European Respiratory Journal最新文献

Rationale: Adherence to Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnoea (OSA) continues to be low with high termination rates. Alternative therapies to CPAP are needed.

Objectives: To compare objective adherence to CPAP and Mandibular Advancement Splints (MAS) and to evaluate their effectiveness. Additionally, to identify treatment usage patterns and the clinical effectiveness of having both therapies.

Methods: This multi-center, double-randomized, three-phase trial (titration/cross-over/observation) was conducted at three Canadian universities. Eligible participants were treatment-naïve with mild to severe OSA.

Measurements and main results: Primary outcome was objectively measured adherence (hours/night) during cross-over phase. Secondary outcomes included efficacy during cross-over phase; adherence during observational phase; patient-centered outcomes, blood pressure and side-effects during cross-over and observational phases. Duration of cross-over and observational phases were 2.5 and 6 months respectively.Eighty-one participants were enrolled in the first randomization. Seventy-nine entered the adaptation/titration phase [mean age (sd); 52·3 (10·8) years, 58 males], 73 entered the cross-over phase (included in the intention-to-treat analysis) and 64 completed the observation phase. Mean objective adherence over 1-month, MAS showed higher adherence than CPAP, 6·0 versus 5·3 h/night (difference= 0·7 h/night, 95% CI: 0·3-1·2 h, p<0·001). Mean CPAP-MAS difference (95% CI) in efficacy of 10·4 (7·8-13) events/hour, p<0·001. During the observation phase 55% (35/64) of participants chose to alternate therapies. All treatments led to substantial improvement in patient-centered outcomes.

Conclusions: Despite the higher efficacy of CPAP and higher adherence to MAS, both demonstrate comparable clinical effectiveness on patient-centered outcomes. Having both CPAP and MAS can improve long-term management of OSA.

Background: The "Baveno classification" replaced the apnoea-hypopnoea index (AHI) with symptoms and comorbidities for treatment indication in obstructive sleep apnoea (OSA). This study evaluates a modified Baveno classification which adds a validated cardiovascular disease (CVD) risk score and acknowledges severe breathing disturbances.

Method: OSA patients from the European Sleep Apnoea Database (ESADA) were retrospectively allocated into CVD risk groups 1-3 based on the SCORE2 risk prediction model and European Society of Cardiology guidelines. AHI ≥30 events·h^-1 conferred strong treatment indication. When AHI was <30 events·h^-1, symptoms and CVD risk dictated allocation to the weak, intermediate or strong treatment indication group. Changes in Epworth Sleepiness Scale (ESS) score and office systolic blood pressure (SBP) at follow-up (12-24 months) under positive airway pressure (PAP) were assessed.

Results: 8625 patients were analysed (29% female; median (interquartile range) age 56 (49-64) years and body mass index 31.9 (28.4-36.3) kg·m^-2). Treatment indication was weak in 501 (6%), intermediate in 2085 (24%) and strong in 6039 (70%). There was a continuous increase in age, SBP, C-reactive protein and glycosylated haemoglobin from weak to strong (p<0.001). PAP prescription increased from 52% to 64% to 93% (weak to strong; p<0.001). The change in ESS score was -2, -4 and -5, respectively (p<0.001). Reductions of ≥3 mmHg median SBP occurred when AHI was ≥30 events·h^-1 and in symptomatic patients with CVD risk levels >1 when AHI was <30 events·h^-1.

Conclusion: This analysis provides supporting evidence for the key role of CVD risk assessment and severe breathing disturbances in the identification of OSA patients most likely to benefit from treatment.