Patients With Drug-resistant Focal EpilepsyEPIDREAM 3NCT07605858
Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep
An observational study of Patients With Drug-resistant Focal Epilepsy and SEEG as Part of Presurgical Evaluation, run by Hospices Civils de Lyon at 2 sites in 2 countries.
Trial summary
Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure susceptibility. Conversely, sleep disturbances are highly prevalent in patients with epilepsy (PWE). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Patients With Drug-resistant Focal Epilepsy, SEEG as Part of Presurgical Evaluation
- What is being tested?
- Direct Electric Stimulation (DES)
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients investigated with SEEG as part of presurgical evaluation in the Department of Functional Neurology and Epileptology of the HCL, Lyon, France and in the Epilepsy Department, Duke University Hospital, Durham, USA.
Who may be able to join
- Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
- Aged 18 to 55 years old
- Diagnosis of focal temporal or frontal lobe epilepsy based on non-invasive work-up
- Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy 31
- Patients undergoing SEEG investigation
- At least 1 frontal and 1 temporal electrode in the SEEG procedure
- Patient affiliated to the French health care system
Who cannot join
- Multifocal epilepsy
- Untreated severe obstructive sleep-apnea syndrome
- Too abnormal SEEG recording interfering with sleep stage identification during the DES procedure
- Severe cognitive impairment preventing full understanding and completion of the protocol
- Unstable psychiatric condition
- Subject participating in other interventional research with an exclusion period still in progress at pre-inclusion
Show all 9Show fewer
- Persons deprived of their liberty by a judicial or administrative decision
- Adults subject to a legal protection measure (guardianship, curatorship
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Epilepsy Department, Duke University Hospital
Durham, North Carolina, 27710
Frauscher Birgit, MD, birgit.frauscher@duke.edu
France1 site, 1 recruiting
- Recruiting
Service de Neurologie Fonctionnelle et d'Epileptologie Hôpital Neurologique, GHE, Hospices Civils de Lyon Hôpital Neurologique Pierre WERTHEIMER
Bron, 69500
PETER-DEREX Laure, MD, +33 (0) 4 72 35 70 44, laure.peter-derex@chu-lyon.fr
About this study
Official title: Deciphering the Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep : EPIDREAM 3
Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure susceptibility. Conversely, sleep disturbances are highly prevalent in patients with epilepsy (PWE).
Using simultaneous stereoelectroencephalography (SEEG)-polysomnography, the investigators previously showed that sleep fragmentation in focal drug-resistant epilepsy is associated with both ictal and interictal epileptic activity, with increased interictal epileptiform discharges (IED) immediately before and during arousals. However, causality remains unclear, as sleep instability itself may promote epileptic discharges. Determining whether nocturnal seizures and IED directly induce awakenings is clinically important. Nocturnal epileptic activity is often considered less disabling than daytime seizures and rarely guides treatment decisions, yet demonstrating a direct impact on sleep continuity could support therapeutic strategies specifically targeting nocturnal epileptic activity to improve sleep quality.
Read more
Beyond sleep continuity, epilepsy may also influence cognitive processes during sleep, including subjective sleep depth and dreaming. While the cognitive consequences of epilepsy during wakefulness are well established, relationships between epileptic activity, sleep architecture and subjective sleep experiences remain poorly understood. In a survey of 300 PWE, the investigators observed altered dream recall frequency and dream content, with seizure-related dreams associated with nocturnal seizures. However, retrospective morning reports cannot establish temporal relationships between epileptic discharges and dream phenomena, nor determine the influence of discharge localization or sleep stage.
SEEG combined with direct electrical stimulation (DES) provides a unique framework to address these questions. DES is routinely used during presurgical evaluation to identify epileptogenic and eloquent cortex, but is mainly performed during wakefulness. Yet sleep modifies functional connectivity and facilitates epileptic activity, suggesting that DES during sleep may increase the sensitivity of stimulation-based localization of the seizure-onset zone.
The EPIDREAM 3 study will investigate whether DES-induced epileptic activity during sleep provokes arousals, alters dream recall or content, and modifies perceived sleep depth. It will also assess whether sleep-related DES improves delineation of epileptogenic networks, particularly in sleep-related epilepsies.
Detailed description:
Patients with frontal or temporal drug-resistant focal epilepsy investigated with SEEG as part of presurgical evaluation will be included in the Department of Functional Neurology and Epileptology of the HCL, Lyon. The investigators will use intra-cranial DES performed during the SEEG investigation to explore the impact of focal induced epileptic activity on arousal and dreams.
- DES will be first performed during wake as part of routine SEEG evaluation with the double purpose of localizing the seizure onset zone and providing a functional mapping. This step identifies channels: (i) in the assumed SOZ, where DES induces after-discharges with/without seizure symptoms; (ii) in the assumed SOZ, where DES induces no after-discharge/seizure but may induce clinical symptoms; (iii) in non-epileptic areas, where stimulation induces neither. For temporal lobe epilepsy, control channels will be selected in the frontal lobe; for frontal lobe epilepsy, in the temporal lobe
- Stimulations will be repeated in REM and NREM sleep (N2/N3) during the first two sleep cycles of a single night with simultaneous PSG.
The investigators will assess for each stimulation: (1) the precise location of the channel (2) the presence and characteristics of an induced after-discharge or seizure (3) presence of a spontaneous arousal (3-15 sec) or awakening (> 15 sec) (4) presence of objective symptoms (5) in case of awakening: presence of subjective reported symptoms, sleep depth and mind content
- Being tested
- Direct Electric Stimulation (DES)
- Keywords
- Epilepsy, Sleep, Dreams, Stereoelectroencephalography, Brain stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Electric Stimulation (DES)Other
- DES will be first performed during wake as part of routine SEEG evaluation. Bipolar stimulations of adjacent contacts will be applied using biphasic square wave pulses at low frequency and at high frequency. Intensity will be increased stepwise by increments of 0.5mA until the appearance of an objective or a subjective symptom or after-discharges or seizure.
- Stimulations will be repeated in rapid eye movement (REM) and non REM sleep during the first two cycles of a single night with simultaneous polysomnography (PSG) recording. Stimulation will involve channels from the seizure onset zone and channels outside de seizure onset zone.
If the patient wakes up following stimulations, they will be asked what was going through their mind and how deep was their sleep before awakening. If no awakening occurs but an after-discharge or a seizure is provoked, the patient will be awoken (with a maximum of 6 awakenings in REM and 6 in NREM) and also asked about sleep depth and dream content.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients investigated with SEEG as part of presurgical evaluation in the Department of Functional Neurology and Epileptology of the HCL, Lyon, France and in the Epilepsy Department, Duke University Hospital, Durham, USA. Patients recruited will be:
1. Aged 18 to 55 years old
2. Diagnosis of focal temporal or frontal lobe epilepsy based on non-invasive work-up
3. Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy
4. Patients undergoing SEEG investigation
5. At least 1 temporal and 1 frontal electrode in the SEEG procedure
6. Patient affiliated to the French health care system Receives: Other: Direct Electric Stimulation (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of arousal or awakening following DES
Rate of arousal (sudden change in the EEG pattern characterized by a shift to higher-frequency activity (e.g., alpha, beta, or theta excluding sleep spindles) lasting at least 3 seconds and preceded by at least 10 seconds of stable sleep associated with an increase in muscle tone >1sec) or awakening (>15sec) as detected on the scalp EEG or eloquent SEEG channels, following DES 1) when after-discharges or seizures were induced and 2) when no after-discharges nor seizure were induced (including all patients, all topography, seizure onset zone [SOZ] and no SOZ, triggered symptoms or not).
Measured: The time window to detect arousal or awakenings will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge.
Secondary outcomes (8)
Spectral power of the EEG following DES during sleep
Spectral power in usual frequency band of interest (delta 0.3-3.5Hz Hz, theta 4-7.5 Hz , alpha 8-11 Hz, sigma (11.5-15.5 Hz) beta (16-30 Hz), low gamma (30-40 Hz) and high gamma (50-80 Hz) during baseline and during post-stimulation recorded over all non-stimulated channels, for DES inducing after-discharges/seizures versus DES inducing no after-discharges/seizures.
Measured: baseline (pre-stimulation 10 seconds time-window) post-stimulation (the time window will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge)
Factors associated with arousal reactions
- Type or arousal reaction (no arousal/arousal/awakening)
- Factors of modulation: i) presence and type of induced epileptic activity (after-discharge vs seizure) ii) topography of the stimulated channel (within the SOZ or not; temporal vs frontal lobe, medial vs lateral) iii) anatomic extension of the induced epileptic activity (involvement of the thalamus, involvement of the cingulate cortex) iv) ongoing sleep stage (NREM vs REM sleep) v) presence of triggered symptoms as assessed during baseline wakefulness DES, iv) the type of stimulation (1 Hz vs 50 Hz, intensity in mA)
Measured: The time window to detect arousal or awakenings will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge
Dream recall during sleep following stimulations
Dream recall (yes/no) following DES inducing after-discharges or seizures versus DES not inducing after-discharges or seizures
Measured: Within the 5 minutes after the end of the DES or the after-discharge
Mental content during sleep following stimulations
Mental content (some content/no content and if content: white dream, dream including seizure symptoms, dream of seizure, dream related to epilepsy, dream unrelated to epilepsy, feeling and if feeling: related or not to epilepsy) following DES inducing after-discharges or seizures versus DES not inducing after-discharges or seizures.
Measured: Within the 5 minutes after the end of the DES or the after-discharge
Subjective sleep depth following stimulations
Sleep depth (Likert scale ranging from 0: awake, 1: drowsiness, 2: light sleep, 3: moderately deep sleep; 4: deep sleep) following DES inducing after-discharges or seizures versus DES not inducing after-discharges or seizures.
Measured: Within the 5 minutes after the end of the DES or the after-discharge
Factors associated with dream recall sleep following stimulations
- Subjective experience : dream recall
- factors of modulation: i) presence and type of induced epileptic activity (after-discharge vs seizure) ii) topography of the channel (within the SOZ or not; medial temporal vs medial frontal lobe) iii) anatomic extension of the induced epileptic activity (involvement of the thalamus, involvement of the cingulate cortex1) iv) ongoing sleep stage (NREM vs REM sleep) v) presence of triggered symptoms as assessed during baseline wakefulness DES, vi) type of stimulation (1 Hz vs 50 Hz, intensity in mA)
Measured: Within the 5 minutes after the end of the DES or the after-discharge
Factors associated with sleep depth sleep following stimulations
- Subjective experience : sleep depth
- factors of modulation: i) presence and type of induced epileptic activity (after-discharge vs seizure) ii) topography of the channel (within the SOZ or not; medial temporal vs medial frontal lobe) iii) anatomic extension of the induced epileptic activity (involvement of the thalamus, involvement of the cingulate cortex1) iv) ongoing sleep stage (NREM vs REM sleep) v) presence of triggered symptoms as assessed during baseline wakefulness DES, vi) type of stimulation (1 Hz vs 50 Hz, intensity in mA)
Measured: Within the 5 minutes after the end of the DES or the after-discharge
Sensitivity of performing DES during sleep + wake versus during wake only for delineating the seizure onset zone
In the seizure onset zone:
- Frequency of induced after-discharges and/or seizures in sleep (NREM and/or REM) + wake \& Frequency of induced after-discharges and/or seizures in wake only
- median stimulation intensity triggering an after-discharge during sleep (all sleep, and NREM and REM separately) and during wakefulness.
