Sleep DeprivationNEUROWAKENCT04591314
Evaluation of the Effect of Neurofeedback Targeting EEG Theta / Beta Activities on the Strengthening of Wakefulness Maintenance Capacities and Cognitive Performance.
A study testing Neurofeedback in people with Sleep Deprivation, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 has been used to regulate EEG amplitude in certain spectral bands, which correlate with the degree of neural synchronization. Neurofeedback makes it possible in particular to reduce the amplitude of the EEG theta spectral band (4-8 Hz) and to increase the EEG beta spectral band (> 12Hz).
This type of protocol has been used successfully to reduce the degree of neural synchronization and to stimulate arousal systems and sustained attention skills.
Studies on healthy subjects submitted to controlled sleep deprivation have shown that inducing a full night of sleep deprivation is a good model for studying the brain mechanisms of arousal and the links with cognitive functions, but also to assess the effectiveness of counter measures reducing the impact of sleep deprivation on cognitive performance. These experimental models provide a better understanding of the mechanisms and consequences of the complaint of excessive daytime sleepiness (EDS). EDS is indeed a frequent symptom affecting between 5% and 8% of the population. The consequence of EDS is a decrease in quality of life. In addition, the EDS entails a high medico-economic cost because of the accidental risk of the public and professional roads.
Neurofeedback could, through its impact on the degree of neuronal synchronization, help to reduce the impact of sleep deprivation on wakefulness and cognitive performance. Thus, it appears relevant to assess the effectiveness of neurofeedback, targeting activities in the theta / beta EEG spectral band, on wakefulness and cognitive performance in healthy subjects with EDS due to sleep deprivation. Targeting the degree of neuronal EEG synchronization would then be an innovative avenue for improving the physiological mobilization of arousal systems and wakefulness and cognitive performance in the event of EDS. This cognitive remediation technique could in particular be proposed as a complement to pharmacological treatment in treated patients suffering from hypersomnolence disorder presenting a residual EDS.
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.
The secondary objectives are:
- To study the effect of a program of 8 sessions of neurofeedback targeting theta / beta EEG activities, in healthy subjects after a full night of sleep deprivation presenting objective excessive daytime sleepiness, on the instantaneous subjective arousal level in a situation controlled (MWT and neurofeedback session) by the Karolinska sleepiness scale (KSS).
- To study the effect of a program of 8 sessions of neurofeedback targeting theta / beta EEG activities, in healthy subjects after a full night of sleep deprivation presenting objective excessive daytime sleepiness, on the cognitive performance, before and after neurofeedback sessions, assessed by the Psychomotor Vigilance Task (PVT) and by the Test of Attentional Performance (TAP).
- To study the functional reorganization of the EEG activities of the brain, in particular the degree of neuronal synchronization between the different regions of the scalp, in subjects presenting objective excessive daytime sleepiness after a full night of sleep deprivation and following a program of 8 neurofeedback sessions targeting EEG theta / beta activities.
- To study a learning effect during the 8 neurofeedback sessions evaluated by measuring the evolution of the modulation of the spectral power in the theta / beta band during each neurofeedback session.
- To study the prognostic learning factors during the 8 neurofeedback sessions.
- To study the prognostic factors for clinical improvement of MWT, subjective EDS and cognitive performance.
- Conditions
- Sleep Deprivation
- Being tested
- Neurofeedback
- Keywords
- Neurofeedback; electroencephalography; sleep deprivation; maintenance wakefulness test; cognitive performance; learning modulation; arousal system.
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback participants | Experimental | All the participants studied. Receives: Behavioral: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance Wakefulness Test
Mean latency on the Maintenance Wakefulness Test (MWT) after a full night of sleep deprivation.
Measured: 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])
Secondary outcomes (3)
Karolinska Sleepiness Scale
Subjective daytime wakefulness level. minimum value 1 (extremely alert); maximum value 9 (extremely sleepy, fighting sleep)
Measured: 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)
Psychomotor Vigilance Task (PVT),
Measured: At inclusion [day 0] and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])
Cognitive performance (2)
Test of Attention Performance (TAP)
Measured: At inclusion [day 0] and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start6 Jan 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591314
- Sponsor's protocol ID
- CHUBX 2020/28
- Other IDs
- 2020-A01848-31
- Acronym
- NEUROWAKE
- Status last verified
- Jun 2024
- First submitted
- 13 Oct 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Neurofeedback Targeting EEG Theta / Beta Activities on the Strengthening of Wakefulness Maintenance Capacities and Cognitive Performance.
