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

February 6, 2023 updated by: The First Affiliated Hospital of Zhejiang Chinese Medical University

The Effects of Hyperbaric Oxygen Therapy on Brain Function in Patients With Cognitive Decline After COVID-19 Infection.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • First Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Chenjuan Wang, M.M.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: hyperbaric oxygen therapy
Ten sessions of hyperbaric oxygen therapy were completed within 4 weeks of enrollment.
Procedure: hyperbaric oxygen therapy
The hyperbaric oxygen group was given 60 minutes of pure oxygen under 2ATA (Atmosphere Absolute, ATA) and 5 minutes of rest in between.
ACTIVE_COMPARATOR: conventional oxygen therapy
Ten sessions of conventional oxygen therapy were completed within 4 weeks after enrollment.
Procedure: conventional oxygen therapy
Conventional oxygen therapy group breathed 27% oxygen at 1.03 ATA for 60 minutes. (The chamber pressure was increased to 1.2ATA with circulating air noise for the first 5 minutes of the experiment, then reduced to 1.03 ATA for the next 5 minutes.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scores of Montreal Cognitive Scale (MoCA)
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
The total score is 30 points, and the cut-off value for MCI is identified:≤19 points(illiterate and primary school group);≤22 points(Middle school group); ≤24 points(University group).
The patients would be followed up for 3 months after oxygen therapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Electroencephalography
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
The main frequency distribution and absolute power spectrum of 4 frequency bands (δ (1-3.9 Hz) , θ (4-7 Hz) , α (8-12.9 Hz) and β (13-30 Hz) were obtained, the θ frequency and the relative power of δ frequency (DTABR = (δ + θ)/(α + β)) were calculated.
The patients would be followed up for 3 months after oxygen therapy.
Brain magnetic resonance imaging (MRI), brain functional magnetic resonance imaging (fMRI)
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
The time series acquired from resting-state fMRI will be transformed into the frequency domain using Fast Fourier transform, and the square root of the power spectrum will be calculated and averaged across 0.01-0.08 Hz within each voxel.The ALFF of each voxel will be divided by the global mean ALFF value to standardize data across subjects.
The patients would be followed up for 3 months after oxygen therapy.
Boston naming test
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
Total score is 30 points.The cut-off values for each group are:≦19(Junior high school education level),≦21(High school education level),≦22(University education level)
The patients would be followed up for 3 months after oxygen therapy.
auditory verbal learning test，AVLT
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
A 12-word list was repeated 3 times, and short-delayed recall was performed after an interval of 3-5 minutes, and long-delayed recall, cued recall and recognition were performed after an interval of 20 minutes. The most sensitive evaluation indexes were long-delayed recall score and recognition score. The auxiliary indexes included immediate recall score, total recall score, recall skills and discrimination. Cut-off values: long delayed recall score ≤5 (50-59 years), ≤4 (60-69 years), ≤3 (70-79 years);Recognition score ≤20 (50-59 years), ≤19 (60-69 years), ≤18 (70-79 years).
The patients would be followed up for 3 months after oxygen therapy.
The Shape Trail Making Test A and B(STT-A&B)
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
The Shape Trail Making Test A and B(STT-A&B) is divided into two parts: A and B. Each part includes exercises and tests. Part A asks participants to connect random numbers in sequence as quickly as possible. Part B asks participants to connect numbers in sequence alternately. Rating: Mainly record the amount of time spent. Cut-off value: STT-A test questions, 50~59 years old ≥70s, 60~69 years old ≥80s, 70~79 years old ≥100s;STT-B test questions, 50~59 years old ≥180s, 60~69 years old ≥200s, 70~79 years old ≥240s. The longer it takes, the worse it gets.
The patients would be followed up for 3 months after oxygen therapy.
Animal word fluency (AFT)
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
Subjects were asked to list as many examples of animals as possible within 1 min. Cut-off value: animal fluency score ≤12(junior high school group) , ≤13(senior high school group) , ≤14(university group)
The patients would be followed up for 3 months after oxygen therapy.
Stroop color words test
Time Frame: The patients would be followed up for 3 months after oxygen therapy.
The stroop test lasts for 45 seconds, and the correct number of each test is calculated.Cut-off value: animal fluency score ≤12(junior high school group) , ≤13(senior high school group) , ≤14(university group)
The patients would be followed up for 3 months after oxygen therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Investigators

  • Study Chair: Jiannong Wu, M.D., First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 29, 2023

Primary Completion (ANTICIPATED)

January 31, 2024

Study Completion (ANTICIPATED)

January 31, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KLS-018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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