Post-COVID Syndrome.
Conditions
Interventions
Experimental group:Low-pressure oxygen supplementation therapy chamber
Control group:Atmospheric pressure oxygen therapy chamber
Sponsors
Hainan Medical College First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 75 years, inclusive, regardless of gender; 2.Meet the World Health Organization (WHO) 2021 definition for post-COVID-19 condition (PCS): Presence of symptoms that emerged within 3 months of a confirmed or probable SARS-CoV-2 infection; Symptoms have persisted for at least 2 months; Symptoms cannot be explained by an alternative diagnosis; The acute phase of COVID-19 illness must have resolved (e.g., excluding patients in the unhealed phase of severe pneumonia). 3.Clinical presentation aligns with one or more of the following subtypes: Fatigue-predominant type (analogous to chronic fatigue syndrome): Significant fatigue. Cardiopulmonary dysfunction type (reduced exercise tolerance, hypoxemia): Shortness of breath, cough, exertional dyspnea, pulmonary fibrosis; chest pain, palpitations, postural orthostatic tachycardia syndrome (POTS), myocarditis. Neurocognitive impairment type ("brain fog", cognitive decline): Brain fog (impaired attention/memory), headache, anosmia/ageusia (loss of smell/taste), sleep disturbances; anxiety, depression, post-traumatic stress disorder (PTSD); 4.Absence of pre-existing ear diseases or hearing impairment, and no large or exposed wounds. 5.Body mass index (BMI) between 18.5 kg/m^2 and 35.0 kg/m^2, inclusive. Minimum body weight must be >=50 kg for males and >=45 kg for females; 6.No history of radiotherapy or chemotherapy. No current use of immunosuppressive drugs or flavonoid-based medications; 7.Ability to comprehend and cooperate with the procedures required for pulmonary function tests; 8.The participant is capable of understanding the trial's objectives and requirements, provides voluntary participation, and has signed a written informed consent form. The participant is willing to complete the entire trial process as required.
Exclusion criteria
Exclusion criteria: 1.Individuals with claustrophobia; 2.Individuals with high myopia (>= -10.0 diopters), severe glaucoma, cataracts, or retinal detachment; 3.Individuals with severe impairment of cardiac, pulmonary, hepatic, or renal function; 4.Individuals with a history of epilepsy (excluding febrile seizures in childhood); 5.Pregnant or lactating women; 6.Individuals of childbearing potential (male and female) unwilling to use highly effective contraception for the duration of the treatment and for 12 months following the end of the study; 7.History of malignant tumors or receipt of systemic anti-cancer therapy within 5 years prior to screening; 8.Presence of active Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency Virus (HIV) infection; 9.History of organ transplantation or currently on a waiting list for organ transplantation; 10.Major surgery within 8 weeks prior to enrollment (excluding diagnostic procedures) or planned surgery during the study period; or presence of unhealed surgical wounds at the time of enrollment. 11.History of pneumonectomy; 12.Current use of anticoagulant or antiplatelet medications (e.g., aspirin, warfarin, novel oral anticoagulants); 13.Presence of severe bleeding tendency or coagulopathy; 14.History of angina pectoris, myocardial infarction, or severe hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=120 mmHg); 15.History of spontaneous pneumothorax or pneumomediastinum; severe emphysema; tuberculous cavity with hemoptysis; 16.Participation in any other clinical trial within the 3 months prior to screening; 17.Current participation in any other interventional clinical trial; 18.Poor compliance or inability to complete the study procedures, in the judgment of the investigator; 19.Any other condition deemed by the investigator to make the participant unsuitable for the trial; 20.Any other contraindication to hypobaric or hyperbaric therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood biochemistry;Urine pregnancy test (female);Coagulation function;Blood routine;Electrocardiogram parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| p16;Chest High Resolution CT;Pulse Oxygen Saturation (SpO?);TNF-a;IL-6;p21;ß-Gal staining of PBMC;Echocardiography parameters;IL-10;Questionnaire survey form(SBQ?-LC);Dynamic electrocardiogram;SASP;Pulmonary function (ventilation + diffusion); | — |
Countries
China
Contacts
Public ContactQi Li
Hainan Medical College First Affiliated Hospital
Outcome results
None listed