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Effects of Hypoxia on Multiorgan (Lung and Brain) Function in Patients with Fibrotic Interstitial Lung Disease: A Prospective, Observational Cohort Study

Effects of Hypoxia on Multiorgan (Lung and Brain) Function in Patients with Fibrotic Interstitial Lung Disease: A Prospective, Observational Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125357
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrotic interstitial lung disease

Interventions

hypoxic group:None
non-hypoxic group:None

Sponsors

General Hospital of Ningxia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged >=18 years, male or female, either outpatients or inpatients; 2. definite diagnosis of fibrotic interstitial lung disease (fILD) established by multidisciplinary discussion (MDD), including but not limited to idiopathic pulmonary fibrosis (IPF), connective tissue disease-associated ILD (CTD-ILD), fibrotic hypersensitivity pneumonitis (FHP), idiopathic nonspecific interstitial pneumonia (iNSIP), sarcoidosis, and occupational or environmental exposure-related ILD; 3. clinically stable with no acute exacerbation within the past 1 month; 4. able to communicate verbally or in writing, and willing to undergo regular follow-up; 5. voluntarily participating in this study, with written informed consent obtained and approved by the ethics committee of each participating center.

Exclusion criteria

Exclusion criteria: 1. presence of other severe pulmonary diseases (e.g., lung cancer, asthma, COPD) or cardiovascular diseases (e.g., left heart failure, malignant arrhythmias); 2. presence of conditions leading to hypoxia, such as severe anemia, carbon monoxide poisoning, or cyanotic congenital heart disease; 3. presence of active infection, malignancy, or an immunocompromised state; 4. receipt of lung transplantation or participation in other interventional clinical trials within the recent 6 months; 5. presence of neuropsychiatric disorders, such as cerebrovascular disease, Parkinson's disease, or depression; 6. refusal of participation by the patient or their family members.

Design outcomes

Primary

MeasureTime frame
change in Forced Vital Capacity (FVC);change in Montreal Cognitive Assessment Score;

Secondary

MeasureTime frame
Incidence of acute exacerbation;Change in HRCT fibrosis score;KBILD score;Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls questionnaire, SARC-F;Fatigue Assessment Scale score;Incidence of death;change in 6-Minute Walk Distance (6MWD);Hospital Anxiety and Depression Scale;KL-6;Differential brain regions and abnormal functional nodes on brain MRI;

Countries

China

Contacts

Public ContactChen Juan

General Hospital of Ningxia Medical University

Chenjuan7419@163.com+86 130 1429 2231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026