The Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury

NCT06816199 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-02-10

No results posted yet for this study

Summary

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI).

The main question it aims to answer are:

Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI, they will answer online or telephone survey questions about their functional independence for 2 years.

Conditions

Interventions

OTHER

Hyperbaric oxygen exposure

Between 1 week and 3 months after the traumatic brain injury, participants will receive hyperbaric oxygen therapy on a 2.0 ATA protocol for 60 minutes once a day, five times a week.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    collaborator OTHER
  • Fu Xing Hospital, Capital Medical University

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Zhihua Zhang · Departments of Physical Medithe Second Affiliated Hospital of Zhejiang University School of Medicine

  • Sujuan Li · Fu Xing Hospital, Capital Medical University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816199 on ClinicalTrials.gov