Sara Wallström1,2, Baran Balcan3, Erik Thunström4, Axel Wolf1,2, Yüksel Peker4,5,6,7. 1. Institute of Health and Care Sciences, University of Gothenburg, Sweden. 2. Centre for Person-Centred Care (GPCC), University of Gothenburg, Sweden. 3. Department of Pulmonary Medicine, Marmara University, School of Medicine, Istanbul, Turkey. 4. Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 5. Department of Clinical Sciences, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden. 6. Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania. 7. Department of Pulmonary Medicine, Koc University, School of Medicine, Istanbul, Turkey.
Abstract
STUDY OBJECTIVES: To determine the effect of continuous positive airway pressure (CPAP) treatment on health-related quality of life (HRQoL) in adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA). METHODS: This was a secondary outcome analysis of the RICCADSA trial, conducted in Sweden between 2005 and 2013. Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI] ≥ 15 events/h; Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires at baseline and after 12 months were included. Patients were randomized to CPAP (n = 102) or no CPAP (n = 104). The primary outcome was the between-group difference in absolute change in the SF-36 components. Within-group changes as well as variables associated with absolute change in the domains in the entire population were also tested. RESULTS:Mean SF-36 scores were similar at baseline, ranging from 44.9 ± 9.6 to 92.2 ± 15.8 in various domains, and between-group changes from baseline were not statistically significant at 1 year. There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group. The change in Physical Component Summary (PCS) was determined by female sex (beta coefficient -0.19, 95% confidence interval [CI] -7.25 to -0.98, P = .010), baseline AHI (beta coefficient -0.19, 95% CI -0.21 to -0.03, P = .009), CPAP use (h/night) (beta coefficient -0.16, 95% CI -0.93 to -0.06, P = .028), and acute myocardial infarction at baseline (beta coefficient 0.18, 95% CI 0.59 to 5.19, P = .014). Determinants of the change in MCS from baseline were change in the ESS score (beta coefficient -0.14, 95% CI -0.87 to -0.01, P = .054) and change in the Zung Self-rated Depression Scale scores (beta coefficient -0.33, 95% CI -0.58 to -0.24, P < .001). CONCLUSIONS: Assignment to CPAP treatment compared to no CPAP had no significant effect on HRQoL as measured by the SF-36 in adults with CAD and nonsleepy OSA. Although several components of the SF-36 scores were improved within the CPAP group, CPAP use was associated with a decrease in PCS. The improvement in MCS was determined by the improvement in daytime sleepiness and depressive mood. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT00519597. CITATION: Wallström S, Balcan B, Thunström E, Wolf A, Peker Y. CPAP and health-related quality of life in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. J Clin Sleep Med. 2019;15(9):1311-1320.
RCT Entities:
STUDY OBJECTIVES: To determine the effect of continuous positive airway pressure (CPAP) treatment on health-related quality of life (HRQoL) in adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA). METHODS: This was a secondary outcome analysis of the RICCADSA trial, conducted in Sweden between 2005 and 2013. Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI] ≥ 15 events/h; Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires at baseline and after 12 months were included. Patients were randomized to CPAP (n = 102) or no CPAP (n = 104). The primary outcome was the between-group difference in absolute change in the SF-36 components. Within-group changes as well as variables associated with absolute change in the domains in the entire population were also tested. RESULTS: Mean SF-36 scores were similar at baseline, ranging from 44.9 ± 9.6 to 92.2 ± 15.8 in various domains, and between-group changes from baseline were not statistically significant at 1 year. There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group. The change in Physical Component Summary (PCS) was determined by female sex (beta coefficient -0.19, 95% confidence interval [CI] -7.25 to -0.98, P = .010), baseline AHI (beta coefficient -0.19, 95% CI -0.21 to -0.03, P = .009), CPAP use (h/night) (beta coefficient -0.16, 95% CI -0.93 to -0.06, P = .028), and acute myocardial infarction at baseline (beta coefficient 0.18, 95% CI 0.59 to 5.19, P = .014). Determinants of the change in MCS from baseline were change in the ESS score (beta coefficient -0.14, 95% CI -0.87 to -0.01, P = .054) and change in the Zung Self-rated Depression Scale scores (beta coefficient -0.33, 95% CI -0.58 to -0.24, P < .001). CONCLUSIONS: Assignment to CPAP treatment compared to no CPAP had no significant effect on HRQoL as measured by the SF-36 in adults with CAD and nonsleepy OSA. Although several components of the SF-36 scores were improved within the CPAP group, CPAP use was associated with a decrease in PCS. The improvement in MCS was determined by the improvement in daytime sleepiness and depressive mood. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT00519597. CITATION: Wallström S, Balcan B, Thunström E, Wolf A, Peker Y. CPAP and health-related quality of life in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. J Clin Sleep Med. 2019;15(9):1311-1320.
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