Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Tinnitus Burden
研究概览
简要总结
A study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service. Three separate questionnaires will be used to collect this data from patients at regular time intervals.
详细描述
Single-site randomised controlled study looking at tinnitus burden, insomnia severity and quality of life in adults with chronic primary subjective tinnitus when using Oto smartphone app compared with National Institute for Health and Care Excellence (NICE) approved tinnitus retraining therapy. This will be assessed objectively through questionnaires at the baseline meeting, one month, three months and six months.
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
盲法说明
researchers to data generated
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (male or female) aged over 18 years of age presenting to NHS ENT and hearing services with primary non-pulsatile tinnitus irrespective of hearing.
- •Patients must be suffering from tinnitus for a minimum of 3 months
- •Patients that have a willingness to use as well as have access to a smartphone device capable of running Oto.
- •Willing and able to provide written informed consent.
- •Those that would be offered tinnitus retraining therapy (TRT) as management for their primary tinnitus
排除标准
- •Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).
- •Patients undergoing any other tinnitus therapies concurrently (including hearing aids / implants). Previous tinnitus therapies including CBT in the past are accepted.
- •Patients who are not willing to use the app due to not having a suitable phone to download the application or due to own limitations in working Oto.
结局指标
主要结局
Tinnitus Burden
时间窗: 6 months total post intervention start date
Tinnitus burden via Tinnitus Functional Index questionnaires at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).
次要结局
- Insomnia Severity(6 months total post intervention start date)
- Quality of Life(6 months total post intervention start date)
研究者
Amir Habeeb
Principal Investigator
East and North Hertfordshire NHS Trust