Measured: During wake and sleep DES sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Drug-resistant Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605858
- Sponsor's protocol ID
- 69HCL25_1045
- Other IDs
- 2026-A00170-51
- Acronym
- EPIDREAM 3
- Status last verified
- May 2026
- First submitted
- 21 Jan 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep : EPIDREAM 3
- ClinicalTrials.gov ID
- NCT07605858
- Acronym / sponsor ID
- EPIDREAM 3 / 69HCL25_1045
- Keywords
- Epilepsy, Sleep, Dreams, Stereoelectroencephalography, Brain stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 May 2026 (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.
Interactions between epilepsy and sleep are numerous and bidirectional. Sleep can facilitate epileptic activity and seizures in several syndromes, while sleep deprivation increases cortical excitability and seizure susceptibility. Conversely, sleep disturbances are highly prevalent in patients with epilepsy (PWE).
Using simultaneous stereoelectroencephalography (SEEG)-polysomnography, the investigators previously showed that sleep fragmentation in focal drug-resistant epilepsy is associated with both ictal and interictal epileptic activity, with increased interictal epileptiform discharges (IED) immediately before and during arousals. However, causality remains unclear, as sleep instability itself may promote epileptic discharges. Determining whether nocturnal seizures and IED directly induce awakenings is clinically important. Nocturnal epileptic activity is often considered less disabling than daytime seizures and rarely guides treatment decisions, yet demonstrating a direct impact on sleep continuity could support therapeutic strategies specifically targeting nocturnal epileptic activity to improve sleep quality.
Beyond sleep continuity, epilepsy may also influence cognitive processes during sleep, including subjective sleep depth and dreaming. While the cognitive consequences of epilepsy during wakefulness are well established, relationships between epileptic activity, sleep architecture and subjective sleep experiences remain poorly understood. In a survey of 300 PWE, the investigators observed altered dream recall frequency and dream content, with seizure-related dreams associated with nocturnal seizures. However, retrospective morning reports cannot establish temporal relationships between epileptic discharges and dream phenomena, nor determine the influence of discharge localization or sleep stage.
SEEG combined with direct electrical stimulation (DES) provides a unique framework to address these questions. DES is routinely used during presurgical evaluation to identify epileptogenic and eloquent cortex, but is mainly performed during wakefulness. Yet sleep modifies functional connectivity and facilitates epileptic activity, suggesting that DES during sleep may increase the sensitivity of stimulation-based localization of the seizure-onset zone.
The EPIDREAM 3 study will investigate whether DES-induced epileptic activity during sleep provokes arousals, alters dream recall or content, and modifies perceived sleep depth. It will also assess whether sleep-related DES improves delineation of epileptogenic networks, particularly in sleep-related epilepsies.
Detailed description:
Patients with frontal or temporal drug-resistant focal epilepsy investigated with SEEG as part of presurgical evaluation will be included in the Department of Functional Neurology and Epileptology of the HCL, Lyon. The investigators will use intra-cranial DES performed during the SEEG investigation to explore the impact of focal induced epileptic activity on arousal and dreams.
- DES will be first performed during wake as part of routine SEEG evaluation with the double purpose of localizing the seizure onset zone and providing a functional mapping. This step identifies channels: (i) in the assumed SOZ, where DES induces after-discharges with/without seizure symptoms; (ii) in the assumed SOZ, where DES induces no after-discharge/seizure but may induce clinical symptoms; (iii) in non-epileptic areas, where stimulation induces neither. For temporal lobe epilepsy, control channels will be selected in the frontal lobe; for frontal lobe epilepsy, in the temporal lobe
- Stimulations will be repeated in REM and NREM sleep (N2/N3) during the first two sleep cycles of a single night with simultaneous PSG.
