A trial of a digital smartphone-based personalised tinnitus therapy.

This is a trial of a smartphone-based tinnitus therapy system that provides a 90-day program combining sound therapy and listening exercises. If participants meet the study criteria they will complete some questionnaires on an online form. Throughout the study which is 330 days long participants will be asked to repeat these questionnaires. After a period of waiting in which we measure participants' tinnitus several times for repeatability a new therapy will be trialed after EEG measures. The treatment is based on participants' treatment goals and an assessment of your tinnitus sound. The researcher will customize settings using a computer and download a software “app” to participants' phones. Participants will be provided with instructions on how to use the software and be provided open-ear earphones and a speaker to play sounds through. During 90 days of use we will ask participants to complete the tinnitus questionnaires several times. After 90 days of therapy is finished, we will ask them to complete the tinnitus questionnaires several times. When the trial is finish participants can keep the software and the earphones and speaker for free. DEVICE DESCRIPTION The QCore is a non-invasive solution for tinnitus sufferers, combining advanced technology with personalized care. The system consists of 1. Clinician dashboard, 2. Smart Phone software (iOS, Android), and 3. Bluetooth open-ear earphones. 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. A customised profile is established based on participant’s preferences and goals using a goal-assessment tool (Client Oriented Scale of Improvement in Tinnitus, COSIT). Five goals are placed in order of priority and an algorithm prescribes a 1-hour per day, 90-day 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 (TAN) profile 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 customize their therapy, and to monitor progress. The QCore software allocates participants time to three different therapy modes 1. Relief, 2. Relaxation, and 3. Retraining based on their COSIT priorities. If the COSIT priorities change (based on the participant’s selection on the software) weighting of time to the 3 modes is adjusted. The therapeutic components within each mode consist of 1. Counselling, 2. Passive Sound, and 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. Personalized sounds where the frequency response is tailored to the individuals minimum masking levels and perceived position in space are included. (ii) Relaxation sounds have positive emotion affect 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 target (non-tinnitus sounds). The training games are based on the Auditory Object Identification and Localization (AOIL) paradigm. 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 customized 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 aids 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-min period of active listening by the clinician, the participants 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 realize 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 be provided with instructions and take-home materials. Subsequent assessments will be undertaken remotely. Daily use will be logged to monitor adherence, recording time and module use. 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, 90-day 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. Repeated outcome measures will be obtained at nine time points for treatment groups: 1. Baseline 1 (Recruitment screening), 2. Baseline 2 (therapy provision 30 days following Baseline 1), 3. Treatment 1 following 30 days with therapy, 4. Treatment 2 following 60 days with therapy, 5. Treatment 3 following 90 days with therapy, 6. Post therapy 1 (30 days following therapy), 7. Post therapy 2 (60 days following therapy), 8. Post therapy 3 (90 days following therapy = 210 days following Baseline 1), 9. Trial end final post treatment measure (330 days following Baseline 1). Waitlist Control group schedule: Repeated outcome measures will be obtained at nine time points for the waitlist group: 1. Baseline 1 (Recruitment screening), 2. Baseline 2 (30 days following Baseline 1), 3. Baseline 3 (60 days following Baseline 2), 4. Treatment 1 (following 30 days with therapy), 5. Treatment 2 (following 60 days with therapy), 6. Treatment 3 (following 90 days with therapy), 7. Trial end final post treatment measure (330 days following Baseline 1). Baseline At baseline participants will be assigned a unique identifier code so data can be analysed in a deidentified manner. Participants will be provided with a link to online questionnaires coded, stored, and collated using the University's REDCap account. The system operates in accordance with safe design and software maintenance standards for medical software. At screening participants will complete: a comprehensive case history [Tinnitus Sample Case History Questionnaire, TSCHQ]. During baseline, and at each assessment point, participants will complete the TFI (a standard assessment questionnaire), and the Tinnitus Magnitude Index (a short measure aiding to quantify the tinnitus perception separate from reaction). The TFI will serve as the primary endpoint measure in this trial.