TerminatedNot Applicable

Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors

Stopped: Difficulty recruiting cases due to the epidemic

Taiwan5 participantsStarted 2022-10-26

Plain-language 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.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Insomnia Severity

Timeframe: at baseline and the 10th week after Intervention finished

Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)

Timeframe: at baseline and the 10th week after Intervention finished

Changes in Sleep parameters from sleep logs: after sleep onset(WASO)

Timeframe: at baseline and the 10th week after Intervention finished

Changes in Sleep parameters from sleep logs: total sleep time(TST)

Timeframe: at baseline and the 10th week after Intervention finished

Changes in Sleep parameters from sleep logs: sleep efficiency(SE)

Timeframe: at baseline and the 10th week after Intervention finished

Trial details

NCT IDNCT05518942

SponsorTaipei Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-19

View on ClinicalTrials.gov More Benign Brain Tumor trials