The investigators will assess for each stimulation: (1) the precise location of the channel (2) the presence and characteristics of an induced after-discharge or seizure (3) presence of a spontaneous arousal (3-15 sec) or awakening (> 15 sec) (4) presence of objective symptoms (5) in case of awakening: presence of subjective reported symptoms, sleep depth and mind content
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Direct Electric Stimulation (DES)Patients investigated with SEEG as part of presurgical evaluation in the Department of Functional Neurology and Epileptology of the HCL, Lyon, France and in the Epilepsy Department, Duke University Hospital, Durham, USA. Patients recruited will be: 1. Aged 18 to 55 years old 2. Diagnosis of focal temporal or frontal lobe epilepsy based on non-invasive work-up 3. Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy 4. Patients undergoing SEEG investigation 5. At least 1 temporal and 1 frontal electrode in the SEEG procedure 6. Patient affiliated to the French health care system |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients investigated with SEEG as part of presurgical evaluation in the Department of Functional Neurology and Epileptology of the HCL, Lyon, France and in the Epilepsy Department, Duke University Hospital, Durham, USA.
Key inclusion criteria (7 listed)
- Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
- Aged 18 to 55 years old
- Diagnosis of focal temporal or frontal lobe epilepsy based on non-invasive work-up
- Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy 31
- Patients undergoing SEEG investigation
Key exclusion criteria (9 listed)
- Multifocal 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 |
|---|---|---|
| Direct Electric Stimulation (DES)1. DES will be first performed during wake as part of routine SEEG evaluation. Bipolar stimulations of adjacent contacts will be applied using biphasic square wave pulses at low frequency and at high frequency. Intensity will be increased stepwise by increments of 0.5mA until the appearance of an objective or a subjective symptom or after-discharges or seizure. 2. Stimulations will be repeated in rapid eye movement (REM) and non REM sleep during the first two cycles of a single night with simultaneous polysomnography (PSG) recording. Stimulation will involve channels from the seizure onset zone and channels outside de seizure onset zone. If the patient wakes up following stimulations, they will be asked what was going through their mind and how deep was their sleep before awakening. If no awakening occurs but an after-discharge or a seizure is provoked, the patient will be awoken (with a maximum of 6 awakenings in REM and 6 in NREM) and also asked about sleep depth and dream content. | Other | Patients |
Primary outcome
Rate of arousal or awakening following DES
Time frame: The time window to detect arousal or awakenings will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge.
Rate of arousal (sudden change in the EEG pattern characterized by a shift to higher-frequency activity (e.g., alpha, beta, or theta excluding sleep spindles) lasting at least 3 seconds and preceded by at least 10 seconds of stable sleep associated with an increase in muscle tone >1sec) or awakening (>15sec) as detected on the scalp EEG or eloquent SEEG channels, following DES 1) when after-discharges or seizures were induced and 2) when no after-discharges nor seizure were induced (including all patients, all topography, seizure onset zone [SOZ] and no SOZ, triggered symptoms or not).
8 secondary outcomes
Spectral power of the EEG following DES during sleep
Time frame: baseline (pre-stimulation 10 seconds time-window) post-stimulation (the time window will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge)
Factors associated with arousal reactions
Time frame: The time window to detect arousal or awakenings will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge
Dream recall during sleep following stimulations
Time frame: Within the 5 minutes after the end of the DES or the after-discharge
Mental content during sleep following stimulations
Time frame: Within the 5 minutes after the end of the DES or the after-discharge
Subjective sleep depth following stimulations
Time frame: Within the 5 minutes after the end of the DES or the after-discharge
Factors associated with dream recall sleep following stimulations
Time frame: Within the 5 minutes after the end of the DES or the after-discharge
Factors associated with sleep depth sleep following stimulations
Time frame: Within the 5 minutes after the end of the DES or the after-discharge
Sensitivity of performing DES during sleep + wake versus during wake only for delineating the seizure onset zone
Time frame: During wake and sleep DES sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Drug-resistant Focal Epilepsy and SEEG as Part of Presurgical Evaluation, run by Hospices Civils de Lyon at 2 sites in 2 countries.
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 7 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: looking for participants now, as of the sponsor's last update on 26 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 2 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PETER-DEREX MD Laure, MD (+33 (0) 4 72 35 70 44, laure.peter-derex@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of arousal or awakening following DES (time frame: The time window to detect arousal or awakenings will start at the onset of the DES and end within 10 seconds after the end of the DES or the after-discharge.). 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 26 May 2026.