Clinical trial NCT05518942: Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors
Official title: Effects of Sensorimotor Rhythm Neurofeedback on Insomnia in Patients With Benign Brain Tumors Underwent Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Brain Tumor
Neurofeedback
Insomnia
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Insomnia Severity
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Sleep parameters from sleep logs: total sleep time(TST)
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
timeFrame: at baseline and the 10th week after Intervention finished
Secondary outcomes:
measure: changes in quality of life
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Depression
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Anxiety
timeFrame: at baseline and the 10th week after Intervention finished
measure: Changes in Stress
timeFrame: at baseline and the 10th week after Intervention finished
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital.
Study officials:
References: