OBJECTIVE:To characterise long-term mask-type trajectories among patients receiving continuous positive airway pressure (CPAP) and assess their associations with CPAP nonadherence and treatment termination. METHODS:This real-world longitudinal cohort study included newly diagnosed adults treated with CPAP for more than 1 month. Patients had unrestricted access to 48 models across 4 mask types: nasal masks (NMs), oronasal masks (ONMs), and nasal-pillow masks (NPMs), with the latter subdivided into nasal-cradle masks (NCMs) and intranasal masks (INMs). Sequence analysis was used to identify mask trajectories, and multivariable models were used to estimate odds ratios (ORs) for CPAP nonadherence and treatment termination. RESULTS:Among 4675 patients, the median duration of CPAP treatment was 1.5 years (IQR, 0.7-2.8 years); 21.8% were nonadherent, and 26.1% terminated treatment. Adherent patients changed mask type less frequently than nonadherent patients and those who terminated treatment (43.7% vs 50.4% and 53.8%, respectively; p<.001). NM use decreased from 72.3% to 43.1%, whereas ONM use increased from 19.8% to 37.0%, INM use from 2.4% to 6.5%, and NCM use from 5.5% to 13.4%. Fifteen trajectories were identified. Compared with NM renewal, ONM and INM renewal were not associated with a higher risk of nonadherence or treatment termination, whereas NCM renewal was associated with CPAP termination (OR, 1.60; 95%CI, 1.04-2.47; p=.034). Switching from an initial NM to an INM (OR, 1.68; 95%CI, 1.18-2.39; p=.004), NCM (OR, 1.76; 95%CI, 1.26-2.45; p=.001), or ONM (OR, 1.31; 95%CI, 1.01-1.70; p=.046) was associated with CPAP termination. CONCLUSIONS:In routine clinical practice, NM, ONM, and INM renewal trajectories were comparable, whereas NCM renewal was associated with unfavourable outcomes. Switching from an NM to an ONM or NPM was associated with poorer CPAP use. NCMs and INMs should not be pooled under the general NPM category. TRIAL REGISTRATION:The SwitchAdene study is registered with the Health Data Hub under registration No. 19334378.
Objectif La coexistence de la bronchopneumopathie chronique obstructive (BPCO) et du syndrome d’apnées-hypopnées obstructives du sommeil (SAHOS) est connue sous le nom d’Overlap syndrome. Cette condition pourrait représenter un phénotype clinique distinct, présentant des réponses caractéristiques différentes à la ventilation non invasive (VNI) à domicile pour l’insuffisance respiratoire chronique hypercapnique. Cependant, les données actuelles restent limitées. Objectifs : cette analyse par modèle multi-états a estimé l’impact de la VNI à domicile sur les transitions entre trois états différents (sans/rétablissement d’exacerbation sévère, exacerbation sévère et décès) chez les patients overlap. Méthodes Les données sont issues de la base de données nationale de l’assurance maladie (SNDS) pour les personnes atteintes de BPCO âgées de ≥40 ans et ayant bénéficié d’au moins un remboursement de VNI entre 2015 et 2019. Les résultats entre le groupe « Overlap » et le groupe « BPCO » ont été comparés en utilisant un modèle de Cox et une analyse par pondération (IPTW) ajustés sur les caractéristiques initiales. Résultats Un total de 54 545 patients ont été inclus (âge médian : 70 ans, 51,2 % d’hommes). Les probabilités de transition d’une exacerbation sévère vers le décès (10 % vs. 22 %) et d’un état sans exacerbation sévère vers le décès (5 % vs. 18 %) étaient plus faibles dans le groupe « Overlap » que dans le groupe « BPCO ». Le taux de transition d’une exacerbation sévère vers un état sans exacerbation (rétablissement) était également plus élevé dans le groupe « Overlap ». Sous VNI, le taux de mortalité était réduit de 33 % chez les patients « Overlap » comparés à ceux atteints de BPCO sans SAHOS. Conclusion Ces données suggèrent que les patients « Overlap » bénéficient probablement davantage de la VNI à domicile au long cours que ceux atteints de BPCO. Ce constat souligne l’importance du dépistage du SAHOS chez les personnes atteintes de BPCO.