- ClinicalTrials.gov ID
- NCT04591314
- Acronym / sponsor ID
- NEUROWAKE / CHUBX 2020/28
- Conditions
- Sleep Deprivation
- Keywords
- Neurofeedback; electroencephalography; sleep deprivation; maintenance wakefulness test; cognitive performance; learning modulation; arousal system.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 has been used to regulate EEG amplitude in certain spectral bands, which correlate with the degree of neural synchronization. Neurofeedback makes it possible in particular to reduce the amplitude of the EEG theta spectral band (4-8 Hz) and to increase the EEG beta spectral band (> 12Hz).
This type of protocol has been used successfully to reduce the degree of neural synchronization and to stimulate arousal systems and sustained attention skills.
Studies on healthy subjects submitted to controlled sleep deprivation have shown that inducing a full night of sleep deprivation is a good model for studying the brain mechanisms of arousal and the links with cognitive functions, but also to assess the effectiveness of counter measures reducing the impact of sleep deprivation on cognitive performance. These experimental models provide a better understanding of the mechanisms and consequences of the complaint of excessive daytime sleepiness (EDS). EDS is indeed a frequent symptom affecting between 5% and 8% of the population. The consequence of EDS is a decrease in quality of life. In addition, the EDS entails a high medico-economic cost because of the accidental risk of the public and professional roads.
Neurofeedback could, through its impact on the degree of neuronal synchronization, help to reduce the impact of sleep deprivation on wakefulness and cognitive performance. Thus, it appears relevant to assess the effectiveness of neurofeedback, targeting activities in the theta / beta EEG spectral band, on wakefulness and cognitive performance in healthy subjects with EDS due to sleep deprivation. Targeting the degree of neuronal EEG synchronization would then be an innovative avenue for improving the physiological mobilization of arousal systems and wakefulness and cognitive performance in the event of EDS. This cognitive remediation technique could in particular be proposed as a complement to pharmacological treatment in treated patients suffering from hypersomnolence disorder presenting a residual EDS.
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.
The secondary objectives are:
- To study the effect of a program of 8 sessions of neurofeedback targeting theta / beta EEG activities, in healthy subjects after a full night of sleep deprivation presenting objective excessive daytime sleepiness, on the instantaneous subjective arousal level in a situation controlled (MWT and neurofeedback session) by the Karolinska sleepiness scale (KSS).
- To study the effect of a program of 8 sessions of neurofeedback targeting theta / beta EEG activities, in healthy subjects after a full night of sleep deprivation presenting objective excessive daytime sleepiness, on the cognitive performance, before and after neurofeedback sessions, assessed by the Psychomotor Vigilance Task (PVT) and by the Test of Attentional Performance (TAP).
- To study the functional reorganization of the EEG activities of the brain, in particular the degree of neuronal synchronization between the different regions of the scalp, in subjects presenting objective excessive daytime sleepiness after a full night of sleep deprivation and following a program of 8 neurofeedback sessions targeting EEG theta / beta activities.
- To study a learning effect during the 8 neurofeedback sessions evaluated by measuring the evolution of the modulation of the spectral power in the theta / beta band during each neurofeedback session.
- To study the prognostic learning factors during the 8 neurofeedback sessions.
- To study the prognostic factors for clinical improvement of MWT, subjective EDS and cognitive performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback participants | Experimental | Behavioral: NeurofeedbackAll the participants studied. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackThe 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. | Behavioural | Neurofeedback participants |
Primary outcome
Maintenance Wakefulness Test
Time frame: 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])
Mean latency on the Maintenance Wakefulness Test (MWT) after a full night of sleep deprivation.
3 secondary outcomes
Karolinska Sleepiness Scale
Time frame: 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)
Time frame: At inclusion [day 0] and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])
Cognitive performance (2)
Time frame: At inclusion [day 0] and 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Sleep Deprivation, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance Wakefulness Test (time frame: 1 week after the end of the neurofeedback program (6 weeks after inclusion [day 0])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.