Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders: a Monocentric, Randomized, Open-label, Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time to sleep
研究概览
简要总结
The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety.
Cognitive and Behavioral Therapy (CBT) is today the reference treatment recommended by the "Haute Autorité de Santé" and the American College of Physicians for chronic insomnia. Today, however, few patients use CBT treatment due to the lack of trained practitioners, the cost of non-reimbursed sessions and the time and involvement that these sessions require.
Several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. The hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in patients suffering from insomnia disorders.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from insomnia as defined in the Diagnostic and Statistical Manual of Mental Disorders V (DMS-V) and the International Classification of Sleep Disorders.
排除标准
- •Patient who, in the judgment of the investigator, has a disease that may preclude participation in study procedures.
- •Minor subject
- •Subject under judicial protection, guardianship or curatorship
- •Inability to give informed information about the subject: demented patients, psychotic patients or follow-up for a psychiatric pathology
- •Unbalanced epilepsy
- •Hearing and/or visual disorders that contraindicate the use of virtual reality headphones
- •Patient with a language barrier
- •Pregnant or breastfeeding patient
- •Subject in period of exclusion (determined by a previous or current study)
- •Patient Refusal
- •Patient currently being treated for depression, alcoholism or drug addiction.
- •Patient using drug treatment for insomnia not stabilized within 2 weeks prior to the start of the study.
- •Patient starting psychological, complementary or alternative medicine treatment for insomnia within 2 weeks prior to the start of the study, or during the study.
- •Patient receiving or having received CBT treatment for insomnia within the last 6 months.
- •Patient diagnosed with sleep apnea, involuntary limb movement, restless legs syndrome.
- •Patient with diagnosed medical conditions that cause insomnia: psychotic disorder, bipolar disorder, dementia, generalized anxiety disorder, panic disorder, manic disorder, schizophrenia, cancer.
结局指标
主要结局
Time to sleep
时间窗: after 6 weeks of treatment
Demonstrate a decrease in time to sleep after treatment, by polysomnography
次要结局
未报告次要终点