Disorders of ConsciousnessAI-HBOT-DoCNCT07855848
AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
A study testing AI-Assisted Personalized Hyperbaric Oxygen Therapy and Conventional Hyperbaric Oxygen Therapy in people with Disorders of Consciousness and Vegetative State, run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 1 site in China.
Trial summary
Disorders of consciousness (DoC) are severe neurological conditions characterized by impaired awareness and reduced interaction with the environment. Although hyperbaric oxygen therapy (HBOT) may promote neurological recovery, the optimal treatment strategy for individual patients remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorders of Consciousness, Vegetative State, Minimally Conscious State
- What is being tested?
- AI-Assisted Personalized Hyperbaric Oxygen Therapy and Conventional Hyperbaric Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 30 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS).
- Disease duration of at least 28 days after the onset of brain injury.
- Stable medical condition suitable for hyperbaric oxygen therapy.
- Baseline consciousness assessment available using the Coma Recovery Scale-Revised (CRS-R).
- Ability to undergo standardized hyperbaric oxygen therapy sessions and complete clinical follow-up.
- Written informed consent obtained from the legally authorized representative.
Who cannot join
- Contraindications to hyperbaric oxygen therapy, including untreated pneumothorax or other conditions considered unsafe for HBOT.
- Severe cardiovascular, respiratory, or systemic instability.
- Uncontrolled epilepsy or frequent seizures affecting assessment.
- Severe infection or metabolic disorders that may influence consciousness assessment.
- Previous participation in another interventional clinical trial that may affect neurological outcomes.
- Incomplete baseline clinical data or inability to complete follow-up assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaofeng Chen Shenzhen Baoxing Hospital contact
China1 site
Shenzhen Baoxing Hospital
Shenzhen, Guangdong, 518020
Xiaofeng Chen Shenzhen Baoxing Hospital, 0755-28746265, us@szus.org
About this study
Official title: A Randomized Controlled Trial of Artificial Intelligence-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback in Patients With Disorders of Consciousness
Disorders of consciousness (DoC) are severe neurological conditions characterized by impaired awareness and reduced interaction with the environment. Although hyperbaric oxygen therapy (HBOT) may promote neurological recovery, the optimal treatment strategy for individual patients remains unclear.
This study aims to develop and validate an artificial intelligence-assisted precision decision support system for HBOT based on dynamic BIS-EEG brain functional feedback. The system will integrate clinical information, neuroimaging data, physiological parameters, consciousness assessments, and HBOT treatment characteristics.
Read more
Continuous BIS-EEG monitoring will be performed during different phases of HBOT, including compression, oxygen exposure, air breaks, decompression, and post-treatment recovery. Artificial intelligence models will analyze these dynamic brain functional responses to predict treatment effectiveness and support personalized HBOT management.
The primary outcome will be improvement in consciousness assessed by the Coma Recovery Scale-Revised (CRS-R). Secondary outcomes include changes in consciousness state, cognitive and functional recovery, and treatment-related adverse events.
Read the detailed description
This prospective randomized controlled clinical study will evaluate whether an artificial intelligence-assisted precision hyperbaric oxygen therapy strategy improves clinical outcomes compared with conventional hyperbaric oxygen therapy in patients with disorders of consciousness.
Patients with disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome and minimally conscious state, will receive standardized hyperbaric oxygen therapy. Multimodal clinical data will be collected, including demographic characteristics, disease etiology, disease duration, baseline consciousness assessment, neuroimaging findings, physiological parameters, BIS-EEG signals, and HBOT treatment parameters.
Dynamic BIS-EEG monitoring will be conducted throughout the entire HBOT session. Brain functional responses will be evaluated during the following phases: pre-treatment baseline, compression, hyperbaric oxygen exposure, air-break interval, repeated oxygen exposure, decompression, and post-treatment recovery.
The artificial intelligence system will integrate multimodal information using machine learning approaches to identify predictive biomarkers of neurological recovery and provide individualized decision support regarding HBOT treatment parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course.
The effectiveness of the AI-assisted decision support system will be evaluated by comparing predicted treatment responses with clinical outcomes. Clinical outcomes will include changes in Coma Recovery Scale-Revised (CRS-R) scores, consciousness state transitions, cognitive and functional recovery, and adverse events associated with HBOT.
This study is expected to provide an objective and personalized approach for optimizing HBOT management in patients with disorders of consciousness.
- Being tested
- AI-Assisted Personalized Hyperbaric Oxygen Therapy, Conventional Hyperbaric Oxygen Therapy
- Keywords
- Hyperbaric Oxygen Therapy, BIS-EEG, Artificial Intelligence, Brain Functional Feedback, Precision Medicine, Clinical Decision Support System
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Personalized Hyperbaric Oxygen TherapyOther
Participants will receive hyperbaric oxygen therapy optimized by an artificial intelligence-assisted clinical decision support system. The system integrates dynamic BIS-EEG brain functional feedback, clinical characteristics, neuroimaging findings, physiological parameters, and previous treatment responses to provide individualized recommendations for hyperbaric oxygen therapy parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course. Final treatment decisions will be made by qualified physicians.
