UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The effects of interventions in tinnitus distress
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary complaint tinnitus
- •Chronic tinnitus (for at least 6 months based on history)
- •Age 18-80 years
- •Ability to understand and consent to the research / ability to participate (hearing ability, intellectual capacity, no plans for sabbaticals or long-term holidays, no (plans for) pregnancy)
- •A score of >22 on the Montreal Cognitive Assessment (MoCa), i.e. adults without mild cognitive impairment
- •Ability and willingness to use the UNITI mobile applications on their smartphones
- •A score of ≥ 18 in the Tinnitus Handicap Inventory (THI) of Newman et al. (1996)
- •Willing to use a hearing aid (if indication)
- •If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
排除标准
- •Objective tinnitus / heartbeat-synchronous tinnitus as primary complaint
- •Start of any other tinnitus related treatments, especially hearing aids, structured counseling, sound therapy (with special devices; expecting long term effects) or cognitive behavioral therapy in the last 3 months before the start of the study
- •Otosclerosis / acoustic neuroma or other relevant ear disorders with fluctuation hearing
- •Present acute infections (acute otitis media, otitis externa, acute sinusitis)
- •Meniere's disease or similar syndromes (but not vestibular migraine)
- •Serious internal, neurological or psychiatric conditions
- •Epilepsy or other CNS disorders (brain tumor, encephalitis)
- •Clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start
- •Missing written informed consent
- •Severe hearing loss - inability to communicate properly in the course of the study
- •One deaf ear
结局指标
主要结局
The effects of interventions in tinnitus distress
时间窗: Through study completion, an average of 22 months
The primary outcome will cover the domain tinnitus distress. The total score in the Tinnitus Handicap Inventory (THI; Newman et al., (1996)) is defined as the primary outcome measure for tinnitus distress.
次要结局
未报告次要终点