Evaluation of the Effect of Neurofeedback Targeting EEG Theta / Beta Activities on the Strengthening of Wakefulness Maintenance Capacities and Cognitive Performance.

NCT04591314 | Completed

• 2 other identifiers: CHUBX 2020/282020-A01848-31
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Neurofeedback is a cognitive remediation technique that allows a subject to learn to regulate their cognitive and brain activity through information provided in real time about their brain activity, in particular electroencephalographic (EEG) brain activity. Neurofeedback could, through its impact on the degree of neuronal synchronization, help to reduce the impact of sleep deprivation on wakefulness and cognitive performance. The main objective is to study the effect of a program of 8 sessions of neurofeedback targeting EEG theta / beta activities, to modify the degree of neuronal synchronization, on the ability to maintain objective wakefulness measured by a maintenance wakefulness test (MWT) in healthy subjects presenting objective excessive daytime sleepiness after a full night of sleep deprivation under controlled experimental conditions. The objective of this study will also provide a better understanding of the learning modulation mechanisms of arousal systems.

Conditions

Sleep Deprivation

Keywords

Neurofeedback; electroencephalography; sleep deprivation; maintenance wakefulness test; cognitive performance; learning modulation; arousal system.

Outcome Measures

Primary Outcomes (1)

• Maintenance Wakefulness Test

  Mean latency on the Maintenance Wakefulness Test (MWT) after a full night of sleep deprivation.

  1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])

Secondary Outcomes (3)

• Karolinska Sleepiness Scale

  At inclusion [day 0], each neurofeedback sessions (weeks 1,2,3,4,5), and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])

• Cognitive performance (1)

  At inclusion [day 0] and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])

• Cognitive performance (2)

  At inclusion [day 0] and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])

Study Arms (1)

Neurofeedback participants

EXPERIMENTAL

All the participants studied.

Behavioral: Neurofeedback

Interventions

Neurofeedback BEHAVIORAL

The intervention by neurofeedback (NF) will consist in providing the subjects with a feedback on their EEG Theta / Beta activity in real time Each subject will perform 8 sessions of neurofeedback (1h30 / session, 40 min of effective training by neurofeedback) at an average rate of 1 to 2 sessions per week.

Neurofeedback participants

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged between 18 and 35 years old,
• Healthy subject, no pathology reported at the interview
• Absence of EDS complaints (total ESS score\<11) and sleep complaints (total Insomnia Severity Indexscore \<15)
• Motivated to carry out the program of 8 neurofeedback sessions,
• Body mass index \< 25 kg/m2,
• Affiliated with the social security (beneficiary or entitled person),
• Having been informed and having signed an informed consent.

You may not qualify if:

• All pathologies that may induce excessive daytime sleepiness: untreated narcolepsy or idiopathic hypersomnia, untreated sleep apnea syndrome, untreated restless legs syndrome, untreated periodic leg movement syndrome, unstabilized psychiatric disorders of the characterized depressive disorder type, anxiety disorders, bipolar disorder, addictive disorders (alcohol and drugs), obesity having undergone surgical treatment for less than 3 months.
• Chronic insomnia disorder
• Excessive consumption of coffee, tea, or caffeinated cola type beverages (\> 5 cups/day)
• All pathologies making interaction with the neurofeedback device potentially problematic: intellectual, visual, auditory or motor impairment, psychotic disorders, unstable cardio-respiratory diseases, neurological disease of the central nervous system, confusion, dementia,
• Any situation or treatment modifying the EEG spectral power: psychotropic treatments, night or shift work, chrono-biological disorders interfering with the level of daytime alertness, history of cranial surgery, epilepsy,
• Pregnant or breastfeeding woman,
• Persons placed under the safeguard of justice,
• Person whose physical and/or psychological health is severely impaired

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: January 6, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 20, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)