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

NCT05518942 | Terminated

• 1 other identifier: 202200998B0A3
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Brain Tumor; Neurofeedback; Insomnia

Outcome Measures

Primary Outcomes (5)

• Changes in Insomnia Severity

  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.

  at baseline and the 10th week after Intervention finished

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

  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.

  at baseline and the 10th week after Intervention finished

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

  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.

  at baseline and the 10th week after Intervention finished

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

  Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

  at baseline and the 10th week after Intervention finished

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

  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%.

  at baseline and the 10th week after Intervention finished

Secondary Outcomes (4)

• changes in quality of life

  at baseline and the 10th week after Intervention finished

• Changes in Depression

  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

Study Arms (2)

sensorimotor rhythm neurofeedback training

EXPERIMENTAL

Sensory motor rhythm neurofeedback: The subjects will perform 60 minutes per week for 10 weeks, with a total training time of 600 minutes. The intervention in this trial lasts for 10 weeks (1 time/week), with the goal of improving sensory motor rhythm. Since this training uses visual and auditory feedback, if patients are assigned to this group, they will be ask to wear an EEG cap with 19 electrodes. They can take a relaxed sitting posture and choose animations (e.g., puzzles, mazes, and other feedback content), and then focus on computer screen animation for training, each training time is approximately 60 minutes.

Behavioral: sensorimotor rhythm neurofeedback training

control group

NO INTERVENTION

Patient should maintain their usual activity and treatment. Research assistants will weekly contact them to confirm their compliance.

Interventions

sensorimotor rhythm neurofeedback training BEHAVIORAL

In this study, baseline brain waves will be recorded for 5 minutes before each treatment, and the average value of SMR waves was used as the basis for setting the treatment threshold for the week. During the treatment, the subjects are arranged to sit in front of a computer screen with a game or animation playing. The individual focuses on the games or animations on the screen. The software will analyze the brain wave signals from the brain and convert them into visual and auditory feedback on the computer screen. Clients can learn to control brain activity and give visual and auditory feedback when a set threshold is reached

sensorimotor rhythm neurofeedback training

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Brain Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: October 26, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

TW (1)