None listed
Conditions
Brief summary
This study aims to design a machine-learning model for digital therapeutics in tinnitus. The system can adjust sound treatment by biosensor data collected in real-time from patients and predict responders or non-responders at an early stage. The machine-learning model can differentiate patients’ tinnitus suffering conditions from non-suffering, and it can also predict responders and non-responders to sound therapy.
Interventions
Participants will be provided with a link to online questionnaires coded, stored, and collated using the University's database. All participants will need to complete a standard assessment questionnaire. Tinnitus psychoacoustic matching will be obtained, and consequent sound therapy will be prescribed for them by research clinicians. The control group will be provided with white noise only at the baseline. iMotion will be used to measure the multimodal biosensor data of participants, including
Participants will be provided with a link to online questionnaires coded, stored, and collated using the University's database. All participants will need to complete a standard assessment questionnaire. Tinnitus psychoacoustic matching will be obtained, and consequent sound therapy will be prescribed for them by research clinicians. The control group will be provided with white noise only at the baseline. iMotion will be used to measure the multimodal biosensor data of participants, including electroencephalogram (EEG), electrocardiogram ECG and galvanic skin response (GSR), during several phases. The whole assessment will be repeated after 6 weeks and 12 weeks of treatment. 20 participants will be recruited according to the inclusion and exclusion criteria. The same number of participants in the control group who matched the age and gender will be recruited later. DEVICE DESCRIPTION The QCore is a science-based, non-invasive solution for tinnitus sufferers, combining advanced technology with personalised care. The system consists of 1. Clinician dashboard 2. Smart Phone software (iOS, Android) 3. Hardware (i) Bluetooth open ear earphones (ii) Desktop speaker. 6.1 Clinician dashboard. The clinician dashboard allows each clinician to record client demographics, test tinnitus characteristics and transfer information to the client’s smartphone software. The dashboard enables viewing of real-time tinnitus client data and progress. An algorithm prescribes a 1-hour per day, 12-week treatment, weighted to individual needs from three different therapy modes: 1. Relief, 2. Relaxation 3. Retraining. Narrow-band noise minimum masking levels (MMLs) are measured. An algorithm is applied to the MMLs to create a custom Threshold Adjusted Noise profile (Searchfield et al., 2002) that can be applied to therapeutic sounds to improve masker efficacy. Participant Smartphone software. A unique code enables the client to download the necessary software to their ios or Android phone. The QCore software guides the client to customise their therapy and to monitor progress. The QCore software allocates participants' time to three different therapy modes 1. Relief 2. Relaxation 3. Retraining based on their COSIT priorities. If the COSIT priorities change (based on the participant’s selection of the software) weighting of time to the 3 modes is adjusted. The therapeutic component within each mode consists of 1. Counselling. 2. Passive Sound. 3. Active listening 1. Counselling: Automated periodic text-based counselling to improve self-management behaviours and achieve better therapy adherence. The text messages are brief explanatory messages relating to the task to be undertaken or motivational messages encouraging ongoing engagement in therapy. The messages appear intermittently alongside the therapy tasks. Recorded guided, abbreviated progressive relaxation, mindfulness, and deep breathing exercises are available as part of the relax mode. 2. Passive sound therapy: The tracks are selected from a library of sounds according to participant preference and goals. (i) Relief sounds have high interaction with tinnitus, creating masking. Personalised sounds where the frequency response is tailored to the individual's minimum masking levels and perceived position in space are included. (ii) Relaxation sounds have a positive emotional effect associated with calm situations (e.g., gentle waterfall). (iii) Retraining sounds are more complex nature sounds with multiple sound objects, and participants will be instructed to focus attention on these sounds, enabling retraining of attention away from tinnitus. 3. Active listening. This consists of a calibration task that gives the player agency over a sound resembling their tinnitus and games that present distractor sounds matching the location and frequency of tinnitus and target sounds remote from the tinnitus match. Participants are rewarded through points scored in responding to the target (non-tinnitus sounds). The training games are based on the AOIL paradigm (Searchfield et al., 2007). Hardware. The hardware consists of Cleer Arc II Bluetooth open-ear earphones. Intended Use QCore is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customised sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This includes hearing aid users. This is a medical device and should only be used with the advice of a physician, audiologist, or other hearing healthcare professional. Principles of Operation. Following a 20-minute period of active listening by the clinician, the participant's needs and goals with therapy will be ascertained using the Client Oriented Scale of Improvement in Tinnitus (COSIT) as part of the QCore therapy. The COSIT is a questionnaire, incorporated into