Investigation of utility of Hyperbaric Oxygen Treatment (HBOT) for Long-COVID syndrome

Phase 1

• Conditions: ong COVID; Long COVID; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622001428752
• Lead Sponsor: Wesley Hyperbaric

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-08
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•18 to 65-year old
•COVID-19 at least 12 weeks prior, +PCR test/ RAT and/or documented clinical symptoms
•Active lifestyle before contracting COVID-19

Exclusion Criteria

•Pregnant or lactating women
•Individuals that are unable walk or get in and out of bed by themselves unaided
•Inability to provide written informed consent
•Inability or unwillingness to adhere to 10 HBOT treatment sessions over a 2 to 3 week- time period or to complete questionnaires/testing
•Claustrophobia and inability to enter the hyperbaric chamber for session
•Inability to effectively equalise the middle ear during ambient pressure changes. History of tympanic membrane perforation, head and neck surgery with compromised Eustachian tube function, including tracheostomy, mastoidectomy, middle ear surgical procedures and cochlear implants
•Contraindication to HBOT such as cardiac or respiratory contraindication, bleomycin, spherocytosis or pulmonary fibrosis
•Involved in another clinical trial that does not allow enrolment in other clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurocognitive assessment measured by Neurotrax software. A computer-based neurocognitive assessment.[ Baseline and 3 months post-treatment completion]

Secondary Outcome Measures

Name	Time	Method
ung function testing with bedside vitalograph measuring FEV1 and PEFR.[Baseline and 3 months post-treatment];Chalder fatigue scale[Baseline,3 months and 6 months post-treatment completion];one min sit to stand test to define exercise capacity[Baseline and 3 months post-treatment];adverse side effects such as barotrauma, CNS oxygen toxicity, or myopia (all routinely collected for all patients undergoing HBOT). The participants have daily checks to ensure they have no complications and this is recorded in our medical records and also collated as deidentified data for our national data registry of side effects which all chambers in Australia contribute to for quality assurance.[Immediately on Completion of HBOT treatment and again at the three-month post completion visit.]