Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

28 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Anmin Hu Shenzhen United Scheme Technology Co., Ltd.
  • Telefoonnummer: +86 17318061949
  • E-mail: anmin@szus.org

Studie Contact Back-up

  • Naam: Xiaofeng Chen Shenzhen Baoxing Hospital

Studie Locaties

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen Baoxing Hospital
        • Contact:
          • Xiaofeng Chen Shenzhen Baoxing Hospital
          • Telefoonnummer: 0755-28746265
          • E-mail: us@szus.org

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Actieve vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Coma Recovery Scale-Revised (CRS-R) Total Score at Week 12
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Glasgow Coma Scale (GCS) Total Score at Week 12
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Discrimination Performance of the AI Model for Predicting Improvement in Consciousness State
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

28 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 september 2026

Eerst geplaatst (Werkelijk)

2 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WINDO-CT-26001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren