Hyperbaric oxygen for long COVID cognitive and fatigue symptoms
Hyperbaric Oxygen Therapy for Post-COVID-19 Syndrome: a Prospective, Randomized, Double Blind Study.
NA · Assaf-Harofeh Medical Center · NCT04647656
This trial will try hyperbaric oxygen therapy versus a sham treatment to see if it helps adults with long COVID who still have thinking problems, memory issues, fatigue, or other lingering symptoms at least three months after infection.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 91 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center (other gov) |
| Locations | 1 site (Ẕerifin) |
| Trial ID | NCT04647656 on ClinicalTrials.gov |
What this trial studies
Adults with persistent cognitive decline and other post-COVID symptoms for at least three months will be enrolled and receive either hyperbaric oxygen therapy (HBOT) or a sham procedure. Participants undergo multiple in-person HBOT or sham sessions and are followed with cognitive tests, symptom questionnaires, and brain MRI when possible. Key exclusion criteria include prior HBOT, traumatic brain injury or other non-COVID brain pathology, active malignancy, active smoking, and chest or ear conditions incompatible with pressure changes. The trial is conducted at Assaf-Harofeh Medical Center and requires attending scheduled clinic visits for treatment and assessments.
Who should consider this trial
Good fit: Adults (18+) with a confirmed prior COVID-19 infection who have ongoing cognitive problems that affect quality of life for at least three months and who can attend repeated in-person HBOT sessions are the intended participants.
Not a fit: Individuals with prior traumatic brain injury or other non-COVID brain disease, active cancer, active substance use or smoking, chest or ear conditions that prevent pressure changes, inability to undergo awake MRI, or who cannot attend repeated visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, HBOT could improve cognitive function, reduce fatigue, and help restore quality of life for people with long COVID.
How similar studies have performed: Some small case series and pilot reports suggest HBOT may improve cognitive and other symptoms after COVID-19 or brain injury, but robust randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age above 18 years 2. Reported post COVID-19 cognitive deterioration that effect quality of life and persist at least 3 months after confirmed infection. 3. Subject willing and able to read, understand and sign an informed consent Exclusion Criteria: 1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. History of traumatic brain injury (TBI) or any other non COVID brain pathology 3. Active malignancy 4. Substance use at baseline 5. Severe or unstable physical disorders or major cognitive deficits at baseline 6. HBOT for any reason prior to study enrolment 7. Chest pathology incompatible with pressure changes (including moderate to severe asthma) 8. Ear or Sinus pathology incompatible with pressure changes 9. An inability to perform an awake brain MRI 10. Active smoking
Where this trial is running
Ẕerifin
- Assaf-Harofeh medical center — Ẕerifin, Israel (RECRUITING)
Study contacts
- Principal investigator: Shai a Efrati, MD — Asaf-Harofhe MC
- Study coordinator: Shani Zilberman-Itskovich, Dr.
- Email: shani.zilberman@mail.huji.ac.il
- Phone: 97289979383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Covid19, Neurocognitive Dysfunction