Conventional Hyperbaric Oxygen TherapyOther
Participants will receive conventional hyperbaric oxygen therapy according to standard clinical protocols determined by treating physicians. Treatment parameters will be selected based on routine clinical practice without artificial intelligence-assisted recommendations.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Personalized Hyperbaric Oxygen Therapy | Experimental | Participants will receive artificial intelligence-assisted precision hyperbaric oxygen therapy. The AI decision support system will integrate dynamic BIS-EEG brain functional feedback, clinical characteristics, neuroimaging findings, physiological parameters, and previous treatment responses to provide individualized recommendations for hyperbaric oxygen therapy parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course. Receives: Other: AI-Assisted Personalized Hyperbaric Oxygen Therapy |
| Conventional Hyperbaric Oxygen Therapy | Active comparator | Participants will receive conventional hyperbaric oxygen therapy according to standard clinical protocols determined by treating physicians. Treatment parameters will be selected based on routine clinical practice without artificial intelligence-assisted recommendations. Receives: Other: Conventional Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Coma Recovery Scale-Revised (CRS-R) Total Score at Week 12
The Coma Recovery Scale-Revised (CRS-R) will be used to assess the level of consciousness. The CRS-R total score ranges from 0 to 23, with higher scores indicating better neurobehavioral function and a higher level of consciousness. The change in CRS-R total score from baseline to Week 12 will be calculated for each participant and compared between the AI-assisted precision hyperbaric oxygen therapy group and the conventional hyperbaric oxygen therapy group.
Measured: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
Secondary outcomes (2)
Change From Baseline in Glasgow Coma Scale (GCS) Total Score at Week 12
The Glasgow Coma Scale (GCS) will be used to assess neurological responsiveness. The total score ranges from 3 to 15, with higher scores indicating better neurological responsiveness. Change from baseline to Week 12 will be compared between the AI-assisted precision hyperbaric oxygen therapy group and the conventional hyperbaric oxygen therapy group.
Measured: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
Number of Participants With Hyperbaric Oxygen Therapy-Related Adverse Events
The number and proportion of participants experiencing adverse events considered related to hyperbaric oxygen therapy will be recorded and compared between groups. Events of interest include middle-ear or sinus barotrauma, oxygen toxicity, seizures, pulmonary symptoms, hemodynamic instability, and other clinically significant treatment-related adverse events.
Measured: From the first hyperbaric oxygen therapy session through 7 days after the final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to two parallel groups. The experimental group will receive artificial intelligence-assisted personalized hyperbaric oxygen therapy based on dynamic BIS-EEG brain functional feedback. The control group will receive conventional hyperbaric oxygen therapy according to standard clinical protocols. Clinical outcomes will be compared between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855848
- Sponsor's protocol ID
- WINDO-CT-26001
- Acronym
- AI-HBOT-DoC
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Artificial Intelligence-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT07855848
- Acronym / sponsor ID
- AI-HBOT-DoC / WINDO-CT-26001
- Keywords
- Hyperbaric Oxygen Therapy, BIS-EEG, Artificial Intelligence, Brain Functional Feedback, Precision Medicine, Clinical Decision Support System
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Oct 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.
Disorders of consciousness (DoC) are severe neurological conditions characterized by impaired awareness and reduced interaction with the environment. Although hyperbaric oxygen therapy (HBOT) may promote neurological recovery, the optimal treatment strategy for individual patients remains unclear.
This study aims to develop and validate an artificial intelligence-assisted precision decision support system for HBOT based on dynamic BIS-EEG brain functional feedback. The system will integrate clinical information, neuroimaging data, physiological parameters, consciousness assessments, and HBOT treatment characteristics.
Continuous BIS-EEG monitoring will be performed during different phases of HBOT, including compression, oxygen exposure, air breaks, decompression, and post-treatment recovery. Artificial intelligence models will analyze these dynamic brain functional responses to predict treatment effectiveness and support personalized HBOT management.
The primary outcome will be improvement in consciousness assessed by the Coma Recovery Scale-Revised (CRS-R). Secondary outcomes include changes in consciousness state, cognitive and functional recovery, and treatment-related adverse events.
Detailed description
This prospective randomized controlled clinical study will evaluate whether an artificial intelligence-assisted precision hyperbaric oxygen therapy strategy improves clinical outcomes compared with conventional hyperbaric oxygen therapy in patients with disorders of consciousness.
Patients with disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome and minimally conscious state, will receive standardized hyperbaric oxygen therapy. Multimodal clinical data will be collected, including demographic characteristics, disease etiology, disease duration, baseline consciousness assessment, neuroimaging findings, physiological parameters, BIS-EEG signals, and HBOT treatment parameters.
