Table 1 Applicability of procedures per study visit. V0–V8 study visits, M1–M36 visit time in months, 1D/15D visit tolerance in days, 1 if not done previously, 2 if follow-up necessary, 3 hand-out of diary; * only for 3 home NIV arms

Patient information and consent

x

Inclusion/exclusion criteria

x

Demographic data

x

Medical history

x

 • Spirometry

x

1/2

1/2

 • 6-minute walk test

x

x

1

 • Diaphragmatic dys function

x

QoL questionnaires

x

x

x

x

x

x

x

x

x

QoS questionnaires

x

x

x

x

x

x

x

x

x

Dyspnea questionnaire

x

x

x

x

x

x

x

x

x

Charlson comorbidity

x

Tobacco use

x

x

x

x

x

x

x

x

x

Exacerbations

3

x

x

x

x

x

x

x

x

• Blood gases (PaO2, PaCO2, SpO2)

x

x

x

x

x

x

x

x

x

• PTCO2

x

x

x

x

x

x

x

x

x

• Poly(somno)graphy

x

2

• Cardiac echography

x

2

Randomization

x

Fitting/Settings of ventilator*

x

x

x

x

x

x

x

x

x

Concomitant medication

x

x

x

x

x

x

x

x

x

Device data *

x

x

x

x

x

x

x

x

Adverse events/ hospitalizations

x

x

x

x

x

x

x

x

Educational session

x

x

x

x

x

x

x

x

x