A multicentre randomised controlled trial and economic evaluation of continuous positive airway pressure for the treatment of obstructive sleep apnoea syndrome in older people: PREDICT

• DOI: 10.3310/hta19400
• Publication Date: 2015-06-12T07:03:18Z
• Authors: Alison McMillan; Daniel J Bratton; Rita Faria; Magda Laskawiec-S...; Susan Griffin; Robert J Davies; Andrew J Nunn; John R Stradling; Renata L Riha; Mary J Morrell
• Keywords: Epworth Sleepiness Scale

Background The therapeutic and economic benefits of continuous positive airway pressure (CPAP) for the treatment obstructive sleep apnoea syndrome (OSAS) have been established in middle-aged people. In older people there is a lack evidence. Objective To determine clinical efficacy CPAP with OSAS to establish its cost-effectiveness. Design A randomised, parallel, investigator-blinded multicentre trial within-trial model-based cost-effectiveness analysis. Methods Two hundred seventy-eight patients, aged ≥ 65 years newly diagnosed [defined as oxygen desaturation index at 4% threshold level > 7.5 events/hour Epworth Sleepiness Scale (ESS) score 9] recruited from 14 hospital-based services across UK. Interventions best supportive care (BSC) or BSC alone. Autotitrating was initiated using standard practice. structured advice on minimising sleepiness. Coprimary outcomes Subjective sleepiness 3 months, measured by ESS (ESS mean score: months 4) over 12 quality-adjusted life-years (QALYs) calculated European Quality Life-5 Dimensions (EQ-5D) health-care resource use, information which collected monthly patient diaries. Secondary 10, 11 12) objective sleepiness, disease-specific generic quality life, mood, functionality, nocturia, mobility, accidents, cognitive function, cardiovascular risk factors events months. Results patients were randomised ( n = 140) 138) 27 231 (83%) completed trial. Baseline similar both groups [mean (standard deviation; SD) 11.5 (3.3), 11.4 (4.2)]; well balanced other characteristics. (SD) –3.8 (0.4) group –1.6 (0.3) group. adjusted effect compared –2.1 points [95% confidence interval (CI) –3.0 –1.3 points; p < 0.001]. At –2.0 (95% CI –2.8 –1.2 0.001). greater increased use higher baseline score. number QALYs EQ-5D marginally (0.005) than –0.034 0.044). average cost per £1363 £1121 £1606) those allocated £1389 £1116 £1662) BSC. On average, costs lower (mean –£35; 95% –£390 £321). probability that cost-effective thresholds conventionally used NHS (£20,000 QALY gained) 0.61. Short Form questionnaire-6 0.018 0.003 0.034 QALYs) 0.96. decreased 0.02), mobility 0.03) reduced total low-density lipoprotein cholesterol 0.05, 0.04, respectively) but not group, fall systolic blood 3.7 mmHg seen 0.04). Mood, function unchanged. There no medically significant harms attributable CPAP. Conclusion OSAS, reduces more Further work required identification potential biomarkers impairment. Early detection could be inform clinician when disease cycle needed avert central nervous system sequelae assist decision-making regarding compliance. Treatment adherence also challenge trials generally, therapy particular recognised concern research studies Suggested priorities would include focus optimisation delivery support embracing technological advances currently available. Finally, improvements life do appear reflect dramatic changes noted should centred better capture symptomatic improvement translate these into health Trial registration Current Controlled Trials ISRCTN90464927. Funding This project funded National Institute Health Research (NIHR) Technology Assessment programme will published full ; Vol. 19, No. 40. See NIHR Journals Library website further information.