EpilepsyCARROUSELNCT06545214
Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy
A study testing Video-EEG monitoring, Respiratory monitoring and polysomnography and 1 Hypercapnic challenge while participant is awake in people with Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, from cognitive dysfunctions to premature mortality. Both seizures and their complications are modulated by patients' vigilance states, with a tight and bi-directional interplay between sleep and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Video-EEG monitoring, Respiratory monitoring and polysomnography and 1 Hypercapnic challenge while participant is awake
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2024to 4 Jan 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients :
- 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 epilepsy
- Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy
- Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) during the past 18 months
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- Patients who had undergone long-term video-EEG (VEEG) monitoring for presurgical evaluation in the past ten years within the Department of Functional Neurology and Epileptology at Hospices Civils de Lyon, ensuring access to detailed information about:
- occurrence of transient respiratory dysfunction during the focal seizures, transient hypoxemia during strictly focal seizures being observed in 40% of patients(39) and in 87% of patients with at least one FBTCS during the VEEG monitoring(46)
- localization of the epileptogenic zone, the risk of peri-ictal respiratory dysfunction being greater in seizures of temporal lobe origin than in extra-temporal seizures, even after FBTCS
- Healthy subjects
- 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
Who cannot join
- Patients
- Ongoing or chronic respiratory and/or cardiac insufficiency
- Obstructive sleep-apnea syndrome
- Ongoing treatment with selective serotonin reuptake inhibitor
- Patient treated with vagal nerve stimulation
- Pregnant women or breastfeeding women, based on declarations at V0
Show all 21Show fewer
- Persons receiving psychiatric care
- 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
- Positive urine pregnancy test at V1, if applicable
- Healthy subjects
- History of epilepsy
- Ongoing or chronic respiratory and/or cardiac insufficiency
- Obstructive sleep-apnea syndrome
- Pregnant women, women in labor or breastfeeding women, based on declarations at V0
- Persons receiving psychiatric care
- 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
- Positive urine pregnancy test at V1, if applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pierre Wertheimer
Bron, Rhone, 69500
Sylvain Rheims, PR, 0472357106 ext. +33, sylvain.rheims@chu-lyon.fr
About this study
30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, from cognitive dysfunctions to premature mortality. Both seizures and their complications are modulated by patients' vigilance states, with a tight and bi-directional interplay between sleep and epilepsy. Several epilepsy complications are associated with sleep, such as sleep-disordered breathing or Sudden and Unexpected Death in Epilepsy (SUDEP). SUDEP is a non-traumatic death, unrelated to a documented status epilepticus, which accounts for up 50% of premature deaths in epilepsy, with a cumulative risk of ≈ 10% at 40 years in patients with childhood-onset epilepsy. SUDEP typically occurs during sleep, after a nocturnal seizure, and primarily results from a postictal central respiratory dysfunction in patients with generalized convulsive seizure (GCS), suggesting that interaction between respiratory dysfunction and sleep state may play a role in its pathophysiology.
Most of patients with drug-resistant seizures demonstrate transient peri-ictal apnea and hypoxemia, especially in the aftermath of a GCS. Experimental and clinical data suggest that most SUDEP primarily result from a fatal seizure-related respiratory arrest. In patients whose SUDEP had occurred during long-term video-EEG monitoring, we observed fatal postictal central apnea after a nocturnal GCS in all SUDEP. Accordingly, it is currently hypothesized that in a subgroup of patients, repetition of seizures may contribute to chronic alteration of respiratory regulation which may increase the risk of fatal postictal central respiratory arrest. Finally, post-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla.
The complex network that regulates arousal and sleep and the respiratory network are strongly interconnected. Impairment of the interaction between central respiratory control and arousal systems has been reported in several clinical situations, including sleep apnea syndrome, sudden infant death syndrome or Prader-Willi Syndrome. In epilepsy, preclinical data in rodents indirectly support a role for 5HT in the impairment of the interactions between the arousal and respiratory systems in the cascade of events leading to SUDEP. However, no direct evidence is available, and the link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet.
