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Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 20 Years - 65 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05518942 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Taipei Medical University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Benign Brain Tumor, Neurofeedback, Insomnia |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Hsiao-Yean Chiu, PhD
For additional contact information, you can also visit the trial on clinicaltrials.gov.