Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Insomnia severity index(ISI)
研究概览
简要总结
The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in Korea. The study design is a single site, single-armed exploratory study. Insomnia patients received a 20-minute daily sessions of the Cefaly for 4 weeks. Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, improvements in polysomnography measures, and changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity
详细描述
Insomnia is well-known for its association with adverse health outcomes. Although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics. Trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal. Insomnia patients enrolled in the study will go through a 20-minute daily session of the Cefaly device(originally FDA-approved device for migraine, which electrically modulates trigeminal nerve) for 4 weeks. The objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect, validation measures involving subjective measures(Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale), objective measures(Polysomnography measures) and neuroimaging(changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have adequately understood the whole study procedures within age range of 19-64 years
- •Patients with insomnia severity index (ISI) score of more than 15
排除标准
- •Cognitive impairment
- •Psychiatric disorders or neurological disorders.
- •Unstable medical conditions
- •Prior diagnosis of sleep disorders
- •Hypnotic prescription
- •History of brain or facial trauma within 3 months
- •Skin abrasions
- •Acrylic acid allergy
- •Electromagnetic hypersensitivity
- •Apnea hypopnea index of >15/hour in the baseline polysomnography.
结局指标
主要结局
Insomnia severity index(ISI)
时间窗: 4 weeks after intervention
Changes in Insomnia severity index scores ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity.
Pittsburgh sleep quality index(PSQI)
时间窗: 4 weeks after intervention
Changes in Pittsburgh sleep quality index scores PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance.
Epworth sleepiness scale(ESS)
时间窗: 4 weeks after intervention
Changes in Epworth sleepiness scale scores Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.
Polysomnography measures-1 (Total sleep time)
时间窗: 4 weeks after intervention
Changes in Total sleep time
Polysomnography measures-4(Stage 2 sleep period)
时间窗: 4 weeks after intervention
Changes in Stage 2 sleep period
Polysomnography measures-2 (Wake after sleep onset)
时间窗: 4 weeks after intervention
Changes in Wake after sleep onset
Polysomnography measures-3( Stage 1 sleep period)
时间窗: 4 weeks after intervention
Changes in Stage 1 sleep period
Polysomnography measures-5(Stage 3 sleep period)
时间窗: 4 weeks after intervention
Changes in Stage 3 sleep period
Polysomnography measures-8(Sleep latency)
时间窗: 4 weeks after intervention
Changes in Sleep latency
Polysomnography measures-6(Total rapid eye movement sleep period)
时间窗: 4 weeks after intervention
Changes in Total rapid eye movement sleep period
Polysomnography measures-7(Rapid eye movement sleep latency)
时间窗: 4 weeks after intervention
Changes in Rapid eye movement sleep latency
Polysomnography measures-9(Apnea hypopnea index)
时间窗: 4 weeks after intervention
Changes in Apnea hypopnea index
Neuroimaging parameter changes-2(Cortical thickness)
时间窗: 4 weeks after intervention
Changes in Cortical thickness
Neuroimaging parameter changes-4(Fractional anisotropy)
时间窗: 4 weeks after intervention
Changes in Fractional anisotropy
Neuroimaging parameter changes-5(Mean diffusivity)
时间窗: 4 weeks after intervention
Changes in Mean diffusivity
Neuroimaging parameter changes-1(Resting state network functional connectivity)
时间窗: 4 weeks after intervention
Resting state network functional connectivity changes
次要结局
未报告次要终点
研究者
Yoo Hyun Um
Clinical Assistant Professor
Saint Vincent's Hospital, Korea