- Conditions
- Epilepsy
- Being tested
- Video-EEG monitoring, Respiratory monitoring and polysomnography, 1 Hypercapnic challenge while participant is awake, 2 Hypercapnic challenges while participant is sleeping, Auditory stimulus
- Keywords
- Epilepsy, SUDEP, GTCS, Drug-resistant, Arousal, Hypercanic challenge
- Medical subject headings
- Epilepsy, Sudden Unexpected Death in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-EEG monitoringProcedure or surgery
Video-EEG monitoring
Respiratory monitoring and polysomnographyProcedure or surgery
heart rate, pulse oximetry (oxygen levels in the blood), nasal airflow, respiratory effort (thoracic and abdominal) and capnography (carbon dioxide (CO2) levels in exhaled air)
1 Hypercapnic challenge while participant is awakeProcedure or surgery
The healthy patient/subject breathes through the mouth, using a mouthpiece and a nose clip, through a device fitted with a hermetically sealed bag that measures the various parameters of his/her breathing. At the start of the test, the healthy patient/subject breathes ambient air and his or her breathing is measured. Then, after a few minutes, the healthy patient/subject is connected to the bag, breathing in a closed circuit. This causes a gradual increase in carbon dioxide (CO2) in the inspired air. During this time, breathing parameters will be measured and gas exchanges studied with each breath. The test is stopped when the end-tidal carbon dioxide pressure (PetCO2) reaches 60 mm Hg, or in the event of intolerance.
2 Hypercapnic challenges while participant is sleepingProcedure or surgery
In the evening, as soon as the doctor detects on the EEG that the patient/subject is in deep sleep, various tests will be carried out to assess reactivity to wakefulness.
Two hypercapnic challenges will be carried out during sleep, using the same procedure as for wakefulness. The test will be stopped when the healthy patient/subject wakes up, or when the end-tidal carbon dioxide pressure (PetCO2) reaches 60 mm Hg, or in case of intolerance.
Auditory stimulusProcedure or surgery
Two auditory stimulus tests will be carried out during the patient's sleep. Using headphones, the investigator will administer auditory stimuli at regular, progressively louder intervals to determine the ability of the patient/ healthy subject to awaken to an auditory stimulus.
QuestionnairesOther
Questionnaire to assess caffeine consumption habits Quality of life questionnaires QOLIE-31 Anxiety and depression questionnaires HADS
| Study group | Role | What they receive |
|---|---|---|
| Patients with drug-resistant focal epilepsy | Other | Patients with >3 focal to bilateral tonic-clonic seizure per year and who had undergone long-term video-EEG (VEEG) monitoring for presurgical evaluation.
After a prospective baseline, which will allow to ensure prospective seizure count for patients with epilepsy, all participants will undergo a 24-hours hospitalization. The following procedures will be carried out as part of the research:
* Video-EEG recordings
* Respiratory monitoring
* Full-night polysomnography
* 1 Hypercapnic challenge while participant is awake
* 2 Hypercapnic challenges while participant is sleeping
* Auditory stimulus All the medical devices used in this study are already in routine use at Hospices Civils de Lyon Receives: Procedure: Video-EEG monitoring; Procedure: Respiratory monitoring and polysomnography; Procedure: 1 Hypercapnic challenge while participant is awake; Procedure: 2 Hypercapnic challenges while participant is sleeping; Procedure: Auditory stimulus; Other: Questionnaires |
| Healthy subjects | Other | Selection of healthy subjects will be performed to ensure age-matching.
After a prospective baseline, which will allow to ensure prospective seizure count for patients with epilepsy, all participants will undergo a 24-hours hospitalization. The following procedures will be carried out as part of the research:
* Video-EEG recordings
* Respiratory monitoring
* Full-night polysomnography
* 1 Hypercapnic challenge while participant is awake
* 2 Hypercapnic challenges while participant is sleeping
* Auditory stimulus All the medical devices used in this study are already in routine use at Hospices Civils de Lyon Receives: Procedure: Video-EEG monitoring; Procedure: Respiratory monitoring and polysomnography; Procedure: 1 Hypercapnic challenge while participant is awake; Procedure: 2 Hypercapnic challenges while participant is sleeping; Procedure: Auditory stimulus; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
End tidal CO2 (PETCO2) value at arousal in patients with epilepsy and in healthly subjects
PETCO2 corresponds to the value taken at the end of a breath of the partial pressure of CO2. Two hypercapnic challenges will be performed the same night. The first will start once unequivocal N3 stage of NREM will be observed, as determined online by polysomnography data. After the termination of the first test, the patient/subject will go back to sleep and a second procedure will be performed once she/he will reach N3 stage of NREM again. Data from the two procedures will be averaged for each subject.
