Skip to main content
. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

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
  1. Remote monitoring while patient sleeps utilising non‐invasive equipment

  2. UC to receive equipment after study period

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