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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05715801
• Other study ID #: 2023-KLS-018-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 29, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Contact: Yan Jiang, M.D.
• Phone: 13575757710
• Email: jiangyan[@]zcmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Communicable Diseases
• COVID-19
• Infections

Intervention

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.
• 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.)

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The patients would be followed up for 3 months after oxygen therapy.
Secondary	Quantitative Electroencephalography	The main frequency distribution and absolute power spectrum of 4 frequency bands (d (1-3.9 Hz) , ? (4-7 Hz) , a (8-12.9 Hz) and ß (13-30 Hz) were obtained, the ? frequency and the relative power of d frequency (DTABR = (d + ?)/(a + ß)) were calculated.	The patients would be followed up for 3 months after oxygen therapy.
Secondary	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.	The patients would be followed up for 3 months after oxygen therapy.
Secondary	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)	The patients would be followed up for 3 months after oxygen therapy.
Secondary	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 patients would be followed up for 3 months after oxygen therapy.
Secondary	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.	The patients would be followed up for 3 months after oxygen therapy.
Secondary	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)	The patients would be followed up for 3 months after oxygen therapy.
Secondary	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)	The patients would be followed up for 3 months after oxygen therapy.