TABLE 2

Outcome measures for modified intention-to-treat analyses

Baseline6 monthsMean difference (95% CI)p-value
Subjects n2222
Sleep disordered breathing
 AHI events·h−123.7±12.212.9±10.110.8 (14.6–7.0)<0.0001
 ODI events·h−119.1±11.29.8±6.99.3 (13.1–5.5)<0.0001
SaO2 <90% % time5.0±6.02.1±3.02.9 (4.6–1.3)0.0015
 Apnoea index events·h−110.1±10.25.6±8.44.8 (9.2–0.4)0.0334
 Hypopnoea index events·h−112.5±8.97.6±6.24.9 (8.1–1.7)0.0049
Symptoms
 ESS11.0±5.3#8.0±5.43.0 (5.7–0.8)0.0113
 FOSQ-1015.3±3.317.2±3.01.9 (0.4–3.4)0.0157
Sleep architecture
 Sleep efficiency %84.0±10.887.3±8.93.2 (0.01–6.4)0.0494
 NREM stage 1 %13.1±7.98.2±4.05.0 (8.3–1.7)0.0053
 NREM stage 2 %60.9±8.767.6±9.56.7 (2.2–11.3)0.0058
 NREM stage 3 %8.2±6.93.5±4.34.7 (6.6–2.7)<0.001
 REM %17.8±6.420.7±7.32.9 (−0.3–6.2)0.0782
 Arousal index events·h−128.7±11.516.0±8.012.7 (16.6–8.9)<0.0001

Data are presented as mean±sd or mean (95% CI), unless otherwise stated. AHI: apnoea–hypopnoea index; ODI: 4% oxygen desaturation index; SaO2 <90%: proportion of the night spent at an oxygen saturation <90%; ESS: Epworth Sleepiness Scale; FOSQ-10: 10-item Functional Outcomes of Sleep Questionnaire; NREM: non-rapid eye movement; REM: rapid eye movement. #: n=21.