search
Back to results

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

Primary Purpose

Cognitive Decline, COVID-19, SARS CoV 2 Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hyperbaric oxygen therapy
conventional oxygen therapy
Sponsored by
The First Affiliated Hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Decline

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital of Zhejiang Chinese Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hyperbaric oxygen therapy

conventional oxygen therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

scores of Montreal Cognitive Scale (MoCA)
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).

Secondary Outcome Measures

Quantitative Electroencephalography
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.
Brain magnetic resonance imaging (MRI), brain functional magnetic resonance imaging (fMRI)
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.
Boston naming test
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)
auditory verbal learning test,AVLT
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 Shape Trail Making Test A and B(STT-A&B)
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.
Animal word fluency (AFT)
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)
Stroop color words test
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)

Full Information

First Posted
February 1, 2023
Last Updated
February 6, 2023
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05715801
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 29, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, COVID-19, SARS CoV 2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
Ten sessions of hyperbaric oxygen therapy were completed within 4 weeks of enrollment.
Arm Title
conventional oxygen therapy
Arm Type
Active Comparator
Arm Description
Ten sessions of conventional oxygen therapy were completed within 4 weeks after enrollment.
Intervention Type
Procedure
Intervention Name(s)
hyperbaric oxygen therapy
Intervention Description
The hyperbaric oxygen group was given 60 minutes of pure oxygen under 2ATA (Atmosphere Absolute, ATA) and 5 minutes of rest in between.
Intervention Type
Procedure
Intervention Name(s)
conventional oxygen therapy
Intervention Description
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.)
Primary Outcome Measure Information:
Title
scores of Montreal Cognitive Scale (MoCA)
Description
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).
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Secondary Outcome Measure Information:
Title
Quantitative Electroencephalography
Description
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.
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Title
Brain magnetic resonance imaging (MRI), brain functional magnetic resonance imaging (fMRI)
Description
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.
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Title
Boston naming test
Description
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)
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Title
auditory verbal learning test,AVLT
Description
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).
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Title
The Shape Trail Making Test A and B(STT-A&B)
Description
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.
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Title
Animal word fluency (AFT)
Description
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)
Time Frame
The patients would be followed up for 3 months after oxygen therapy.
Title
Stroop color words test
Description
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)
Time Frame
The patients would be followed up for 3 months after oxygen therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Jiang, M.D.
Phone
13575757710
Email
jiangyan@zcmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shan Liu, M.M.
Phone
18806715135
Email
graystar92@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiannong Wu, M.D.
Organizational Affiliation
First Affiliated Hospital of Zhejiang Chinese Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiannong Wu, M.D.
Phone
13777571598
Email
13777571598@163.com
First Name & Middle Initial & Last Name & Degree
Yan Jiang, M.D.
Phone
13575757710
Email
Jiangyan@zcmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Chenjuan Wang, M.M.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs