the first session of the TT intervention, participants answer the question, 'Right now, how annoying is your tinnitus?" using ratings on a scale from 1 (not at all) to 10 (much more). Each session of the TT intervention involves the guided meditation session, followed by the tinnitus annoyance rating. Participants will be reminded to complete one session daily over a period of two weeks and will only be allowed to access the experiment once a day. Reminders will be sent daily via email by Gorilla, once access to the intervention for the day has been provided. Receives: Other: Mindfulness Meditation |
| Control | No intervention | Participants in this arm do not have tasks to complete over the two-week study period. A wait-list control condition will be set-up for this group, whereby participants will receive the intervention after completing the follow-up measures in two weeks. Since our sample is non-clinical and less at risk, we believe the two week delay period should not cause distress or adverse events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitions about Tinnitus
Positive and negative thoughts about tinnitus will be assessed with the Tinnitus Cognitions Questionnaire (TCQ) (Wilson \& Henry 1998). It consists of 26 items (statements) rated on a 5-point Likert scale. For example, "if only the noise would go away." The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. The TCQ has been supported as a valid measure of positive and negative thinking in tinnitus (Handscomb et al., 2017), demonstrates good reliability, and is suitable for research use
Measured: Baseline and 2 weeks
Psychological Distress
Depression will be assessed on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 1999), with nine items, such as "Feeling down, depressed, or hopeless?". Anxiety will be assessed on the Generalised Anxiety Disorder Assessment-7 (GAD-7) (Spitzer et al., 2006), with seven items, for example "Feeling afraid as if something awful might happen". Both the PHQ-9 and GAD-7 have been shown to be valid and reliable in assessing depressive and anxious symptoms respectively.
Measured: Baseline and 2 weeks
Tinnitus Severity
Tinnitus severity will be assessed using the Tinnitus Functional Index (TFI) (Meikle et al., 2012). It consists of 25 items covering overall tinnitus severity and negative impact. The TFI has demonstrated sensitivity to treatment-related change, high validity, and good reliability. The measure has been concluded to be suitable for both clinical and research purposes.
Measured: Baseline and 2 weeks
Tinnitus Annoyance Rating
Participants answer the question, 'Right now, how annoying is your tinnitus?" using ratings on a scale from 1 (not at all) to 10 (much more). Each session of the TT intervention involves the guided meditation session, followed by the tinnitus annoyance rating.
Measured: Baseline and daily over 2 weeks
Secondary outcomes (1)
Post-Study Feedback
Data from the post-study feedback survey, regarding satisfaction with and acceptability of the intervention and study.
Measured: At the end of the study (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start11 Dec 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Florian Vogt, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895824
- Sponsor's protocol ID
- 21415/001
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research, all research documents (e.g. questionnaires, responses) will be securely stored on UCL's Research Data Storage System (RDSS). After data analysis and sharing of results with interested participants all identifiable data (i.e., email address) will be deleted.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Somatic Tracking Help People Living with Tinnitus?
- ClinicalTrials.gov ID
- NCT06895824
- Acronym / sponsor ID
- 21415/001
- Conditions
- Tinnitus
- Keywords
- tinnitus, mindfulness, mindfulness meditation, somatic tracking, tinnitus distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
We are examining the effect of mindfulness meditation on attitudes towards tinnitus, as well as physical and psychological distress associated with the condition. The meditation is designed to promote neuroplasticity, fostering new neural connections to help you reinterpret tinnitus through a lens of safety and reduce the perception of threat. This approach integrates several techniques from various psychological therapies which have been promising in reducing tinnitusrelated distress. Therefore, the purpose of this study is to see whether a guided mindfulness meditation intervention is effective in improving the acceptance of tinnitus symptoms, as well as reducing tinnitus-related distress in people living with tinnitus.
Detailed description
Somatic tracking is one aspect of most mindfulness meditation protocols, involving paying attention to the present non-judgementally, and focusing on breath and bodily sensations (e.g., sounds in the case tinnitus). By encouraging individuals to observe and reinterpret distressing symptoms as benign, it aims to decrease the brain's reactivity and vigilance towards tinnitus symptoms, promoting acceptance instead of maladaptive avoidance behaviours that can inadvertently heighten awareness of symptoms (McKenna et al., 2020). Reduced tinnitus-related fear has appeared to improve CBT treatment effects (Cima et al., 2018), while greater tinnitus acceptance is associated with reduced tinnitus distress and improved mental well-being (Westin et al., 2008). This coping strategy has also reduced distress in other conditions, such as traumatic brain injury (Garland et al., 2009). In line with the greater goals of mindfulness, somatic tracking encourages sustained and flexible attention to the wider experience and environment, moving away from narrowed attention to tinnitus symptoms. In redeploying attention beyond tinnitus, awareness extends to other stimuli, and tinnitus-related distress should reduce alongside decreased resistance and selective attention which contribute to the perception of tinnitus (Marks et al., 2020b). This study aims to explore the effectiveness of a somatic tracking intervention - Tinnitus Tracking, for tinnitus sufferers. This intervention constitutes a mindfulness activity commonly part of meditation/mindfulness programmes, which will be tested as a standalone intervention. We aim to answer: What is the effect of Tinnitus Tracking compared to no intervention on (1) participants' positive and negative thoughts towards their tinnitus and (2) the physical and psychological distress associated with the condition?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Mindfulness MeditationIntervention group participants will be given the choice to proceed to the Tinnitus Tracking [TT] intervention, a 15-minute somatic tracking guided meditation recorded by Dr Florian Vogt, a tinnitus treatment specialist, immediately or the next day. Before starting the first session of the TT intervention, participants answer the question, 'Right now, how annoying is your tinnitus?" using ratings on a scale from 1 (not at all) to 10 (much more). Each session of the TT intervention involves the guided meditation session, followed by the tinnitus annoyance rating. Participants will be reminded to complete one session daily over a period of two weeks and will only be allowed to access the experiment once a day. Reminders will be sent daily via email by Gorilla, once access to the intervention for the day has been provided. |
| Control | No intervention | –Participants in this arm do not have tasks to complete over the two-week study period. A wait-list control condition will be set-up for this group, whereby participants will receive the intervention after completing the follow-up measures in two weeks. Since our sample is non-clinical and less at risk, we believe the two week delay period should not cause distress or adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experiencing distressing tinnitus
- Sufficient English language and hearing ability to take part
- Completed all relevant medical and audiological investigations and concluded ensuing treatment for any underlying disease
- Not be engaging in any other therapy for tinnitus.
Key exclusion criteria (2 listed)
- Risk to self (scoring 'nearly every day' on PHQ-9 question "Thoughts that you would be better off dead, or of hurting yourself in some way?")
- Severe mental health difficulties (PHQ-9 score of 20 or more)
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 |
|---|---|---|
| Mindfulness MeditationAlso: Somatic TrackingSomatic tracking is one aspect of most mindfulness meditation protocols, involving paying attention to the present non-judgementally, and focusing on breath and bodily sensations (e.g., sounds in the case tinnitus). This study employs this approach as a standalone intervention, in the form of a guided meditation recording. | Other | Intervention |
Primary outcome
Cognitions about Tinnitus
Time frame: Baseline and 2 weeks
Positive and negative thoughts about tinnitus will be assessed with the Tinnitus Cognitions Questionnaire (TCQ) (Wilson \& Henry 1998). It consists of 26 items (statements) rated on a 5-point Likert scale. For example, "if only the noise would go away." The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. The TCQ has been supported as a valid measure of positive and negative thinking in tinnitus (Handscomb et al., 2017), demonstrates good reliability, and is suitable for research use
Psychological Distress
Time frame: Baseline and 2 weeks
Depression will be assessed on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 1999), with nine items, such as "Feeling down, depressed, or hopeless?". Anxiety will be assessed on the Generalised Anxiety Disorder Assessment-7 (GAD-7) (Spitzer et al., 2006), with seven items, for example "Feeling afraid as if something awful might happen". Both the PHQ-9 and GAD-7 have been shown to be valid and reliable in assessing depressive and anxious symptoms respectively.
Tinnitus Severity
Time frame: Baseline and 2 weeks
Tinnitus severity will be assessed using the Tinnitus Functional Index (TFI) (Meikle et al., 2012). It consists of 25 items covering overall tinnitus severity and negative impact. The TFI has demonstrated sensitivity to treatment-related change, high validity, and good reliability. The measure has been concluded to be suitable for both clinical and research purposes.
Tinnitus Annoyance Rating
Time frame: Baseline and daily over 2 weeks
Participants answer the question, 'Right now, how annoying is your tinnitus?" using ratings on a scale from 1 (not at all) to 10 (much more). Each session of the TT intervention involves the guided meditation session, followed by the tinnitus annoyance rating.
1 secondary outcome
Post-Study Feedback
Time frame: At the end of the study (2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes. After the research, all research documents (e.g. questionnaires, responses) will be securely stored on UCL's Research Data Storage System (RDSS). After data analysis and sharing of results with interested participants all identifiable data (i.e., email address) will be deleted.
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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.
Shyn Wei Phua contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Tinnitus, run by University College London Hospitals at 1 site in United Kingdom.
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 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Vogt (00442034565651, florian.vogt@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitions about Tinnitus (time frame: Baseline and 2 weeks). The study lists 4 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 26 Mar 2025.