ResMed (Germany)

BackgroundAlthough adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL).MethodsThis report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up.ResultsThe registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea­–hypopnoea index was 48±23 events·h−1 (≥30 events·h−1 in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10).ConclusionThe most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.

AimsHeart failure with preserved ejection fraction (HFpEF) is a condition with increasing prevalence. Sleep‐disordered breathing (SDB) is an important co‐morbidity in HFpEF. The SchlaHF‐XT registry evaluated the sex‐specific prevalence and predictors of SDB, including obstructive (OSA) and central sleep apnoea, in patients with HFpEF compared with heart failure with mildly reduced (HFmrEF) or reduced (HFrEF) ejection fraction.Methods and resultsConsecutive adults with chronic heart failure treated according to current guidelines were enrolled. The presence of moderate‐to‐severe SDB (apnoea–hypopnoea index ≥15/h) was determined using Type 3 polygraphic devices. Of 3289 patients included, 2032 had HFpEF, 559 had HFmrEF, and 698 had HFrEF, of whom 34, 21, 23, and 42%, respectively, were female. Prevalence of SDB in HFpEF was high, but significantly lower than in HFmrEF or HFrEF (36% vs. 41 and 48%, respectively). Rates of SDB in males and females were 41 and 28% in HFpEF, 44 and 30% in HFmrEF, and 50 and 40% in HFrEF. The proportion of males and females with SDB who had OSA was significantly greater in those with HFpEF vs. HFrEF. Male sex, older age, higher body mass index, and New York Heart Association functional Class III/IV were significant predictors of moderate‐to‐severe SDB in HFpEF patients.ConclusionsPrevalence of SDB in HFpEF was high, but lower than in patients with HFmrEF or HFrEF. Moderate‐to‐severe SDB occurred more frequently in males than in females across the whole spectrum of heart failure. In both sexes, the proportion of OSA in SDB patients with HFpEF was higher than in those with HFrEF.

Introduction: The prevalence of type 2 diabetes mellitus (T2DM) in young adults has increased considerably in the pastdecade. Evidence shows that lifestyle modification programs such as the Diabetes Prevention Program (DPP) areeffective in improving health behaviors and lowering the risk of diabetes. DPP follow-up studies have found that a lackof retention can reduce the effectiveness of such programs. Adding a positive social reinforcement platform is a novelstrategy to provide educational resources to facilitate lifestyle changes. However, evidence regarding the effect ofpositive social reinforcement as a theory-based strategy to prolong retention within the DPP is limited. The current studyprotocol aims to evaluate the efficacy of the online Prevent Diabetes® Program, including a Positive Inter@ctiOn forumon time-to-attrition from the DPP among college students at high risk for T2DM.Methods: This study protocol is a phase 3, multicenter, double-blinded, cluster-randomized, superiority, controlled trialconducted in West Virginia, Alabama, and Mississippi. Four hundred eigclthty college students will be centrallyrandomized in a cluster-wise 1:1 ratio to the online Prevent Diabetes® Program integrated with the Positive Inter@ctiOnforum or to the online Prevent Diabetes® Program alone for 12 months. The primary outcome is time-to-attrition fromthe DPP.Discussion: Successful completion of the study will provide valuable information on whether implementing theory-basedhealth behavior strategies can improve the retention of participants in the online DPP and contribute to enhancing DPPeffectiveness.

Background: ASV is an effective therapy to control central sleep apnea (CSA). However, little is known about the effects of ASV on quality of life (QoL) and sleep in different patient populations. Objectives: To test the effects of ASV therapy on disease specific QoL (Functional Outcomes of Sleep Questionnaire, FOSQ) and reported quality of sleep (Pittsburgh Sleep Quality Index, PSQI). Methods: READ-ASV is a multi-center, prospective registry including patients with newly initiated ASV therapy in routine clinical practice. Changes in FOSQ and PSQI from baseline to follow-up (12±3 months) were investigated in an intermediate analysis. Results: At baseline, ASV-patients (66±12 years, 13% female, body-mass index of 33±7 kg/m²) had a diagnostic apnoea-hypopnea index of 52±24/h (central apneas/total apneas 29%). The type of sleep disordered breathing at baseline were predominant CSA (39%), co-existing CSA and OSA (35%), OSA (18%) and unknown (8%, presentation with positive airway pressure therapy). The FOSQ total score significantly improved on ASV-therapy (15.8 ± 3.3 to 16.4 ± 3.2; p=0.04). The PSQI total score improved from 8.2 ± 4.6 at baseline to 6.1 ± 3.6 at follow-up (p Conclusions The ongoing READ-ASV registry shows modest improvements in a diverse population of ASV-treated patients in disease specific QoL and sleep quality. Specific subgroups will be studied in a larger sample.

