Helder Novais Bastos1,2,3, Ana Verónica Cardoso4, Ana Sofia Castro5, Rita Gomes6, Tiago Pinto4, Anabela Marinho4, Maria Sucena4, João Almeida4, Marta Drummond4,7, João Carlos Winck4,7,8. 1. Pulmonology Department, Centro Hospitalar de São João, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal. helder.bastos@hsjoao.min-saude.pt. 2. Life and Health Sciences Research Institute (ICVS), School of Health Sciences, University of Minho, Minho, Braga, Portugal. helder.bastos@hsjoao.min-saude.pt. 3. ICVS/3B's - PT Government Associate Laboratory, Braga, Guimarães, Portugal. helder.bastos@hsjoao.min-saude.pt. 4. Pulmonology Department, Centro Hospitalar de São João, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal. 5. Pulmonology Department, Centro Hospitalar Gaia-Espinho, Vila Nova de Gaia, Portugal. 6. Pulmonology Department, Hospital Sousa Martins, Guarda, Portugal. 7. Faculty of Medicine, University of Porto, Porto, Portugal. 8. Linde AG, Linde Healthcare, Pullach, Germany.
Abstract
PURPOSE:Auto-titrating continuous positive airway pressure (APAP) devices were developed to improve treatment efficacy and compliance in patients with obstructive sleep apnoea syndrome (OSAS). Since there are insufficient data on the optimal pressure range setting, we aimed to compare the adherence, efficacy and tolerability of treatment with high-span versus low-span APAP. METHODS:Seventy-sixnewly diagnosed OSAS patients fulfilling the treatment criteria were randomised to receive high-span (HS, range 4-15cmH2O, n = 38) or low-span (LS, range 8-12cmH2O, n = 38) APAP. Patients were assessed at 1 and 3 months. RESULTS:Median Epworth sleepiness scale (ESS) was 13 (IQR, 6-16) and median apnoea-hypopnoea index (AHI) was 35.9 (IQR, 27.6-56.3). There were no significant differences in baseline demographic and clinical characteristics between groups. Overall, no significant differences were found at the first month assessment. After 3 months of therapy, we found again no differences in residual AHI or ESS. However, the group HS proved less adherent than group LS, respectively, with median 87 % (IQR, 60.5-97.5) versus 94 % (IQR, 80.0-98.3) of the nights using ≥4 h (P = 0.014) and mean (±SD) usage 5.7 ± 1.6 versus 6.4 ± 1.2 h/night (P = 0.049). The group HS reported more frequently nasal congestion, excessive oronasal dryness and nocturnal awakenings of at least moderate intensity, the latter with statistical significance (P = 0.005). CONCLUSIONS: Both pressure ranges appear to be equally effective to correct AHI and to improve symptoms. Though, patients with high-span APAP were less compliant to treatment, raising issues about the tolerability of wide pressure range settings of these devices.
RCT Entities:
PURPOSE: Auto-titrating continuous positive airway pressure (APAP) devices were developed to improve treatment efficacy and compliance in patients with obstructive sleep apnoea syndrome (OSAS). Since there are insufficient data on the optimal pressure range setting, we aimed to compare the adherence, efficacy and tolerability of treatment with high-span versus low-span APAP. METHODS: Seventy-six newly diagnosed OSAS patients fulfilling the treatment criteria were randomised to receive high-span (HS, range 4-15cmH2O, n = 38) or low-span (LS, range 8-12cmH2O, n = 38) APAP. Patients were assessed at 1 and 3 months. RESULTS: Median Epworth sleepiness scale (ESS) was 13 (IQR, 6-16) and median apnoea-hypopnoea index (AHI) was 35.9 (IQR, 27.6-56.3). There were no significant differences in baseline demographic and clinical characteristics between groups. Overall, no significant differences were found at the first month assessment. After 3 months of therapy, we found again no differences in residual AHI or ESS. However, the group HS proved less adherent than group LS, respectively, with median 87 % (IQR, 60.5-97.5) versus 94 % (IQR, 80.0-98.3) of the nights using ≥4 h (P = 0.014) and mean (±SD) usage 5.7 ± 1.6 versus 6.4 ± 1.2 h/night (P = 0.049). The group HS reported more frequently nasal congestion, excessive oronasal dryness and nocturnal awakenings of at least moderate intensity, the latter with statistical significance (P = 0.005). CONCLUSIONS: Both pressure ranges appear to be equally effective to correct AHI and to improve symptoms. Though, patients with high-span APAP were less compliant to treatment, raising issues about the tolerability of wide pressure range settings of these devices.
Authors: Oliver Senn; Thomas Brack; Felix Matthews; Erich W Russi; Konrad E Bloch Journal: Am J Respir Crit Care Med Date: 2003-10-02 Impact factor: 21.405