Cognitive DeclineNCT05715801
Hyperbaric Oxygen Therapy Improves Brain Function in Patients With Cognitive Decline After COVID-19 Infection.
A study testing hyperbaric oxygen therapy and conventional oxygen therapy in people with Cognitive Decline and COVID-19, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Decline, COVID-19, SARS CoV 2 Infection
- What is being tested?
- hyperbaric oxygen therapy and conventional oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to hyperbaric oxygen therapy
- Cognitive decline can be explained by other diseases
- Conditions that researchers consider unsuitable for clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
Jiannong Wu, M.D., 13777571598, 13777571598@163.com
Yan Jiang, M.D., 13575757710, Jiangyan@zcmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Decline, COVID-19, SARS CoV 2 Infection
- Being tested
- hyperbaric oxygen therapy, conventional oxygen therapy
- Medical subject headings
- Cognitive Dysfunction, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyProcedure or surgery
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 therapyProcedure or surgery
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.)
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | Ten sessions of hyperbaric oxygen therapy were completed within 4 weeks of enrollment. Receives: Procedure: hyperbaric oxygen therapy |
| conventional oxygen therapy | Active comparator | Ten sessions of conventional oxygen therapy were completed within 4 weeks after enrollment. Receives: Procedure: conventional oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The patients would be followed up for 3 months after oxygen therapy.
Secondary outcomes (7)
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.
Measured: The patients would be followed up for 3 months after oxygen therapy.
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.
Measured: The patients would be followed up for 3 months after oxygen therapy.
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)
Measured: The patients would be followed up for 3 months after oxygen therapy.
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).
Measured: The patients would be followed up for 3 months after oxygen therapy.
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.
Measured: The patients would be followed up for 3 months after oxygen therapy.
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)
Measured: The patients would be followed up for 3 months after oxygen therapy.
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)
Measured: The patients would be followed up for 3 months after oxygen therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start29 Jan 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiannong Wu, M.D., Study chair, First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715801
- Sponsor's protocol ID
- 2023-KLS-018-01
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyperbaric Oxygen Therapy on Brain Function in Patients With Cognitive Decline After COVID-19 Infection.
- ClinicalTrials.gov ID
- NCT05715801
- Acronym / sponsor ID
- 2023-KLS-018-01
- Conditions
- Cognitive Decline, COVID-19, SARS CoV 2 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 29 Jan 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | Procedure: hyperbaric oxygen therapyTen sessions of hyperbaric oxygen therapy were completed within 4 weeks of enrollment. |
| conventional oxygen therapy | Active comparator | Procedure: conventional oxygen therapyTen sessions of conventional oxygen therapy were completed within 4 weeks after enrollment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Contraindications to hyperbaric oxygen therapy
- Cognitive decline can be explained by other diseases
- Conditions that researchers consider unsuitable for clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyThe hyperbaric oxygen group was given 60 minutes of pure oxygen under 2ATA (Atmosphere Absolute, ATA) and 5 minutes of rest in between. | Procedure or surgery | hyperbaric oxygen therapy |
| conventional oxygen therapyConventional 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.) | Procedure or surgery | conventional oxygen therapy |
Primary outcome
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).
7 secondary outcomes
Quantitative Electroencephalography
Time frame: 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.
Boston naming test
Time frame: 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.
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.
Animal word fluency (AFT)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Decline
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiannong Wu, M.D. study chair
First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy and conventional oxygen therapy in people with Cognitive Decline and COVID-19, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Jiang, M.D. (13575757710, jiangyan@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores of Montreal Cognitive Scale (MoCA) (time frame: The patients would be followed up for 3 months after oxygen therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.