ClinicalTrialsFinder
RecruitingNot ApplicableNCT04647656

Hyperbaric Oxygen Therapy for Post-COVID-19 Syndrome

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

Sponsor

Assaf-Harofeh Medical Center

Enrollment

91 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Summary

Post-COVID-19 syndrome is an assembly of symptoms, following an infection with Coronavirus disease 2019 (COVID-19). The syndrome is characterized by cognitive impairment, fatigue, sleep disorders, smell and taste disorders, pain and more. This long-term sequela can last for months after recovering from the virus, and no treatment is known to date. The aim of this study is to compare the effect of HBOT vs. Sham on post COVID-19 syndrome

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age above 18 years
  • Reported post COVID-19 cognitive deterioration that effect quality of life and persist at least 3 months after confirmed infection.
  • Subject willing and able to read, understand and sign an informed consent

Exclusion Criteria10

  • Inability to attend scheduled clinic visits and/or comply with the study protocol
  • History of traumatic brain injury (TBI) or any other non COVID brain pathology
  • Active malignancy
  • Substance use at baseline
  • Severe or unstable physical disorders or major cognitive deficits at baseline
  • HBOT for any reason prior to study enrolment
  • Chest pathology incompatible with pressure changes (including moderate to severe asthma)
  • Ear or Sinus pathology incompatible with pressure changes
  • An inability to perform an awake brain MRI
  • Active smoking

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHyperbaric oxygen

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

DEVICESham

Each session will include exposure of 90 minutes to 21% at 1.2 ATA during the first five minutes of the session with the noise of circulating air, and then decrease slowly during the next five minutes to 1.03 ATA

Locations(1)

Assaf-Harofeh medical center

Ẕerifin, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04647656