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Brain scans may unlock why some epilepsy patients stop breathing during sleep

NCT ID NCT07249034

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study uses brain scans to see how epilepsy changes a brain chemical called adenosine in areas that control breathing and wakefulness. Researchers will compare 50 people with drug-resistant epilepsy to healthy volunteers. The goal is to better understand why some epilepsy patients may stop breathing during sleep, a condition linked to sudden unexpected death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal why some epilepsy patients are at risk of sudden death during sleep, pointing toward future prevention strategies.
What could go wrong
This is an early observational study with only 50 participants, so findings may not apply broadly. It aims to understand mechanisms, not test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For patients 1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study 2. Aged 18 to 55 years old 3. Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy 4. Diagnosis of refractory epilepsy, as defined by the International League Against Epilepsy as failure of adequate trials of two tolerated, appropriately chosen and used antiseizure drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom 5. Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) or generalized tonic-clonic seizure (GTCS) during the past 18 months 6. For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2) * For healthy volunteers 1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study 2. Aged 18 to 55 years old 3. For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2) Exclusion Criteria: * For patients 1. Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and/or patient treated by a pneumologist for respiratory insufficiency 2. Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and/or patient treated by a cardiologist for chronic heart failure 3. Ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist. 4. Obstructive sleep-apnea syndrome, defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not 5. Ongoing treatment with selective serotonin reuptake inhibitor (Selective Serotonin Reuptake Inhibitors): Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors): Duloxetine, Milnacipran, Venlafaxine 6. Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space-occupying lesion in the brain associated with brain oedema and/or mass effect on MRI/CT scan) 7. MRI contra-indication (presence of metallic elements, claustrophobia) 8. Patient treated with vagal nerve stimulation or deep brain stimulation 9. Pregnant women, women in labor or breastfeeding women, based on declarations at V0 10. Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures 11. Persons deprived of their liberty by a judicial or administrative decision 12. Adults subject to a legal protection measure (guardianship, curatorship) 13. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme 14. Positive urine pregnancy test at V2, if applicable 15. Hypersensitivity to \[18F\]-CPFPX * For healthy volunteers 1. History of epilepsy 2. Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and/or patient treated by a pneumologist for respiratory insufficiency 3. Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and/or patient treated by a cardiologist for chronic heart failure 4. Ischaemic heart disease defined as history of myocardial ischemia and/or of typical angina confirmed by a cardiologist. 5. Obstructive sleep-apnea syndrome, defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not 6. Ongoing treatment with selective serotonin reuptake inhibitor : SSRIs (Selective Serotonin Reuptake Inhibitors) : Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) : Duloxetine, Milnacipran, Venlafaxine 7. Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space-occupying lesion in the brain associated with brain oedema and/or mass effect on MRI/CT scan) 8. MRI contra-indication (presence of metallic elements, claustrophobia) 9. Pregnant women, women in labor or breastfeeding women, based on declarations at V0 10. Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures 11. Persons deprived of their liberty by a judicial or administrative decision 12. Adults subject to a legal protection measure (guardianship, curatorship) 13. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme 14. Positive urine pregnancy test at V2, if applicable 15. Hypersensitivity to \[18F\]-CPFPX

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Hospices Civils de Lyon

    Bron, 69500, France

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Other studies related to the condition(s) this trial covers.