Virtual Reality and Subjective Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Subjective Tinnitus Severity Scale (S.T.S.S.)
研究概览
简要总结
The purpose of this study is to test if virtual reality immersion has the potential to significantly decrease subjective tinnitus intrusiveness when compared to standard care.
详细描述
This is a randomised controlled study aimed at further validating the use of Virtual Reality in the field of subjective tinnitus management. Indeed, earlier results have suggested that this innovative strategy has the potential to be as efficient as a Cognitive and Behavioural Therapy.
Before the sessions, an automated tinnitus matching procedure will help create a sound similar to the tinnitus percept ("Tinnitus Avatar").
During the sessions (8 sessions; 30 minutes), the "Tinnitus Avatar" will be displayed auditorily but also visually - as a sparkling spot - in a variety of virtual 3D auditory and visual environments.
In these virtual environments the patients will be given the possibility to voluntarily control and manipulate the "Tinnitus Avatar" by the means of a wand on top of which the sound and the sparkling will be attached. They will also be able to freely navigate in the virtual scenes where environmental sound will be displayed.
Then the patients will be able to displace at will the "Tinnitus Avatar" in their peri-personal space or mask it by getting close to sounds they may encounter in the virtual scenes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 75 years,
- •French speaking and ability to understand multidimensional questionnaires,
- •Subjective tinnitus of peripheral origin (middle or inner ear auditory nerve)
- •Subjective tinnitus stable and chronic (lasting for more than 6 months)
- •Subjective tinnitus that can be characterized by tinnitus matching
- •Normal hearing or moderate hearing loss
排除标准
- •Fluctuating tinnitus,
- •Unilateral or bilateral severe or profound hearing loss,
- •Claustrophobia, visual, impairment, vertigo or dizziness, chronic headache or any other condition contraindicating virtual immersion
- •Psychiatric condition requiring immediate management
- •Pregnant or breastfeeding women
- •Protected adults (including individual under guardianship by court order)
- •Persons deprived of their liberty by judicial or administrative decision
结局指标
主要结局
Subjective Tinnitus Severity Scale (S.T.S.S.)
时间窗: 5 months
16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)
次要结局
- Tinnitus Handicap Questionnaire (THI)(5 months)
- Visual Analog Scale Tinnitus Loudness(5 months)
- Hospital Anxiety Depression Scale(5 months)
- Visual Analog Scale Tinnitus Intrusiveness(5 months)