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

NCT07855848 | Not Yet Recruiting

• 1 other identifier: WINDO-CT-26001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Disorders of Consciousness; Vegetative State; Minimally Conscious State

Keywords

Hyperbaric Oxygen Therapy; BIS-EEG; Artificial Intelligence; Brain Functional Feedback; Precision Medicine; Clinical Decision Support System

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline and 12 weeks after initiation of hyperbaric oxygen therapy

• Number of Participants With Hyperbaric Oxygen Therapy-Related Adverse Events

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

Other Outcomes (1)

• Discrimination Performance of the AI Model for Predicting Improvement in Consciousness State

  Prediction at baseline and during treatment for clinical outcome assessed at Week 12

Study Arms (2)

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.

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.

Other: Conventional Hyperbaric Oxygen Therapy

Interventions

AI-Assisted Personalized Hyperbaric Oxygen Therapy OTHER

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.

AI-Assisted Personalized Hyperbaric Oxygen Therapy

Conventional Hyperbaric Oxygen Therapy OTHER

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.

Conventional Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.: lead

Study Sites (1)

Shenzhen Baoxing Hospital

Shenzhen, Guangdong, 518020, China

Location

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Central Study Contacts

Anmin Hu Shenzhen United Scheme Technology Co., Ltd.

CONTACT

+86 17318061949; anmin@szus.org

Xiaofeng Chen Shenzhen Baoxing Hospital

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (1)