NCT01560741.
Methods |
Study design: unknown centres; double‐blinded, parallel individual randomised controlled trial in Portugal Duration: 36 weeks Setting: hospital |
Participants |
Population: 128 adults recruited from Portugal Baseline characteristics: unknown Inclusion criteria: < 80 years of age, PaCO₂ > 45 mmHg, IMC > 40 kg/m², LTOT for at least 3 months, 1 exacerbation in last year, FEV₁ < 50%predicted, FEV₁/FVC < 60%, TLC > 90% predicted, GOLD guidelines therapy, pH > 7.35, free of exacerbations 4 weeks before recruitment Exclusion criteria: OHS: COPD, NMD; COPD: 15% increase in FEV₁ after inhaled salbutamol (200 μg), actively smoking, history of OSA; NMD and CWD: COPD; OHS; PCF < 270; MIC/VC = 1, severe bulbar weakness |
Interventions | Measurements taken at baseline, at 12 weeks, and at end of study Treatment arms
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Outcomes |
Primary outcomes: difference of 1 hour in the mean of nightly hours of use Secondary outcomes: QOL, health economics, arterial blood gases |
Notes |
Funding: Hospital Sao Joao Other identifier:NCT01560741; TeleMotiNIV2012 |