Measured: the night of hospitalization
Secondary outcomes (8)
Value of the HCVR slope during sleep in patients with epilepsy and in healthy subjects
HCVR measures the increase in minute ventilation (VE) induced by an increase of PETCO2. The HCVR slope, expressed in L/min/mmHg, will be calculated from the linear regression of VE and PETCO2. Data from the two procedures per night described aboves will be averaged for each subject.
will be measured during hypercapnic sleep challenges during the night of hospitalization.
Measured: one night of hospitalization
Value of the awake HCVR slope in patients with epilepsy and in healthly subjects
As detailed in section 6.1.3, a hypercapnic challenge will be performed awake after arrival of the patient/subject in the epilepsy monitoring unit. Calculation of the awake HCVR slope wil be performed as described for HCVR slope during sleep
Measured: will be measured during hypercapnic challenges on awakening on the first day of hospitalization.
Value of the ventilatory recruitment threshold (VRT) in patients with epilepsy and in healthly subjects
VRT reflects the PCO2 value at which the central chemoreflex is initiated and corresponds to the onset of compensatory and progressive rise in VE during hypercapnic challenge. The determination of VRT requires a hyperventilation baseline period during which the measured VE is the one required to maintain hypopnea under resting metabolic conditions; termed basal ventilation or the "wakefulness drive" to drive. To determine VRT, it is therefore required that the subject breathes deeply for few minutes, raising her/his tidal volume such that she/he rapidly achieves and maintaines a PETCO2 of 20-25 mmHg. Then the hypercapnic challenge can be performed. In this context, VRT can not be determined during sleep.
Measured: will be measured during hypercapnic challenges on awakening on the first day of hospitalization.
Number of focal to bilateral tonic-clonic seizures during the 3 months preceding the polysomnography in patients with epilepsy
Measured: Will be collected during the first day of hospitalization
Central apnea index and Obstructive Apnea Hypopnea Index
Sleep apneas can classified as obstructive, central or both central sleep apnea, Apnea will be defined as a decrease in peak nasal pressure of >90% of baseline, lasting at least 10 s. Hypopnea was defined as a decrease of >30% of the baseline nasal pressure, lasting at least 10 s and associated with ≥4% drop in SpO2. Central apnea will be defined by cessation > 10 seconds of airflow with simultaneous cessation of respiratory effort. The respiratory events will be scored according to the 2007 American Academy of Sleep Medicine guidelines. Apnea index will correspond to total number of each apnea type divided by total sleep time over a 24-hour period.
Measured: one night of hospitalization
Sound intensity (dB) required to induced awakening
The paradigm will be the one proposed by Martin et al. 1996 ; Philip et al. 1994 . The stimulation will be manually delivered using earphone inserts and will consist in pure sounds of 1000Hz, from 40dB to 110dB, duration 5s. Stimulation starts after 5 min of unequivocal NREM, as assessed with continuous EEG montoring. The stimulation will start with intensity I1=50dB. If complete behavioral arousal (=awakening): stop stimulation and wait until 2 min of stable sleep (defined by re-apparition of a spindle, a K complex or REM) and next trial with I1-10dB. If arousal but no awakening: wait until 2 min of stable sleep and next trial with sound +10dB. If no Arousal : wait 10s and deliver sound +10dB or longer sound (10s)
Measured: one night of hospitalization
Current and past mean daily intake of caffeine (mg/day)
Current usual caffeine intake and the one over the last ten years will be assessed by a validated self-survey (Simonin et al., Neuroobiology of Disease 2013) filled-in at home by the patient and, if needed, the help of the caregiver filled between the inclusion visit and the polysomnography. Its reliability, assessed by retest (mean interval: 37.5 ± 5.5 days) in 31 patients, was excellent (intraclass correlation coefficient by Fleiss method: 0.97 [95% CI: 0.94-0.98]). The mean daily intake of caffeine containing items (coffee, tea, chocolate, sodas) will be reported, along with any changes of consumption over the 10 year period. All data will be then confirmed by interview perfomed during the stay in epilepsy monitoring unit.
Measured: Will be collected between inclusion and the first day of hospitalization
Presence of subjective experience of awakenings
Compare the subjective experience of awakenings induced by hypercapnic stimulations during sleep between healthy individuals and patients with drug-resistant epilepsy
Measured: one night of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Nov 2024
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric prospective non-randomized study comparing the arousal and respiratory responses to hypercapnia in adult patients with drug-resistant epilepsy and in healthy subjects
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06545214
- Sponsor's protocol ID
- 69HCL23_1350
- Acronym
- CARROUSEL
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2024
- Last updated
- 27 Mar 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy
- ClinicalTrials.gov ID
- NCT06545214
- Acronym / sponsor ID
- CARROUSEL / 69HCL23_1350
- Conditions
- Epilepsy
- Keywords
- Epilepsy, SUDEP, GTCS, Drug-resistant, Arousal, Hypercanic challenge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 9 Aug 2024 (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.
30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, from cognitive dysfunctions to premature mortality. Both seizures and their complications are modulated by patients' vigilance states, with a tight and bi-directional interplay between sleep and epilepsy. Several epilepsy complications are associated with sleep, such as sleep-disordered breathing or Sudden and Unexpected Death in Epilepsy (SUDEP). SUDEP is a non-traumatic death, unrelated to a documented status epilepticus, which accounts for up 50% of premature deaths in epilepsy, with a cumulative risk of ≈ 10% at 40 years in patients with childhood-onset epilepsy. SUDEP typically occurs during sleep, after a nocturnal seizure, and primarily results from a postictal central respiratory dysfunction in patients with generalized convulsive seizure (GCS), suggesting that interaction between respiratory dysfunction and sleep state may play a role in its pathophysiology.
Most of patients with drug-resistant seizures demonstrate transient peri-ictal apnea and hypoxemia, especially in the aftermath of a GCS. Experimental and clinical data suggest that most SUDEP primarily result from a fatal seizure-related respiratory arrest. In patients whose SUDEP had occurred during long-term video-EEG monitoring, we observed fatal postictal central apnea after a nocturnal GCS in all SUDEP. Accordingly, it is currently hypothesized that in a subgroup of patients, repetition of seizures may contribute to chronic alteration of respiratory regulation which may increase the risk of fatal postictal central respiratory arrest. Finally, post-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla.
The complex network that regulates arousal and sleep and the respiratory network are strongly interconnected. Impairment of the interaction between central respiratory control and arousal systems has been reported in several clinical situations, including sleep apnea syndrome, sudden infant death syndrome or Prader-Willi Syndrome. In epilepsy, preclinical data in rodents indirectly support a role for 5HT in the impairment of the interactions between the arousal and respiratory systems in the cascade of events leading to SUDEP. However, no direct evidence is available, and the link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric prospective non-randomized study comparing the arousal and respiratory responses to hypercapnia in adult patients with drug-resistant epilepsy and in healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Patients with drug-resistant focal epilepsy | Other | Procedure: Video-EEG monitoring, Procedure: Respiratory monitoring and polysomnography, Procedure: 1 Hypercapnic challenge while participant is awake, Procedure: 2 Hypercapnic challenges while participant is sleeping, Procedure: Auditory stimulus, Other: QuestionnairesPatients with >3 focal to bilateral tonic-clonic seizure per year and who had undergone long-term video-EEG (VEEG) monitoring for presurgical evaluation. After a prospective baseline, which will allow to ensure prospective seizure count for patients with epilepsy, all participants will undergo a 24-hours hospitalization. The following procedures will be carried out as part of the research: * Video-EEG recordings * Respiratory monitoring * Full-night polysomnography * 1 Hypercapnic challenge while participant is awake * 2 Hypercapnic challenges while participant is sleeping * Auditory stimulus All the medical devices used in this study are already in routine use at Hospices Civils de Lyon |
| Healthy subjects | Other | Procedure: Video-EEG monitoring, Procedure: Respiratory monitoring and polysomnography, Procedure: 1 Hypercapnic challenge while participant is awake, Procedure: 2 Hypercapnic challenges while participant is sleeping, Procedure: Auditory stimulus, Other: QuestionnairesSelection of healthy subjects will be performed to ensure age-matching. After a prospective baseline, which will allow to ensure prospective seizure count for patients with epilepsy, all participants will undergo a 24-hours hospitalization. The following procedures will be carried out as part of the research: * Video-EEG recordings * Respiratory monitoring * Full-night polysomnography * 1 Hypercapnic challenge while participant is awake * 2 Hypercapnic challenges while participant is sleeping * Auditory stimulus All the medical devices used in this study are already in routine use at Hospices Civils de Lyon |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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 epilepsy
- Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy
- Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) during the past 18 months
Key exclusion criteria (21 listed)
- Patients
- Ongoing or chronic respiratory and/or cardiac insufficiency
- Obstructive sleep-apnea syndrome
- Ongoing treatment with selective serotonin reuptake inhibitor
- Patient treated with vagal nerve stimulation
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 |
|---|---|---|
| Video-EEG monitoringVideo-EEG monitoring | Procedure or surgery | Healthy subjects, Patients with drug-resistant focal epilepsy |
| Respiratory monitoring and polysomnographyheart rate, pulse oximetry (oxygen levels in the blood), nasal airflow, respiratory effort (thoracic and abdominal) and capnography (carbon dioxide (CO2) levels in exhaled air) | Procedure or surgery | Healthy subjects, Patients with drug-resistant focal epilepsy |
| 1 Hypercapnic challenge while participant is awakeThe healthy patient/subject breathes through the mouth, using a mouthpiece and a nose clip, through a device fitted with a hermetically sealed bag that measures the various parameters of his/her breathing. At the start of the test, the healthy patient/subject breathes ambient air and his or her breathing is measured. Then, after a few minutes, the healthy patient/subject is connected to the bag, breathing in a closed circuit. This causes a gradual increase in carbon dioxide (CO2) in the inspired air. During this time, breathing parameters will be measured and gas exchanges studied with each breath. The test is stopped when the end-tidal carbon dioxide pressure (PetCO2) reaches 60 mm Hg, or in the event of intolerance. | Procedure or surgery | Healthy subjects, Patients with drug-resistant focal epilepsy |
| 2 Hypercapnic challenges while participant is sleepingIn the evening, as soon as the doctor detects on the EEG that the patient/subject is in deep sleep, various tests will be carried out to assess reactivity to wakefulness. Two hypercapnic challenges will be carried out during sleep, using the same procedure as for wakefulness. The test will be stopped when the healthy patient/subject wakes up, or when the end-tidal carbon dioxide pressure (PetCO2) reaches 60 mm Hg, or in case of intolerance. | Procedure or surgery | Healthy subjects, Patients with drug-resistant focal epilepsy |
| Auditory stimulusTwo auditory stimulus tests will be carried out during the patient's sleep. Using headphones, the investigator will administer auditory stimuli at regular, progressively louder intervals to determine the ability of the patient/ healthy subject to awaken to an auditory stimulus. | Procedure or surgery | Healthy subjects, Patients with drug-resistant focal epilepsy |
| QuestionnairesQuestionnaire to assess caffeine consumption habits Quality of life questionnaires QOLIE-31 Anxiety and depression questionnaires HADS | Other | Healthy subjects, Patients with drug-resistant focal epilepsy |
Primary outcome
End tidal CO2 (PETCO2) value at arousal in patients with epilepsy and in healthly subjects
Time frame: the night of hospitalization
PETCO2 corresponds to the value taken at the end of a breath of the partial pressure of CO2. Two hypercapnic challenges will be performed the same night. The first will start once unequivocal N3 stage of NREM will be observed, as determined online by polysomnography data. After the termination of the first test, the patient/subject will go back to sleep and a second procedure will be performed once she/he will reach N3 stage of NREM again. Data from the two procedures will be averaged for each subject.
8 secondary outcomes
Value of the HCVR slope during sleep in patients with epilepsy and in healthy subjects
Time frame: one night of hospitalization
Value of the awake HCVR slope in patients with epilepsy and in healthly subjects
Time frame: will be measured during hypercapnic challenges on awakening on the first day of hospitalization.
Value of the ventilatory recruitment threshold (VRT) in patients with epilepsy and in healthly subjects
Time frame: will be measured during hypercapnic challenges on awakening on the first day of hospitalization.
Number of focal to bilateral tonic-clonic seizures during the 3 months preceding the polysomnography in patients with epilepsy
Time frame: Will be collected during the first day of hospitalization
Central apnea index and Obstructive Apnea Hypopnea Index
Time frame: one night of hospitalization
Sound intensity (dB) required to induced awakening
Time frame: one night of hospitalization
Current and past mean daily intake of caffeine (mg/day)
Time frame: Will be collected between inclusion and the first day of hospitalization
Presence of subjective experience of awakenings
Time frame: one night of hospitalization
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 27 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-EEG monitoring, Respiratory monitoring and polysomnography and 1 Hypercapnic challenge while participant is awake in people with Epilepsy, run by Hospices Civils de Lyon 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 12 inclusion and 21 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 27 Mar 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?
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 Sylvain Pr Rheims (0472357106 ext. +33, sylvain.rheims@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End tidal CO2 (PETCO2) value at arousal in patients with epilepsy and in healthly subjects (time frame: the night of hospitalization). 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 27 Mar 2026.