Clinical Efficacy and Mechanism of High Definition tDCS Based on dmPFC in the Intervention of Chronic Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- daytime sleepiness assessed by the FFS
研究概览
简要总结
To investigate the intervention effect of transcranial direct current stimulation (tDCS) on subjective and objective insomnia symptoms and daytime function of chronic insomnia patients.
详细描述
Fifty patients with chronic insomnia disorder diagnosed by the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017) were recruited from the first affiliated Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the subjective measures consisting of sleep questionnaires, polysomnography (PSG) and tDCS treatment conducted by trained researchers at the Neurology Department of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode electrode was placed on the DMPFC (Fz) surrounded by four cathodes with a 1cm diameter (FPz, F3, Cz, and F4). Each participant received 30 min of tDCS stimulation once daily for 10 consecutive days. The stimulation direct current magnitude was set at 2 mA in the active group. In the sham intervention phase, the sensation was simulated by applying a 30s rising current until 2 mA was reached, with a 30s immediate decline at the beginning and end of each phase.
At the beginning and after a 10-day intervention, subjective measures consisting of sleep questionnaires, including the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI), were assessed. The Flinders Fatigue Scale (FFS) and the Epworth Sleepiness Scale (ESS) were used to assess daytime sleepiness. Additionally, the HAMA and HAMD were used synchronously for emotional assessment. Afterwards, they were unblinded by the study coordinator.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 15 and 65 years,
- •diagnosed with chronic insomnia based on the Diagnostic Criteria and Treatment Guidelines for Adult Insomnia (2017),
- •no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.
排除标准
- •diagnosis of other sleep disorders, such as sleep apnoea-hypopnoea syndrome, REM behaviour disorder, and restless legs syndrome,
- •history of head trauma or presence of serious organic diseases,
- •presence of comorbid anxiety or depression, as assessed by a Hamilton Anxiety Scale [HAMA] score of 17 or Hamilton Depression Scale [HAMD] score of 14.
研究组 & 干预措施
real stimulation
Participants will receive active HD-tDCS daily for 10 consecutive days. The anode electrode was placed on the DMPFC (Fz) surrounded by four cathodes with a 1cm diameter (FPz, F3, Cz, and F4). The stimulation direct current magnitude was set at 2 mA with a 30-s immediate decline at the beginning and end of each phase.
干预措施: transcranial direct current stimulation (Device)
sham stimulation
In the sham intervention phase, the sensation was simulated by applying a 30-s rising current until 2 mA was reached, with a 30-s immediate decline at the beginning and end of each phase.
干预措施: sham transcranial direct current stimulation (Device)
结局指标
主要结局
daytime sleepiness assessed by the FFS
时间窗: before and after 10-day intervention
the Fatigue Severity Scale (FFS) is a 7-item scale to measure daytime sleepiness, where each item is rated on a scale from 0 to 3. The FFS total score ranges from 0 to 31, the higher the score indicates the more serious daytime sleepiness.
subjective sleep quality assessed by the ISI
时间窗: before and after 10-day intervention
The Insomnia Severity Index (ISI) is a 7-item scale to measure insomnia symptoms, where each item is rated on a scale from 0 to 4. The ISI total score ranges from 0 to 28, The higher the score indicates the more worse sleep quality.
daytime sleepiness assessed by the ESS
时间窗: before and after 10-day intervention
The Epworth Sleepiness Scale (ESS) is a 8-item scale to measure daytime sleepiness, where each item is rated on a scale from 0 to 3. The ESS total score ranges from 0 to 23, the higher the score indicates the more serious daytime sleepiness.
subjective sleep quality assessed by the PSQI
时间窗: before and after 10-day intervention
The Pittsburgh Sleep Quality Index (PSQI) consist of 18 items divided into 7 dimensions, such as sleep duration, sleep efficiency, sleep disorders and daytime dysfunction. The PSQI total score ranges from 0 to 21, the higher the score indicates the more worse sleep quality.
objective sleep quality assessed by the PSG
时间窗: before and after 10-day intervention
the change of objective sleep quality assessed by polysomnography(PSG) will constitute the major research outcome measure, to assess response to tDCS. Recorded details included data on SOL(sleep onset latency), TST(total sleep time), WASO(wake after sleep onset), EF(sleep Efficiency), and percentages of slow-wave sleep, stage 2 sleep, stage 1 sleep, and REM sleep.
次要结局
- emotional symptoms assessed by the HAMD(before and after 10-day intervention)
- emotional symptoms assessed by the HAMA(before and after 10-day intervention)
研究者
WANG KAI
Director of medical psychological department
Anhui Medical University