Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modulation Index
研究概览
简要总结
Sleep is ubiquitous in animals and humans, and disruptions are of high clinical importance. Still, the neural basis of sleep perception is insufficiently understood, which limits the development of new treatments. The current project is designed to further contribute to the understanding of the neural basis of sleep perception and to the development of innovative treatments for disrupted sleep (insomnia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
- •Age 18 to 65 years
- •Written informed consent
排除标准
- •Relevant current or past serious medical disorder, including but not limited to cardiac arrhythmia, diabetes mellitus, and chronic pain conditions.
- •Neurological conditions including epilepsy, history of brain injury, encephalitis or any organic brain syndrome
- •Current or past mental disorders (life time prevalence), e.g. depressive disorder, attention deficit disorder, psychotic disorders, anxiety disorder, posttraumatic stress disorder
- •Sleep disorders (except ID for patients), including movement-related sleep disorders (PLMS index with arousal > 5) or breathing-related sleep disorders (AHI > 15)
- •Intake of CNS active medication (except appropriate thyroid hormone substitution)
- •Current or past substance abuse or dependency
- •Smoking > 5 cigarettes per day
- •Excessive caffeine consumption (> 500 mg or 5 cups coffee per day)
- •Irregular sleep schedules resulting from shift work, travelling or personal habits, defined as a sleep/wake time deviation > 4 hours in the weekly routine or as a habitual total sleep time < 4.5 hours or > 10 hours per night
- •Known pregnancy
研究组 & 干预措施
Patients with insomnia
Patients with insomnia disorder according to DSM-5 criteria
干预措施: Auditory closed-loop stimulation: slow oscillation boosting (Device)
Patients with insomnia
Patients with insomnia disorder according to DSM-5 criteria
干预措施: Auditory closed-loop stimulation: slow oscillation disruption (Device)
Patients with insomnia
Patients with insomnia disorder according to DSM-5 criteria
干预措施: Sham stimulation (Device)
Healthy controls
Healthy controls
干预措施: Auditory closed-loop stimulation: slow oscillation boosting (Device)
Healthy controls
Healthy controls
干预措施: Auditory closed-loop stimulation: slow oscillation disruption (Device)
Healthy controls
Healthy controls
干预措施: Sham stimulation (Device)
结局指标
主要结局
Modulation Index
时间窗: Averaged across NREM sleep of the baseline night (about 6 hours)
Measure of phase-amplitude coupling
次要结局
未报告次要终点
研究者
Christoph Nissen
Chief physician
University of Bern