Target population | ≥70 years of age with OSA | ≥65 years of age with OSA |
Setting | Spain (12 clinical centres) | UK (14 clinical centres) |
Design | Randomised multicentre clinical trial with a blinded design | Randomised multicentre clinical trial with a blinded design |
Participants in CPAP/control groups | 115/109 | 140/138 |
Selection criteria |
Inclusion | Age ≥70 years, AHI ≥30 events per h, current use of CPAP, central sleep apnoea, incapacitating hypersomnia | Age ≥65 years, OSA, AHI ≥7 events per h, ESS ≥9, ODI >4% |
Exclusion | Severe heart failure, a cardiovascular event in the month prior to the inclusion in the study, ESS ≥18, severe impairment of cognitive. | CPAP therapy (previous study), SpO2 (vigil) <90%, FEV1/FVC <60%, being a professional driver, reporting sleepiness while driving, shift work |
Intervention CPAP/control group | Treatment with CPAP and health education/health education | Treatment with CPAP and health education/health education |
Mean follow-up months | 3 | 12 |
Primary end-point | QSQ | ESS, cost-effectiveness |
Secondary end-points | Neurocognitive battery test, HADS Blood pressure measurements | SAQLI, OSLER, EQ-5D, SF-36, cardiovascular risk factor |
Age years mean±sd | 75±3.9 | 71.1±4.6 |
Men/women | 153 (68%)/71 (32%) | 229 (83.38%)/49 (16.62%) |
BMI kg·m−2 CPAP/control mean±sd | 33.0±7.3/32.8±5.1 | 33.9±5.7/33.6±6.4 |
| QSQ | SAQLI total |
Hypersomnolence | Diurnal symptoms | 3 months | 12 months |
Treatment effect (95% CI) | −0.612 (−0.894– −0.331) | −0.778 (−1.049– −0.506) | 0.3 (0.1–0.5) | 0.4 (0.2–0.6) |
p-value | <0.001 | <0.001 | 0.005 | 0.001 |
| Nocturnal symptoms | Emotions | Social interaction | | | |
Treatment effect (95% CI) | −0.958 (−1.249– −0.668) | −0.597 (−0.864– −0.331) | −0.546 (−0.833– −0.259) | | | |
p-value | <0.001 | <0.001 | <0.001 | | | |
ESS mean±sd | Baseline | 3 months | Baseline | 3 months | 12 months |
CPAP group | 9.56±4.0 | 5.94±3.41 | 11.6±3.4 | 7.7±0.4 | 5.7±1.2 |
Control group | 9.33±3.62 | 9.22±3.99 | 11.6±3.4 | 9.8±0.4 | 9.1±1.2 |
p-value | >0.05 | <0.001 | >0.05 | 0.002 | 0.002 |