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

NCT ID: NCT05715801

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-29

Study Completion Date

2024-01-31

Brief Summary

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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

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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

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Cognitive Decline COVID-19 SARS CoV 2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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hyperbaric oxygen therapy

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

Group Type EXPERIMENTAL

hyperbaric oxygen therapy

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

conventional oxygen therapy

Intervention Type PROCEDURE

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.)

Interventions

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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.

Intervention Type 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.)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiannong Wu, M.D.

Role: STUDY_CHAIR

First Affiliated Hospital of Zhejiang Chinese Medical University

Locations

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First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Yan Jiang, M.D.

Role: CONTACT

13575757710

Shan Liu, M.M.

Role: CONTACT

18806715135

Facility Contacts

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Jiannong Wu, M.D.

Role: primary

13777571598

Yan Jiang, M.D.

Role: backup

13575757710

Other Identifiers

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2023-KLS-018-01

Identifier Type: -

Identifier Source: org_study_id

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