Dynamic BIS-EEG monitoring will be conducted throughout the entire HBOT session. Brain functional responses will be evaluated during the following phases: pre-treatment baseline, compression, hyperbaric oxygen exposure, air-break interval, repeated oxygen exposure, decompression, and post-treatment recovery.
The artificial intelligence system will integrate multimodal information using machine learning approaches to identify predictive biomarkers of neurological recovery and provide individualized decision support regarding HBOT treatment parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course.
The effectiveness of the AI-assisted decision support system will be evaluated by comparing predicted treatment responses with clinical outcomes. Clinical outcomes will include changes in Coma Recovery Scale-Revised (CRS-R) scores, consciousness state transitions, cognitive and functional recovery, and adverse events associated with HBOT.
This study is expected to provide an objective and personalized approach for optimizing HBOT management in patients with disorders of consciousness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to two parallel groups. The experimental group will receive artificial intelligence-assisted personalized hyperbaric oxygen therapy based on dynamic BIS-EEG brain functional feedback. The control group will receive conventional hyperbaric oxygen therapy according to standard clinical protocols. Clinical outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Personalized Hyperbaric Oxygen Therapy | Experimental | Other: AI-Assisted Personalized Hyperbaric Oxygen TherapyParticipants will receive artificial intelligence-assisted precision hyperbaric oxygen therapy. The AI decision support system will integrate dynamic BIS-EEG brain functional feedback, clinical characteristics, neuroimaging findings, physiological parameters, and previous treatment responses to provide individualized recommendations for hyperbaric oxygen therapy parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course. |
| Conventional Hyperbaric Oxygen Therapy | Active comparator | Other: Conventional Hyperbaric Oxygen TherapyParticipants will receive conventional hyperbaric oxygen therapy according to standard clinical protocols determined by treating physicians. Treatment parameters will be selected based on routine clinical practice without artificial intelligence-assisted recommendations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Diagnosis of disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS).
- Disease duration of at least 28 days after the onset of brain injury.
- Stable medical condition suitable for hyperbaric oxygen therapy.
- Baseline consciousness assessment available using the Coma Recovery Scale-Revised (CRS-R).
Key exclusion criteria (6 listed)
- Contraindications to hyperbaric oxygen therapy, including untreated pneumothorax or other conditions considered unsafe for HBOT.
- Severe cardiovascular, respiratory, or systemic instability.
- Uncontrolled epilepsy or frequent seizures affecting assessment.
- Severe infection or metabolic disorders that may influence consciousness assessment.
- Previous participation in another interventional clinical trial that may affect neurological outcomes.
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 |
|---|---|---|
| AI-Assisted Personalized Hyperbaric Oxygen TherapyParticipants will receive hyperbaric oxygen therapy optimized by an artificial intelligence-assisted clinical decision support system. The system integrates dynamic BIS-EEG brain functional feedback, clinical characteristics, neuroimaging findings, physiological parameters, and previous treatment responses to provide individualized recommendations for hyperbaric oxygen therapy parameters, including treatment pressure, oxygen exposure duration, air-break strategy, treatment frequency, and treatment course. Final treatment decisions will be made by qualified physicians. | Other | AI-Assisted Personalized Hyperbaric Oxygen Therapy |
| Conventional Hyperbaric Oxygen TherapyParticipants will receive conventional hyperbaric oxygen therapy according to standard clinical protocols determined by treating physicians. Treatment parameters will be selected based on routine clinical practice without artificial intelligence-assisted recommendations. | Other | Conventional Hyperbaric Oxygen Therapy |
Primary outcome
Change From Baseline in Coma Recovery Scale-Revised (CRS-R) Total Score at Week 12
Time frame: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
The Coma Recovery Scale-Revised (CRS-R) will be used to assess the level of consciousness. The CRS-R total score ranges from 0 to 23, with higher scores indicating better neurobehavioral function and a higher level of consciousness. The change in CRS-R total score from baseline to Week 12 will be calculated for each participant and compared between the AI-assisted precision hyperbaric oxygen therapy group and the conventional hyperbaric oxygen therapy group.
2 secondary outcomes
Change From Baseline in Glasgow Coma Scale (GCS) Total Score at Week 12
Time frame: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy
Number of Participants With Hyperbaric Oxygen Therapy-Related Adverse Events
Time frame: From the first hyperbaric oxygen therapy session through 7 days after the final treatment session
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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaofeng Chen Shenzhen Baoxing Hospital contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Personalized Hyperbaric Oxygen Therapy and Conventional Hyperbaric Oxygen Therapy in people with Disorders of Consciousness and Vegetative State, run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 1 site in China.
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 6 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 2 Oct 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 China. 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 Anmin Hu Shenzhen United Scheme Technology Co., Ltd. (+86 17318061949, anmin@szus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Coma Recovery Scale-Revised (CRS-R) Total Score at Week 12 (time frame: Baseline and 12 weeks after initiation of hyperbaric oxygen therapy). 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 2 Oct 2026.