Clinical trial NCT05715801: Hyperbaric Oxygen Therapy Improves Brain Function in Patients With Cognitive Decline After COVID-19 Infection.
Official title: The Effects of Hyperbaric Oxygen Therapy on Brain Function in Patients With Cognitive Decline After COVID-19 Infection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Decline
COVID-19
SARS CoV 2 Infection
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: scores of Montreal Cognitive Scale (MoCA)
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
Secondary outcomes:
measure: Quantitative Electroencephalography
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
measure: Brain magnetic resonance imaging (MRI), brain functional magnetic resonance imaging (fMRI)
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
measure: Boston naming test
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
measure: auditory verbal learning test，AVLT
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
measure: The Shape Trail Making Test A and B(STT-A&B)
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
measure: Animal word fluency (AFT)
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
measure: Stroop color words test
timeFrame: The patients would be followed up for 3 months after oxygen therapy.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang Chinese Medical University
name: Jiannong Wu, M.D.
role: STUDY_CHAIR
References: