HBOT Clinical Trials Tracker

Foundational Trials by Indication

Neurological HBOT (TBI, Stroke, Long COVID)

Wound Care & UHMS-Approved Indications

Emergency HBOT (DCS, CO, Gas Gangrene)

The emergency HBOT indications have the longest clinical history and the strongest evidence base from retrospective analyses of large case series, military data, and the few RCTs that have been feasible:

• Decompression sickness — No modern RCT (ethically infeasible given life-threatening presentation). US Navy Treatment Table 6 (established 1960s, refined through the 1970s and 1980s) is the standard of care based on hundreds of thousands of treated cases.
• Carbon monoxide poisoning — Weaver 2002 NEJM remains the methodologically strongest trial. Three subsequent trials (Scheinkestel 1999, Thom 1995, Raphael 1989) produced mixed results, variously attributed to differences in CO severity criteria, treatment timing, and protocol specifications.
• Clostridial myonecrosis — No RCT; retrospective case series support HBOT as adjunct to surgical debridement and penicillin.
• Necrotising soft-tissue infection — Retrospective studies (Wilkinson 2004, Riseman 1990) suggest mortality benefit when HBOT added to surgical and antibiotic management.

Active & Recruiting Trials (2025–2026)

For the current, authoritative list of active HBOT clinical trials, search ClinicalTrials.gov. Major current programmes include:

• Long COVID / PASC — Multiple Phase 2/3 trials across the Efrati Lab (Tel Aviv), Mayo Clinic, Harvard-affiliated centres, and EU academic hospitals. Several using 2.0 ATA / 40-session courses to replicate Zilberman-Itskovich 2022.
• Post-acute mild TBI — Ongoing US Department of Defense and VA-funded trials in military and veteran populations. Includes studies examining response predictors and optimal course length.
• Age-related cognitive decline / "healthy ageing" — Efrati-lab affiliated programmes studying 2.0 ATA protocols in asymptomatic older adults. The HBOT-mediated telomere findings (Hachmo 2020) have spawned follow-up longevity trials.
• Diabetic ulcer prevention & healing acceleration — Phase 3 confirmatory trials across US and EU wound-care networks. Also novel protocols combining HBOT with growth factor topical therapies.
• Alzheimer's disease (early stage) — Early investigator-initiated trials following animal-model evidence of HBOT effects on amyloid clearance and neuroinflammation.
• Lyme disease, chronic fatigue syndrome — Investigator-initiated Phase 2 trials; early-stage research.
• Pre- and post-cardiac surgery — Trials evaluating HBOT for post-operative cognitive dysfunction and cardiac remodelling.

How HBOT Trials Are Designed

Pressure & FiO₂ Specification

Every trial specifies the chamber pressure (in ATA or ATG) and the inspired oxygen fraction. Clinical HBOT typically uses 100% O₂ at 2.0 ATA or higher. "Mild HBOT" trials use 1.3 ATA with ambient air plus concentrator oxygen (85–95%). These produce substantially different arterial oxygen tensions and must be interpreted as different interventions.

Session Length & Air Breaks

Standard sessions run 60–120 minutes. At 2.0 ATA and above, protocols typically include 5-minute "air breaks" every 20–30 minutes to reduce CNS oxygen toxicity risk. Trial protocols should specify total O₂ time (not just total session time).

Course Length

Course length varies by indication:

• Emergency (DCS, CO, gas gangrene) — 1–5 sessions, typically within 24 hours of presentation.
• Wound care — 20–40 sessions over 4–8 weeks, with interim assessment every 10 sessions.
• Neurological protocols — 40–60 sessions over 8–12 weeks (five days per week).

Sham Design

Blinding HBOT is challenging. True "no treatment" sham is immediately detectable (no pressurisation sensation). Common approaches:

• Low-pressure sham (1.1–1.2 ATA with air) — produces compression sensations but minimal biological effect. Used in most Efrati-lab trials.
• Alternating pressure — brief compression to 1.3 ATA then release.
• Open-label pragmatic trials — no sham; useful for effectiveness research but prone to placebo contamination.

Interpretation note: the sham pressure matters. If the sham arm itself produces biological activity (e.g. 1.3 ATA sham in an autism trial), the apparent effect of the active arm is narrowed.

Outcome Measures

• Objective: neurocognitive batteries (ANAM, CNS Vital Signs, specific tests for domain of interest), neuroimaging (SPECT, perfusion MRI, DTI for TBI), transcutaneous oxygen (TcPO₂) for wound healing, wound size and healing time, mortality (CO, DCS).
• Subjective: symptom questionnaires (SF-36 quality of life, condition-specific scales), patient-reported outcomes.
• Mechanistic/biomarker: stem cell mobilisation (CD34+), inflammatory cytokines, telomere length, oxidative stress markers.

Follow-up Window

Neurological HBOT trials ideally include follow-up assessments 1–3 months post-course, as benefit often continues to accumulate during the post-treatment neuroplasticity window. End-of-course-only designs may underestimate durable benefit.

Enrolment Patterns (What Patients Should Expect)

Typical Inclusion Criteria

• Confirmed diagnosis of the indication under study
• Age range (often 18–80, varies by trial)
• Medical stability (able to tolerate 60–90 minute pressurisation sessions)
• Able to equalise middle ear pressure or willing to undergo myringotomy if needed
• Symptoms persisting beyond acute phase for neurological indications

Typical Exclusion Criteria

• Untreated pneumothorax
• Severe COPD with air trapping or bullae
• Active chemotherapy with bleomycin or doxorubicin
• Uncontrolled epilepsy (seizure risk at pressure)
• Severe claustrophobia unresponsive to anxiolysis
• Pregnancy (except emergency indications like CO)
• Recent eye surgery
• Significant cognitive impairment preventing informed consent

Finding a Trial

• ClinicalTrials.gov — US-centric but also includes international trials. Search "hyperbaric oxygen" plus your indication.
• ISRCTN registry — International registry including many UK/EU trials.
• ANZCTR — Australia and New Zealand clinical trials registry.
• Hyperbaric facility websites — Many Efrati-affiliated centres and university hyperbaric programmes list their active trials directly.

Research disclaimer: This tracker is a reference only. Enrolment in a clinical trial should be discussed with a qualified physician and the trial's investigators. Trial inclusion/exclusion criteria vary significantly between studies and across time.