the QCore system, in which the participant lists up to five improvement goals they hope to realise with the therapy, that they then rank. Pure tone audiometry will be conducted in a sound-treated room (ISO 8253–1:2010) and will employ the modified Hughson-Westlake procedure. Tinnitus psychoacoustic matching (tinnitus frequency, loudness per ear and location) will be obtained using the QCore therapy system. The participant will be prescribed the QCore therapy and provided with instructions and take-home materials. Subsequent assessments will be undertaken remotely. The system will be used by each participant at home according to the following protocol: Participants will be prescribed a minimum total of 1 hour per day, a 12-week treatment. The 1 hour of use can be distributed across a day. Participants will be guided by the software as to which tasks to undertake. Procedure: Baseline measurement: 1. At baseline, participants will be assigned a unique identifier code so data can be analysed in a de-identified manner. Participants will be provided with a link to online questionnaires coded, stored, and collated using the University's REDCap (Research Electronic Data Capture) account. 2. All participants will need to complete the Tinnitus Functional Index (TFI), a standard assessment questionnaire, and the Tinnitus Magnitude Index (TMI), a short measure aiding in quantifying the tinnitus perception. Depression Anxiety Stress Scales (DASS) will be obtained to assess the stress of participants from tinnitus suffering. 3. Tinnitus psychoacoustic matching will be obtained using the QCore therapy system: tinnitus frequency, loudness per ear and location. The participant will be prescribed the QCore therapy by the researcher clinician. 4. iMotion will be used to measure the multimodal biosensor data of participants, including electroencephalogram (EEG), electrocardiogram ECG and galvanic skin response (GSR). During the pre-treatment phase, resting-state multimodal biosensor data will be recorded for each subject with eyes open. After that, a course of sound therapy will be carried out for patients, for health controls, white noise will be substituted. Meanwhile, biosensor data will also be collected. Then, the iMotion system will continue to record multimodal biosensors for 10 minutes. A post-treatment phase. The post-treatment phase of patients will be demarcated by the disappearance of residual inhibition.
Sponsors
The university of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
To be eligible for this study, each of the following criteria must be satisfied with a “YES” answer (unless not applicable): 1. Participants aged 18 to 85 years, inclusive. 2. Participants can provide written informed consent. 3. The participant has chronic tinnitus (greater than 3 months) and is consistently aware of their tinnitus throughout much of the waking day. 4. A maximum of a moderate degree of hearing loss. 5. Hearing aid users will be eligible for the study but need to be able to hear therapy sounds through earphones unaided. 6. Participants will be smartphone users, be familiar with smartphone apps, and own active Android or Apple phones. 7. Individuals prescribed medications, including for anxiety or depression, will be eligible. 8. Participants will be asked to refrain from starting any new tinnitus treatments during the trial. 9. Participant has an overall score greater than or equal to 30 on the TFI at the Screening visit. 10. The participant is willing to comply with the protocol and attend all study visits and online assessments. Inclusion criteria for the control group 1. The control group do not have tinnitus or pulsatile tinnitus. 2. Participants do not have any physical pathologies involved in any system. 3. The hearing, age and gender of the control group will be matched with the tinnitus group.
Exclusion criteria
To be eligible for this study, each of the following criteria must be satisfied with a “NO” answer (unless not applicable): 1. Participant has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumour or stroke. 2. Participant has active middle ear disease, including but not limited to chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, cholesteatoma, Meniere’s disease, or retro-cochlear schwannoma. 3. Participant has recently (< 1 month of Screening) initiated new treatment for tinnitus (e.g. noise generators, hearing aids, behavioural therapy); only stable tinnitus treatments are allowed during the study. 4. Participant is not able to accurately identify and report their tinnitus. 5. Participant is receiving any ongoing therapy known as potentially tinnitus-inducing 6. The participant has severe or untreated depression or anxiety that, in the investigator’s opinion, would likely reduce the safety of study participation. 7. Participants have any other clinically significant illness, medical condition or medical history that, in the investigator’s opinion, would likely reduce the safety of study participation or prohibit the participant from participating in the study at Screening or at the time of randomization. Exclusion criteria for the control group: 1. The participant is receiving any ongoing therapy known as potentially tinnitus-inducing 2. The participant has severe or untreated depression or anxiety that, in the investigator’s opinion, would likely reduce the safety of study participation. 3. Participants have any other clinically significant illness, medical condition or medical history that, in the investigator’s opinion, would likely reduce the safety of study participation or prohibit the participant from participating in the study at Screening or at the time of randomisation.
Outcome results
None listed