Some patients (pts) complain of high pressure with PAP devices that may contribute to poor sleep quality. Aim of this multicenter study was to assess pts who benefited from a switch to bilevel PAP therapy (AirCurve10 VAuto). 3 month FU results are presented here. <b>Methods:</b> 43 pts treated with PAP were enrolled in the study. Diagnostic PG data, PAP variables, VAuto settings, quality of sleep (PSQI), fatigue, sleepiness (ESS) &amp; side effects were collected. At 3 months device data, PSQI, side effects &amp; pts satisfaction were collected. Paired analysis are performed to compare variables change. <b>Results:</b> Population: mean Age:64±10.8y, BMI:30.7±5.8 kg/m², 27 men (66%), 21 HTA (53%), diag AHI: 46.6±19.5, 34 pts treated with APAP (85%). PAP mean pressure: 11.6± 2.3 cmH20, 95% pressure: 13.2 ±2.1 cmH20, mean leaks: 5.5±10.5 L/min, 95% leaks: 18.2±15.4 L/min. residual AHI: 4.7±3.3, daily usage: 5.6±2.0 h/d, % nights with usage&gt;4h: 79±27%. VAuto mean EPAP: 8.3±2.6 cmH20, 95%: 10.3±2.8 cmH20 was reduced vs PAP (p&lt;0.001). mean Leaks : 1.9±3.9 L/min, 95%: 3.6±9.5 L/min was reduced vs PAP (p=0.013). IPAP (mean: 12.4 ± 2.8 cmH20, 95%: 14.4 ± 2.8 cmH20). No significant difference between PAP &amp; VAuto regarding daily usage, residual AHI. PSQI was improved (p=0.023) as ESS &amp; pichot (NS). Side effects were improved with VAuto: dry mouth (63 vs. 41% pts, p=0.033) &amp; aerophagia (50 vs 19% pts, p=0.003). 90% of pts preferred VAuto to their previous PAP, 94.4% wanted to continue with the VAuto. <b>Conclusion:</b> Patients short-term quality of sleep, satisfaction and comfort were increased after a switch from PAP to VAuto, likely due to EPAP decrease and leaks reduction.

Two custom-made mandibular repositioning device (MRD) designs were evaluated in a randomized cross over study: Computer aided design (CAD)/computer-aided manufacturing (CAM) or nonCADCAM processes. Study aim was to assess the impact of two MRD on OSA patient’s oropharyngeal airway volume (OV). Methods: 12 OSA patients randomized in the study. A polygraphy, a dental cone beam computed tomography exam were performed at baseline. Patients were treated 1 month with each MRD. At FU, a polygraphy and a cone beam were performed. Results: Age: 53±9 y, BMI: 27±4 kg/m², mean apnea hypopnea index (AHI): 22±7.8 /h, mean oxygen desaturation index (ODI): 19±6 /h, mean occlusal vertical dimension (OVD): 64±5 mm, mean oropharyngeal airway volume: 20 007±4442 mm3. At FU: OV improved significantly with Narval CADCAM (27 732±7381 mm3 (p=0.008)) vs Narval non-CADCAM (23812 ± 9538 mm3, (p=NS)). AHI with CADCAM and nonCADCAM decreased respectively to 11±6.3 evt/h (p=0.005) and 14.7±12 evt/h (p=0.083). ODI with CADCAM and nonCADCAM decreased respectively to 12±7 (p=0.011) and 14±13 (p=0.074). Occlusal Vertical Dimension OVD was significantly smaller with CADCAM (73±5 mm) than non-CADCAM (75±5mm), p=0.003. Multivariate linear regression revealed a significant link between the difference of OVD variation and OV changes in the 2 MRD (p=0.018) Conclusion: CADCAM MRD increased OV more efficiently than non-CADCAM device. This difference is likely due to a smaller OVD.

The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.