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COMPLETED

NCT04591314

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-06

Completion Date

2024-05-31

Last Updated

2026-05-20

Healthy Volunteers

Yes

Conditions

Sleep Deprivation

Interventions

BEHAVIORAL

Neurofeedback

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.

Inclusion Criteria: * 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) * Presence of an objective EDS measured by a mean sleep latency of less than 30 minutes on the wakefulness maintenance test performed after a night of total sleep deprivation under controlled conditions (at the inclusion visit), * 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. Exclusion Criteria: * 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, * A person participating in another research study with an exclusion period still in progress, * Person whose physical and/or psychological health is severely impaired

Locations (1)

CHU de Bordeaux

Bordeaux, France