Health TrialsbyHealthPanel

Hyperbaric Oxygen Therapy for Post-COVID-19 Syndrome

ConditionsCovid19Neurocognitive Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric oxygen

    Device

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

  • Sham

    Device

    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

Treatment groups

91 Participants
are divided into 2 treatment groups
Group A: HBOT treatment groupActive comparator 1 intervention
Group B: HBOT sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive health assessment (NeuroTrax)

Memory, attention and information process will be evaluated using the NeuroTrax computerized cognitive evaluation battery.

Time frame
Baseline, 2 months

Secondary outcomes

1

Brain perfusion

Cerebral blood volume and flow will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).

Time frame
Baseline, 2 months
2

Brain microstructure Brain microstructure

Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol

Time frame
Baseline, 2 months
3

Brain function imaging

Resting state fMRI (rsfMRI), and task based fmri will evaluate brain function during a working memory task

Time frame
Baseline, 2 months
4

Post-COVID-19 symptom

Self-reported questionnaire covers the most common symptoms related to post-coronavirus 2019 (COVID-19) disease

Time frame
Baseline, 2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assaf-Harofeh Medical Center

Lead sponsor

Source ClinicalTrials.gov
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