FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding why some patients with fibrotic interstitial lung disease (fILD), a type of lung condition that causes scarring in the lungs, experience worsening symptoms. Researchers want to see if measuring oxygen levels during sleep and exercise can help identify which patients are at higher risk of their condition getting worse. This study is observational, meaning they will watch and gather information from participants without changing their treatment.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with fILD, which includes conditions like idiopathic pulmonary fibrosis or chronic hypersensitivity pneumonitis. It's important that you can provide written consent to join. However, there are some reasons you might not be eligible, such as needing long-term oxygen therapy or having certain heart and lung conditions. If you do join, you'll be asked to complete some health questionnaires and participate in tests that measure your exercise capacity, like a 6-minute walk test. This study is currently not recruiting participants yet, but it aims to provide valuable insights into how to better care for patients with fILD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18 year and over
• • 2. Tertiary MDT diagnosis of FILD with \>10% fibrosis on CT chest as determined by the investigator. Underlying diagnoses to include but not limited to: idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), connective tissue disease-related interstitial lung disease (CTD-ILD), fibrotic organising pneumonia (FOP) and pulmonary sarcoidosis.
• • 3. Able to provide informed written consent
• Exclusion Criteria:
• • 1. The use of or any indication for long-term oxygen therapy (LTOT)
• • 2. Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour
• • 3. Radiological predominance of emphysema compared with fibrosis on CT chest
• • 4. Inability to complete all health status questionnaires as set out in this protocol, with appropriate support
• • 5. A confirmed diagnosis of pulmonary hypertension
• • 6. Significant cardiovascular comorbidity including severe, uncontrolled hypertension, uncontrolled arrhythmia, recent acute coronary syndrome within 30 days prior to study enrolment, that could mean exercise testing poses a risk to patient health, in the opinion of the investigator
• • 7. Musculoskeletal comorbidity that will preclude the participant's ability to reliably complete the complete 6-minute walk test (6MWT)
• • 8. Participation in another research project which may confound this study's research findings