Background:Obstructive sleep apnoea (OSA) is often underdiagnosed, highlighting the need for scalable diagnostic alternatives. The SUNSAS study compared a new device for at-home diagnosis of OSA (artificial intelligence [AI]-supported analysis of mandibular jaw movements [MJM]) with polysomnography (PSG) for time to diagnosis and treatment, and patient-reported outcomes. Methods:This prospective, multicentre, randomised, controlled, open-label study was conducted in France (October 2021-October 2024). Adults aged 18-80 years with suspected OSA were randomised (1:1) to undergo diagnostic testing using MJM monitoring (Sunrise) or PSG. Primary endpoints were assessed using hierarchical testing: 1. daytime sleepiness (Epworth Sleepiness Scale [ESS] score) at 3 months post-diagnosis and time to diagnosis; 2. time to treatment; and 3. daytime sleepiness at 3 months post-randomisation. Secondary endpoints included quality of life (Short Form-36, Quebec Sleep Questionnaire), work productivity (Work Productivity and Activity Impairment questionnaire), and positive airway pressure therapy adherence at 3 months after treatment initiation. Findings:Of 849 participants randomised (58·7% male, median age 50 years, body mass index 28·0 kg/m2, apnoea-hypopnoea index 15·2/h), 774 received a diagnosis: 133 no OSA, 239 mild OSA, 220 moderate OSA, and 182 severe OSA. Median time to diagnosis (15 vs. 106 days) and to treatment initiation (50 vs. 124 days) were significantly shorter with MJM analysis versus PSG (both p < 0·01). MJM-based diagnosis was noninferior to PSG in reducing ESS at 3 months after diagnosis (-2·26 vs. -2·29; 95% confidence interval [CI] for difference -0·85, 0·79; p = 0·01), and superior at 3 months post-randomisation (between-group difference: -1·51 (95% CI -2·17, -0·85); p < 0·01). Secondary endpoints also favoured the MJM group. Interpretation:OSA diagnosis based on MJM monitoring with AI-supported analysis is noninferior to PSG in reducing daytime sleepiness at 3 months after diagnosis, while significantly accelerating time to diagnosis and treatment initiation, resulting in earlier improvement in daytime sleepiness. Funding:Sunrise, with support from the French Ministry of Health through the Forfait Innovation programme.
RATIONALE:Coexisting chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is known as overlap syndrome. This may represent a distinct clinical phenotype that shows different responses after being initiated on noninvasive ventilation (NIV) for hypercapnic chronic respiratory failure. However, current data remain scarce. OBJECTIVE(S):This study estimated the impact of overlap syndrome versus COPD without OSA on transitions between 3 states (without/recovery from severe exacerbation, severe exacerbation and death) in patients initiated on domiciliary NIV therapy. METHODS:Multistate model data came from the French national health insurance reimbursement system database for individuals with COPD aged ≥40 years and ≥1 NIV reimbursement in 2015-2019. Outcomes in the overlap syndrome and COPD without OSA groups were compared using a Cox model and inverse probability of treatment weighting analysis, adjusted for patient characteristics. RESULTS:Data from 54,545 patients were included (median age 70 years, 51.2% male). Probabilities of transitioning from severe exacerbation to death (10% vs. 22%) and without severe exacerbation to death (5% vs. 18%) were lower in the overlap syndrome versus COPD without OSA group. The rate of transition from severe exacerbation to without exacerbation/recovery was also higher in the overlap syndrome group. After NIV initiation, the mortality rate was 33% lower in people with overlap syndrome vs COPD without OSA. CONCLUSIONS:For people with COPD started on domiciliary NIV, those with overlap syndrome might benefit from NIV to a greater extent than those without OSA. This highlights the need for OSA screening in people with COPD.
