Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03901534
Eligibility Criteria:
Inclusion Criteria for Patients with ILD:
1. Ability to provide informed consent.
2. Age 18 years or greater
3. Diagnosis of any of the following fibrotic interstitial lung diseases as defined by ATS/ERS/JRS/ALAT guidelines and research statements and Delphi surveys:
* Idiopathic pulmonary fibrosis
* Idiopathic non-specific interstitial pneumonia (NSIP) with fibrosis
* Chronic hypersensitivity pneumonitis with fibrosis
* Connective tissue disease related interstitial lung disease (CTD-ILD)
* Unclassifiable idiopathic interstitial pneumonia with fibrosis
Exclusion criteria for Patients with ILD:
1. Clinically significant lung disease other than fibrotic interstitial lung disease
2. Planned change to the IPF treatment during the study period
3. Current cigarette smoking (past 4 weeks)
4. Lower respiratory tract infection in past 60 days. (Upper respiratory tract infection is not a contraindication)
5. History of life-threatening cardiac arrhythmias
6. Known chronic heart failure (LVEF \< 45% or echo evidence of RV dysfunction or PH)
7. Chronic opiate analgesic use
8. History of sleepiness-related automobile accident within past year of enrollment
9. Expected survival time in the opinion of the investigator of less than 6 months
10. History of stroke or spinal cord injury
Inclusion criteria for OSA patients:
1. Age 18 years or greater
2. Clinical diagnosis of untreated OSA documented by nocturnal polysomnography
Exclusion criteria for OSA patients:
1. Current treatment with CPAP or oral appliance
2. Identical exclusion criteria as for ILD patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03901534
Study Brief:
Protocol Section:
NCT03901534