Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04647656

Hyperbaric Oxygen Therapy for Post-COVID-19 Syndrome: a Prospective, Randomized, Double Blind Study.

Led by Assaf-Harofeh Medical Center · Updated on 2026-04-21

91

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Post-COVID-19 syndrome includes a range of symptoms such as cognitive impairment, fatigue, sleep disorders, and problems with smell and taste that can last for months after recovering from COVID-19. This condition affects many people worldwide and currently has no known treatment. Researchers are investigating the effects of hyperbaric oxygen therapy (HBOT) compared to a sham treatment to better understand potential benefits for this syndrome. The study involves two groups: one receiving HBOT and another receiving a sham treatment. The HBOT group will have 40 daily sessions, five days a week for two months, breathing 100% oxygen at a pressure of 2 atmospheres absolute (ATA) for 90 minutes with brief air breaks. The sham group will have sessions mimicking HBOT but with normal air and lower pressure to simulate the experience without delivering therapeutic oxygen levels. Participants will undergo various assessments including cognitive tests, brain imaging, symptom evaluation, quality of life and sleep questionnaires, pain inventories, neurological and physical evaluations, and cardiopulmonary tests at the start and after two months. Some measures will continue at one year to track long-term effects. The study carefully monitors safety and treatment adherence throughout the participation period.

CONDITIONS

Brief Title

Hyperbaric Oxygen Therapy for Post-COVID-19 Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18 years
  • Reported post COVID-19 cognitive deterioration that affects quality of life and persists at least 3 months after confirmed infection
  • Willing and able to read, understand, and sign an informed consent
Not Eligible

You will not qualify if you...

  • Inability to attend scheduled clinic visits or comply with the study protocol
  • History of traumatic brain injury or any other non-COVID brain pathology
  • Active malignancy
  • Substance use at baseline
  • Severe or unstable physical disorders or major cognitive deficits at baseline
  • Prior hyperbaric oxygen therapy
  • Chest conditions incompatible with pressure changes including moderate to severe asthma
  • Ear or sinus conditions incompatible with pressure changes
  • Inability to perform awake brain MRI
  • Active smoking

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants will attend visits to confirm eligibility and complete baseline assessments.

Treatment

Duration - Approximately 8 weeks

Participants receive 40 daily sessions of hyperbaric oxygen therapy or sham treatment, 5 days per week for approximately 8 weeks.

40 treatment sessions conducted 5 days per week

Follow-up

Duration - Up to 1 year after treatment

Participants undergo follow-up assessments to evaluate cognitive health, brain imaging, symptom status, quality of life, and other health measures up to 1 year after treatment.

Assessments at 2 months and 1 year after baseline

Trial Site Locations

Total: 1 location

1

Assaf-Harofeh medical center

Ẕerifin, Israel, 70300

Actively Recruiting

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Research Team

S

Shani Zilberman-Itskovich, Dr.

S

Shai Efrati, Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Hyperbaric oxygen may induce angiogenesis in patients suffering from prolonged post-concussion syndrome due to traumatic brain injury.

Sigal Tal, Amir Hadanny, Nadav Berkovitz...

https://pubmed.ncbi.nlm.nih.gov/26484702

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

Rahav Boussi-Gross, Haim Golan, Gregori Fishlev...

https://pubmed.ncbi.nlm.nih.gov/24260334

The effect of hyperbaric oxygen therapy on myocardial function in post-COVID-19 syndrome patients: a randomized controlled trial.

Marina Leitman, Shmuel Fuchs, Vladimir Tyomkin...

https://pubmed.ncbi.nlm.nih.gov/37301934