Effects of Sensorimotor Rhythm Neurofeedback on Insomnia in Patients With Benign Brain Tumors Underwent Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
研究概览
简要总结
Insomnia is the most common sleep disorder in patients with primary brain tumors. In the past, 21.5% to 59.2% of patients with primary brain tumors suffer from insomnia symptoms. In addition to hypnotics, nonpharmacological interventions for insomnia in patients with brain tumors are still lacking. When using hypnotics may cause daytime sleepiness, cognitive impairment, and increase the risk of cancer, seeking an effective intervention is of clinical importance. Sensorimotor rhythm neurofeedback therapy has been shown to improve insomnia in different populations. However, its effect on insomnia has not been explored in patients with brain tumors. We, therefore, aim to investigate the feasibility and effect of sensorimotor rhythm neurofeedback in improving insomnia in patients with benign brain tumors after surgery and to examine the correlation between the degree of insomnia improvement and quality of life changes after receiving sensorimotor rhythm neurofeedback.
详细描述
Brain tumors are mainly divided into primary and metastatic, and are further divided into benign and malignant according to the pathological type. Among them, meningioma and pituitary tumor are the top two most common primary benign brain tumors, accounting for 36.1% respectively. -54.5% and 10-15%, while the most malignant glioblastoma accounts for 45-49.1% of primary malignant brain tumors. Among them, glioblastomas are more common in men and meningiomas are more common in women.
Insomnia is the most common sleep disorder in patients with primary brain tumors. Insomnia refers to difficulty falling asleep, staying awake and unable to fall asleep while sleeping, frequently waking up during sleep period or shortening sleep time, resulting in still feeling tired after getting up and affecting daily life functions. In the past, in terms of the prevalence of insomnia, primary brain 21.5%~59.2% of patients with tumor had insomnia symptoms, and if subdivided into benign, 46.8% of patients with primary benign brain tumor.
According to the results of the study, patients with primary brain tumors still have widespread and persistent insomnia problems after treatment, and even up to one year after surgery, there are still studies showing insomnia problems. Savard et al (2011) reported that insomnia is also a cancer A common and persistent problem among patients, the attack rate of insomnia generally decreased over time, but remained prevalent (36%) even at the end of 18 months. However, in real life, although insomnia has a high attack rate and a high burden on the family, and even affects the overall quality of life of patients, it is often not valued and treated.
Neurofeedback (NFB), also known as brain wave training, is a method to help subjects consciously control their brain waves. In order to reflect the state of brain activity, the software analyzes the measured brain waves and provides feedback signals to teach individuals to self-regulate brain waves. After repeated training, the target brain waves can be generated. When the threshold is reached, it will give visual and auditory feedback. Neurofeedback has been used clinically in many diseases and healthy individuals that cannot be effectively treated with drugs, such as insomnia, ADHD, epilepsy, fibromyalgia, depression, anxiety, pain, learning and memory, etc. For insomnia, the use of neurofeedback therapy can help people who usually take an hour or so to fall asleep fall asleep faster.
According to Lambert-Beaudet et al. (2021) reviewing the latest research on the use of neurofeedback in the treatment of insomnia, the enhancement of sensorimotor rhythm neurofeedback to improve insomnia was the most included and confirmed to improve insomnia. And multiple studies have confirmed that sensorimotor rhythm neurofeedback enhancement training can lead to increased sleep spindle density, decreased sleep onset latency, increased total sleep time, and decreased wake-up after falling asleep. Therefore, sensorimotor rhythm neurofeedback enhancement training can be an effective method for non-drug intervention in the treatment of insomnia. Given that the effects of sensorimotor rhythm neurofeedback training on insomnia have not been studied in patients with benign brain tumors after surgery, further studies in this group are warranted.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as primary benign brain tumors such as: meningioma, schwannoma, pituitary tumor, craniopharyngioma according to the results of pathological tissue sections and has completed treatment such as : Surgery, radiation therapy, etc. for at least 7 days.
- •Aged from 20 to 65 years old and conscious, able to communicate in Mandarin and Taiwanese.
- •Cognitive ability sufficient to complete the questionnaire.
- •Complaints of insomnia and ISI score ≥ 8
排除标准
- •Long-term shift workers one month before the included study.
- •Pregnant women.
- •Jet lag workers, such as airline workers.
- •Vision, hearing or motor dysfunction is severe enough to affect the participating researcher.
- •Preoperative diagnosis of insomnia or long-term use of sleep aids or psychiatric drugs.
结局指标
主要结局
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
时间窗: at baseline and the 10th week after Intervention finished
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Insomnia Severity
时间窗: at baseline and the 10th week after Intervention finished
The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of \> 7 is used to diagnose subthreshold insomnia.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
时间窗: at baseline and the 10th week after Intervention finished
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
时间窗: at baseline and the 10th week after Intervention finished
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
时间窗: at baseline and the 10th week after Intervention finished
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
次要结局
- changes in quality of life(at baseline and the 10th week after Intervention finished)
- Changes in Anxiety(at baseline and the 10th week after Intervention finished)
- Changes in Stress(at baseline and the 10th week after Intervention finished)
- Changes in Depression(at baseline and the 10th week after Intervention finished)
研究者
Hsiao-Yean Chiu
Associate Professor
Taipei Medical University
