SuicidePhase 4SIPHONNCT07461272
Self-hangIng Patient and Hyperbaric Oxygen Therapy _ SIPHON Study
A Phase 4 study testing OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL in people with Suicide, run by University Hospital, Lille.
Trial summary
During an attempted hanging, patients present severe neurological distress that can lead to major neuropsychiatric sequelae. These sequelae are notably due to significant cerebral edema related to hanging. Hyperbaric Oxygen therapy is known to reduce cerebral edema and improve cerebral perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present, following an attempted hanging, neurological distress defined by the presence of one or more of the following criteria:
- Glasgow score < 13/15
- Confusional syndrome
- Psychomotor agitation Who most of the time require optimal neuroprotection by sedation and invasive mechanical ventilation for the purpose of protecting the airways.
- Patient aged over 18 years,
- Suicide attempt by hanging without cardiocirculatory arrest,
- Patient insured socially and able to understand the information provided
Who cannot join
- Response time exceeded by > 6 hours from the hanging
- Attempted hanging with immediate return to normal consciousness
- Refusal of consent from the family or trusted person at the time of inclusion in the study,
- Patients and/or families unable to understand the information provided
About this study
Official title: Self-hangIng Patient and Hyperbaric Oxygen Therapy - SIPHON Study / Place de l'Oxygénothérapie Hyperbare Dans la Prise en Charge Des Tentatives de Pendaison
During an attempted hanging, patients present severe neurological distress that can lead to major neuropsychiatric sequelae. These sequelae are notably due to significant cerebral edema related to hanging. Hyperbaric Oxygen therapy is known to reduce cerebral edema and improve cerebral perfusion. The main objective of the study is to evaluate in patients who have attempted hanging without presenting cardio-respiratory arrest, the effect of one Hyperbaric Oxygen therapy session in addition to standard intensive care management on a potential reduction in short-term neurological sequelae. Patients will benefit from either standard management or standard management associated with one Hyperbaric Oxygen therapy session
- Conditions
- Suicide
- Being tested
- OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL
- Keywords
- Hanging, Neurological sequelae, Hyperbaric oxygen therapy, Intensive care
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICALDrug
In addition to standard intensive care management, patients will receive a hyperbaric oxygen therapy session within eight hours of admission to intensive care (the hyperbaric oxygen therapy session lasts two hours and must be completed eight hours after the hanging attempt).
| Study group | Role | What they receive |
|---|---|---|
| - Oxygèn | Experimental | Patients will receive standard intensive care management and an oxygen therapy session within 8 hours Receives: Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL |
| - Control group | No intervention | Patients will receive standard intensive care management only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Score
The score can be interpreted as follows:
≥ 26/30 = no neurocognitive impairment 18-25/30 = mild impairment 10-17 = moderate impairment Less than 10 = severe impairment
Measured: 72 hours plus or minus 6 hours
Secondary outcomes (4)
Montreal Cognitive Assessment Score
The score can be interpreted as follows:
≥ 26/30 = no neurocognitive impairment 18-25/30 = mild impairment 10-17 = moderate impairment Less than 10 = severe impairment
Measured: Montreal Cognitive Assessment Score at 6 months
Duration of mechanical ventilation
Measured: Participants will be monitored for duration of mechanical ventilation Participants will be monitored for duration of mechanical ventilation, an expected average of 24 hours
Duration of hospital stay
Measured: Participants will be monitored for duration of hospital stay, an expected average of 4 days.
Number of adverse events
Measured: Number of adverse effects during hospitalization, an expected average of 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461272
- Sponsor's protocol ID
- 2025/0204
- Acronym
- SIPHON
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 22 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-hangIng Patient and Hyperbaric Oxygen Therapy - SIPHON Study / Place de l'Oxygénothérapie Hyperbare Dans la Prise en Charge Des Tentatives de Pendaison
- ClinicalTrials.gov ID
- NCT07461272
- Acronym / sponsor ID
- SIPHON / 2025/0204
- Conditions
- Suicide
- Keywords
- Hanging, Neurological sequelae, Hyperbaric oxygen therapy, Intensive care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Mar 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.
During an attempted hanging, patients present severe neurological distress that can lead to major neuropsychiatric sequelae. These sequelae are notably due to significant cerebral edema related to hanging. Hyperbaric Oxygen therapy is known to reduce cerebral edema and improve cerebral perfusion. The main objective of the study is to evaluate in patients who have attempted hanging without presenting cardio-respiratory arrest, the effect of one Hyperbaric Oxygen therapy session in addition to standard intensive care management on a potential reduction in short-term neurological sequelae. Patients will benefit from either standard management or standard management associated with one Hyperbaric Oxygen therapy session
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| - Oxygèn | Experimental | Drug: OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICALPatients will receive standard intensive care management and an oxygen therapy session within 8 hours |
| - Control group | No intervention | –Patients will receive standard intensive care management only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who present, following an attempted hanging, neurological distress defined by the presence of one or more of the following criteria:
- Glasgow score < 13/15
- Confusional syndrome
- Psychomotor agitation Who most of the time require optimal neuroprotection by sedation and invasive mechanical ventilation for the purpose of protecting the airways.
- Patient aged over 18 years,
Key exclusion criteria (4 listed)
- Response time exceeded by > 6 hours from the hanging
- Attempted hanging with immediate return to normal consciousness
- Refusal of consent from the family or trusted person at the time of inclusion in the study,
- Patients and/or families unable to understand the information provided
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 |
|---|---|---|
| OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICALIn addition to standard intensive care management, patients will receive a hyperbaric oxygen therapy session within eight hours of admission to intensive care (the hyperbaric oxygen therapy session lasts two hours and must be completed eight hours after the hanging attempt). | Drug | - Oxygèn |
Primary outcome
Montreal Cognitive Assessment Score
Time frame: 72 hours plus or minus 6 hours
The score can be interpreted as follows: ≥ 26/30 = no neurocognitive impairment 18-25/30 = mild impairment 10-17 = moderate impairment Less than 10 = severe impairment
4 secondary outcomes
Montreal Cognitive Assessment Score
Time frame: Montreal Cognitive Assessment Score at 6 months
Duration of mechanical ventilation
Time frame: Participants will be monitored for duration of mechanical ventilation Participants will be monitored for duration of mechanical ventilation, an expected average of 24 hours
Duration of hospital stay
Time frame: Participants will be monitored for duration of hospital stay, an expected average of 4 days.
Number of adverse events
Time frame: Number of adverse effects during hospitalization, an expected average of 4 days.
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 22 May 2026.
Related trials for Suicide
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OXYGENE MEDICINAL LIQUIDE AIR PRODUCTS MEDICAL in people with Suicide, run by University Hospital, Lille.
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 4 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Montreal Cognitive Assessment Score (time frame: 72 hours plus or minus 6 hours). 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 22 May 2026.