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Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study

Study Purpose

The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous studies. There is only a limited number of therapeutic options for patients with severely progressed interstitial lung disease (ILD). The question whether chronic hypercapnic ILD-patients are able to profit from nocturnal NIV and thus increase their performance in physical training has been left unknown. Therefore, this study aims to evaluate the feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary rehabilitation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- confirmed diagnosis of Interstitial lung disease.

- Hypercapnia defined as carbon dioxide partial pressure ≥45 mmHg (at rest, night or activity) - already existing but not sufficient and regular use of non-invasive ventilation (≤3h/24h) - patients consent to participate in this trial.

Exclusion Criteria:

- acute pulmonary insufficiency (ph<7.35) - acute, clinically relevant heart disease.

- already existing and sufficient use of non-invasive ventilation (≥3h/24h) - Body-Mass-Index>30.

- obstructive sleep apnea.

- Intolerance to perform non-invasive ventilation.

- acute infection

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02377739
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Schön Klinik Berchtesgadener Land
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Klaus Kenn, MD
Principal Investigator Affiliation	Schoen Klinik Berchtesgadener Land
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Noninvasive Ventilation, Lung Diseases, Interstitial

Arms & Interventions

Arms

Experimental: non-invasive ventilation

patients will undergo about 14 nights of non-invasive ventilation during pulmonary rehabilitation

Interventions

Other: - non-invasive ventilation

patients will undergo a nocturnal non-invasive ventilation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.