AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness (AI-HBOT-DoC)

September 28, 2026 updated by: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Anmin Hu Shenzhen United Scheme Technology Co., Ltd.
  • Phone Number: +86 17318061949
  • Email: anmin@szus.org

Study Contact Backup

  • Name: Xiaofeng Chen Shenzhen Baoxing Hospital

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen Baoxing Hospital
        • Contact:
          • Xiaofeng Chen Shenzhen Baoxing Hospital
          • Phone Number: 0755-28746265
          • Email: us@szus.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults aged 18 years or older.
  2. Diagnosis of disorders of consciousness, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS).
  3. Disease duration of at least 28 days after the onset of brain injury.
  4. Stable medical condition suitable for hyperbaric oxygen therapy.
  5. Baseline consciousness assessment available using the Coma Recovery Scale-Revised (CRS-R).
  6. Ability to undergo standardized hyperbaric oxygen therapy sessions and complete clinical follow-up.
  7. Written informed consent obtained from the legally authorized representative.

Exclusion Criteria:

  1. Contraindications to hyperbaric oxygen therapy, including untreated pneumothorax or other conditions considered unsafe for HBOT.
  2. Severe cardiovascular, respiratory, or systemic instability.
  3. Uncontrolled epilepsy or frequent seizures affecting assessment.
  4. Severe infection or metabolic disorders that may influence consciousness assessment.
  5. Previous participation in another interventional clinical trial that may affect neurological outcomes.
  6. Incomplete baseline clinical data or inability to complete follow-up assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AI-Assisted Personalized Hyperbaric Oxygen Therapy

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.
Other: AI-Assisted Personalized Hyperbaric Oxygen Therapy

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.
Active Comparator: Conventional Hyperbaric Oxygen Therapy

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.
Other: Conventional Hyperbaric Oxygen Therapy

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks after initiation of hyperbaric oxygen therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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.
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

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.
From the first hyperbaric oxygen therapy session through 7 days after the final treatment session

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Discrimination Performance of the AI Model for Predicting Improvement in Consciousness State
Time Frame: Prediction at baseline and during treatment for clinical outcome assessed at Week 12

The predictive performance of the artificial intelligence model will be evaluated for predicting improvement to a higher consciousness state at Week 12. Discrimination will be assessed using the area under the receiver operating characteristic curve (AUROC). An AUROC of 0.5 indicates no discrimination, whereas values closer to 1.0 indicate better discrimination.
Prediction at baseline and during treatment for clinical outcome assessed at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WINDO-CT-26001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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