Continuous Positive Airway Pressure (CPAP) telemonitoring is increasingly important in managing obstructive sleep apnea (OSA). The Apnea-Hypopnea Index reported by CPAP devices (AHIflow) is used as a key indicator of treatment effectiveness. However, discrepancies in AHIflow calculation rules between manufacturers may affect clinical decision-making. No prior studies have investigated whether manufacturers’ choices to exclude certain apnea-hypopnea events from the AHIflow calculation may influence the number of patients presenting an AHIflow alert. The aim of this proof-of-concept study was not to compare the manufacturers with each other, but to evaluate, for each manufacturer, how the different possible ways of calculating AHIflow influence the percentage of alert cases. We conducted a retrospective analysis of 13,764 CPAP-treated OSA patients monitored on October 2, 2023. AHIflow calculations were evaluated according to manufacturer-specific rules. When possible, we assessed the impact of excluding central hypopneas, events during major leaks, and/or ramp periods on the percentage of patients crossing the consensual AHIflow alert threshold of ≥ 10 events/h. We identified significant disparities in AHIflow calculations between manufacturers, which lead to significant differences in the number of patients flagged as being in an alert state. Excluding central hypopneas reduced the number of alert cases by 50
Introduction La ventilation non invasive (VNI) est devenue actuellement le traitement de référence de l’insuffisance respiratoire chronique avec hypoventilation alvéolaire. Bien que les principes du traitement soient les mêmes, l’adaptation des réglages est spécifique à chaque patient avec des recommandations qui divergent en fonction de l’étiologie. Cependant, il n’existe pas de données de vraie vie concernant les différences de paramètres en fonction du type d’insuffisance respiratoire chronique. L’objectif de ce travail est de comparer au sein de la cohorte descriptive ANTADIR GAVO2 les différences de prescriptions de paramètres entre les patients atteints de BPCO, les patients atteints de SOH, les patients atteints de SLA et les patients atteints de myopathies. Méthodes Étude multicentrique prospective et observationnelle. Les patients inclus dans la cohorte ont été séparés en 4 groupes : BPCO, SOH, SLA et myopathies. Les autres étiologies n’ont pas été incluses. Tous les paramètres ventilatoires ont été collectés et comparés (le type de ventilateur, le mode, et les paramètres ventilatoires). Résultats De mai 2015 à avril 2024, 3494 patients ont été inclus dans la cohorte ANTADIR GAVO2dans 19 centres et 2822 patients ont été inclus dans l’analyse (32 % (909) SLA, 34 % (959) BPCO, 27 % (750) SOH et 7 % (204) myopathes). Le critère d’indication de mise en route de la ventilation le plus fréquent sont les anomalies gazométriques (BPCO 71 %, SOH 74 %, SLA 33 %, Myopathies 43 %, p<0,005), sauf pour les patients atteints de SLA où les symptômes représentent le critère principal d’initiation (48 %). Une ventilation de niveau 1 était la plus fréquemment utilisée (80 % des patients atteints de BPCO, 76 % des patients atteints de SOH et 73 % des patients atteints de myopathies, mais seulement 14 % des patients atteints de SLA qui utilisaient préférentiellement une ventilation de niveau 3). Le mode S/T était le plus fréquemment instauré (86 % des patients atteints de BPCO, 82 % des SOH, 95 % des SLA et 90 % des myopathes). Enfin, les patients utilisaient en grande majorité un masque bucco-nasal (BPCO : 86 %, SOH 83 %, SLA 87 %, Myopathies 71 %). Concernant les réglages, l’aide inspiratoire était plus élevée chez les patients atteints de BPCO (12 [10–14] cmH2O) que dans les autres groupes (SOH 11 [8–14]), SLA 8 [7–10] et Myopathies 8 [6–10] cmH2O, p<0,005). La PEP était plus importante chez les patients atteints de SOH (8 [7–10] que dans les autres groupes (BPCO 6 [5–8], SLA 5 [4–8], Myopathies 6 [5–9], p<0,005) (Figure 1). Conclusion Cette cohorte prospective offre une analyse fiable et représentative de la réalité de la VNI à domicile en France. À l’heure où la pratique de la ventilation non invasive de domicile est en pleine mutation avec l’émergence de la télésurveillance et de la prise en charge en ambulatoire, ces données permettent de mieux appréhender les problématiques et les défis futurs pour l’organisation de sa prise en charge et la recherche clinique.
