Hyperbaric Oxygen Therapy Improves Brain Function in Patients With Cognitive Decline After COVID-19 Infection.

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status: Not yet enrolling

Conditions: COVID-19; SARS CoV 2 Infection; Cognitive Decline

Treatments: Procedure: hyperbaric oxygen therapy; Procedure: conventional oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05715801

2023-KLS-018-01

Details and patient eligibility

About

COVID-19 has swept the world, and while some people may experience long-term cognitive decline as a result of infection, no effective treatment has been announced. The primary goal of this study was to determine the efficacy of hyperbaric oxygen therapy in patients with SARS-CoV-2 infection, as well as to assess the effect of hyperbaric oxygen therapy on brain function in patients with COVID-19-related cognitive decline. In this study, approximately 80 people were randomly assigned to either hyperbaric oxygen or regular oxygen therapy to compare the effects of these two treatments on disease.

Full description

80 patients with cognitive impairment following a novel coronavirus infection will be randomly assigned to one of two treatment groups: hyperbaric oxygen therapy or conventional oxygen therapy.

After the intervention, the improvement of hyperbaric oxygen on cognition, fatigue, sleep disorders, anxiety and depression, and other clinical manifestations was observed. The neurologic function of hyperbaric oxygen in the treatment of patients with cognitive decline after SARS-CoV-2 infection was also evaluated from imaging and electrophysiological multi-dimensional indexes.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Out-patients 4 weeks after the diagnosis of SARS-CoV-2 infection
• Subjective cognitive decline after SARS-CoV-2 infection
• SARS-CoV-2 nucleic acid/antigen test negative.

Exclusion criteria

• Contraindications to hyperbaric oxygen therapy
• Cognitive decline can be explained by other diseases
• Conditions that researchers consider unsuitable for clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

hyperbaric oxygen therapy

Experimental group

Description:

Ten sessions of hyperbaric oxygen therapy were completed within 4 weeks of enrollment.

Treatment:

Procedure: hyperbaric oxygen therapy

conventional oxygen therapy

Active Comparator group

Description:

Ten sessions of conventional oxygen therapy were completed within 4 weeks after enrollment.

Treatment:

Procedure: conventional oxygen therapy