UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The study includes a 12-week treatment trial for chronic tinnitus patients using 4 different
      types of interventions (hearing aids, sound therapy, structured counseling, cognitive
      behavioral therapy) either as a single treatment or a combination of two treatments. There
      are several aims of the study: compare 1) single vs. combined treatments, 2) single
      treatments vs. other treatments, 3) ear and brain based interventions, 4) analyzing data of
      the clinical trial in combination with other recorded data (genetic and proteomic data,
      audiology data) to develop in silico models of tinnitus and a decision support system with
      the aim to aid in treatment decisions. This randomized controlled trial is harmonized over
      five clinical centers in Europe with the aim to include 100 patients per center and is part
      of the UNITI-project (UNification of treatments and Interventions for TInnitus patients)
      funded by the European Union's Horizon 2020 programme (grant agreement number 848261).
    

Detailed description: 
      The study will be conducted as a randomized controlled trial (RCT), which investigates the
      effect of four different tinnitus therapy approaches applied over a time period of 12 weeks
      as a single or rather a combinatory treatment in 100 chronic tinnitus patients. The protocol
      of the RCT is harmonized over five clinical centers across Europe with each center
      responsible for study procedures (regulations with respect to CGP, GDPR etc.) themselves.
      Thus, the present protocol is for the Regensburg part of the study. Used therapies are -
      hearing aid (HA), sound therapy (ST), structured counseling (SC) and cognitive behavioral
      therapy for tinnitus (CBT4T). HA fitting will be conducted with CE-marked hearing aids from
      Signia Hearing Aids (Sivantos Pte. Ltd., Singapore, Republic of Singapore/ WSAudiology,
      Lynge, Denmark) with respect to patients hearing profile according to a standardized
      procedure. ST will be performed via a specifically developed mobile application (according to
      the European regulations for medical software (IEC 62304, IEC 82304)). Patients can select
      among 64 standardized or individualized (according to their tinnitus characteristics) sounds
      presented at a maximum loudness of 85 dB. A standardized SC protocol will be provided via a
      mobile application (preferably), URL-links, e-mail or in printed form over a 12-week
      treatment period including 12 chapters (one per week). CBT4T will be held on a weekly basis
      in groups not bigger than 6 patients á 1.5-2 hours. All interventions will be carried out by
      staff with corresponding expertise (e.g., audiologist or psychologists) or specially trained
      study assistants by these experts.

      Prior to the start of the study, potential participants will be online pre-screened with
      respect to inclusion and exclusion criteria. If the potential candidates are appropriate for
      a participation, they will be invited for a first visit on-site for a detailed screening of
      inclusion and exclusion criteria, and of health-related, tinnitus-specific, audiological
      examinations and electrophysiological measurements (auditory brainstem response, auditory
      middle latency response). Based on their determined hearing profile the decision will be
      made, whether there is an indication for the application of a HA. Accordingly, the sample of
      patients will be stratified into two groups: patients with an HA indication and those without
      an indication. If such a HA indication does not exist, patients will alternatively receive
      ST. Within these two groups (hearing aid indication - yes or no), patients will be randomly
      allocated to the intervention arms consisting of single and combinational interventions.

      Single therapy:

        -  HA (in the group stratified for hearing aids)

        -  ST

        -  SC

        -  CBT4T

      Combinational therapy:

        -  HA + ST (in the group stratified for hearing aids)

        -  HA + SC (in the group stratified for hearing aids)

        -  HA + CBT4T (in the group stratified for hearing aids)

        -  ST + SC

        -  ST + CBT4T

        -  SC + CBT4T

      Screening and baseline as well as treatment start can be performed on the same day. In this
      case relevant assessments are only performed once. In addition, blood samples can be obtained
      during screening, baseline or a separate visit before treatment begin. Blood sampling is
      voluntary and does not have influence on participation of the study. After the baseline visit
      the respective intervention will start (at latest 4 weeks after the baseline, otherwise
      baseline measurements will be repeated) and last for 12 weeks. During an interim assessment
      after 6 weeks of treatment participants have to complete health-related and tinnitus-specific
      questionnaires again plus additional assessments of adverse events. Interventions will end
      after 12 weeks with a repetition of measurements made during baseline and another evaluation
      of adverse events. A follow-up measurement is planned 9 months after the first visit
      (baseline measurement). Moreover, an additional voluntary follow-up assessment can be done 12
      months after the first visit. Each visit will have a duration of approximately 2-3 hours. Our
      primary outcome will focus on changes in tinnitus distress measured via the Tinnitus Handicap
      Inventory (THI; (Newman et al., 1996)). Participants can choose to cancel their participation
      in the study at any point without reasons or any disadvantages except the missing treatment.
      Intervention for a single participant can be cancelled in the case of a significant
      deterioration of tinnitus symptoms. Slight worsening might be possible but expected to
      short-term. In case of worsening, participants receive support by trained medical and
      psychological experts. Prior to the start of the study, it will be registered in
      clinicaltrials.gov. For detailed information about the study procedure, interventions and
      used measurement please see the attached "UNITI - clinical investigation plan".

      Sample A planned sample size of N = 100 patients in Regensburg will be recruited from the
      clinic and polyclinic for ear, nose and throat medicine as well as from the clinic and
      polyclinic for psychiatry and psychotherapy both part of the University of Regensburg.
      Additional recruitment strategies such as marketing via newspaper etc. are planned.
    

Intervention name(s): Structured counseling; Hearing aids; Cognitive behavioral therapy; Sound therapy
Intervention type(s): Other; Device; Other; Other
Intervention description(s): Structured patient education and counselling is considered as providing information to patients in order to empower them to better manage their disorder; Hearing aids are considered medical devices and are recommended to patients with a certain degree of hearing loss. Hearing aids amplify environmental sounds.; This is a structured intervention and consists of a several week program both with noise exposure and structured interviews and expert-patient as well as patient-patient interaction in groups; Several sounds and music are used for tinnitus disorder
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four different types of interventions will be included in the RCT. Two of them mainly target on the auditory aspects of tinnitus (hearing aid fitting and sound therapy), whereas the other two mainly target the CNS (Structured Counselling and Cognitive Behavioral Therapy).
Masking: None (Open Label)
Primary purpose: Treatment