The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Improving Sleep Quality in Adults Without Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on
Improving Sleep Quality in Adults Without Serious Mental Illness
Introduction
The investigators would like to invite participants to participate in a study on the efficacy of using magnetic fields to improve sleep quality in adults with no serious mental illness.
The research leader is Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Queen Mary Hospital/ HKU Li Ka Shing Faculty of Medicine.
Please read the following information carefully. If necessary, participants can discuss with relatives, friends or doctors. If anything is unclear, or if participants would like more information, please ask us. Please carefully consider whether participants are willing to participate in this research.
Research Purpose
Sleep is a fundamental component of overall health and well-being, playing a crucial role in cognitive function, emotional regulation, and physical health. However, sleep complaints are common, even among otherwise healthy adults, often leading to reduced quality of life and increased health risks. The prevalence of poor sleep quality can be attributed to a variety of factors, including stress, lifestyle habits, and environmental disturbances.
rTMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity in targeted brain regions. Over the years, rTMS has shown promise in treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD) and clinical insomnia.
Research Methods
Participants
Healthy adults aged 18-65 with self-reported sleep complaints.
Treatment protocol
Six sessions of rTMS using the EXOMIND™ device, administered once or twice a week.
Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds.
The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in the research centre with medical staff supported.
A checklist of potential adverse effects from TMS administration will be referenced from existing literature to monitor tolerability and adverse events during each session. Blood pressure and heart rate will be recorded at the beginning and end of each session.
Assessment
Participants will be assessed at three time points: baseline (pre-intervention), post-intervention, and four weeks post-intervention.
Assessments: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Patient Health Questionnaire-9 (PHQ-9), and home sleep monitoring device.
Demographics: age, gender, years of education, place of birth, marital status, number of children, financial condition, household income, family history of sleep difficulties will be collected upon study entry. Medical history in relation to mental illnesses and medications will also be assessed.
详细描述
Risks of Participation
Participants may experience mild discomfort from brain stimulation treatment. A small percentage of users may experience dizziness, headache, or nausea. The side effects of brain pulse stimulation therapy are short-lived and are not known to cause any permanent damage. If participants feel unwell after completing the brain pulse stimulation treatment, please inform the staff and therapist.
Note: Patients who have had metal implants in the head, neck, or upper back, or who have had metal teeth/dental trays or pacemakers, should not receive brain stimulation.
Benefits of Participation
The investigators sincerely invite participants to participate in this study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adults
- •Aged between 18-65
- •Self-reported sleep complaints
排除标准
- •Serious mental illness other than primary insomnia
- •Severe neurological conditions
- •Contraindications for rTMS.
研究组 & 干预措施
healthy adults
干预措施: rtms (Device)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Using Pittsburgh Sleep Quality Index (PSQI) to measure subjective sleep quality In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention
Using Pittsburgh Sleep Quality Index (PSQI) to measure subjective sleep quality In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
次要结局
- Perceived Stress Scale (PSS)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
- Sleep time and stages(Baseline: 7 consecutive nights before the rTMS intervention starts Post-intervention: 7 consecutive nights after the last session rTMS intervention)
- Perceived Stress Scale (PSS)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
- Sleep time and stages(Baseline: 7 consecutive nights before the rTMS intervention starts Post-intervention: 7 consecutive nights after the last session rTMS intervention)
研究者
Dr. Cheng Pak Wing, Calvin
Clinical Assistant Professor
The University of Hong Kong