RATIONALE:Chronic obstructive pulmonary disease (COPD) is the most common indication for domiciliary non-invasive ventilation (NIV), but long-term outcomes data are limited. OBJECTIVE:This multistate model analysis estimated the impact of NIV therapy continuation versus cessation on transitions between three different disease states. METHODS:Model data came from the French national health insurance reimbursement system database for individuals aged ≥40 years with COPD and ≥1 NIV reimbursement in 2015-2019. MEASUREMENT AND MAIN RESULTS:Data from 49 503 patients started on NIV were included (median age 70 years, 51.2% male, median 1 exacerbation in the previous year). There were 80 361 severe exacerbations and 18 125 deaths (including 7805 in severe exacerbation). In multistate models, NIV continuation was associated with a significant reduction in transition to death, from severe exacerbation (HR 0.84, 95% CI 0.79 to 0.91) and without exacerbation (HR 0.88, 95% CI 0.83 to 0.93). NIV continuation versus cessation had no significant effect on transition between without exacerbation to severe exacerbation (HR 0.98, 95% CI 0.95 to 1.00) but was significantly associated with slower transition from severe exacerbation to without exacerbation (HR 0.87, 95% CI 0.84 to 0.89). CONCLUSION:This multistate model analysis found that the long-term use of domiciliary NIV was associated with a lower risk of transitions to death, but was not associated with a reduction in recovery time after severe exacerbation. These data highlight the potential mortality benefits of long-term domiciliary NIV in COPD and can be used as one piece of evidence to support evidence-based guideline recommendations.
Background: Continuous positive airway pressure (CPAP) effectiveness can be compromised by adverse effects. Despite its potential impact on adherence and sleepiness, aerophagia remains under-recognized and poorly characterized. This ancillary analysis of the InterfaceVent study aimed to identify risk factors for aerophagia in a large real-life cohort of CPAP-treated patients and to assess its association with both CPAP adherence and sleepiness. Methods: InterfaceVent was a prospective, real-life, cross-sectional study. Adults treated for at least 3 months with CPAP were included. Patients self-reported mask-related side effects using visual analogue scales. Aerophagia was defined as a dichotomous outcome based on patient-reported symptoms and CPAP non-adherence as mean nightly usage <4 h. Sleepiness was assessed using Epworth Sleepiness Scale (ESS). Results: A total of 1461 patients (median age 67 years (Q1-Q3; 60-74); 27.6% women) were included. Aerophagia was reported by 8.3% of participants. Compared to patients without aerophagia, those affected were younger, more frequently female, and had lower BMI. Patients with aerophagia reported a median ESS score of 7 (4-10) versus 5 (3-8) for patients without aerophagia (p < 0.001). CPAP usage was significantly lower in the aerophagia group (median 6.37 vs. 6.75 h/day; p = 0.001), whereas non-adherence, did not significantly differ between groups (10.7% vs. 7.5%; p = 0.20). Conclusions: This ancillary analysis of the InterfaceVent study highlights the burden of aerophagia in CPAP-treated patients and identifies modifiable and non-modifiable risk factors. Better recognition and management of this under-reported side effect may improve CPAP adherence and patient comfort. Trial registration: InterfaceVent is registered with ClinicalTrials.gov (NCT03013283). The first registration date is 23 December 2016.
Rationale:Suboptimal adherence limits the efficacy of Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea (OSA). Objective:To determine whether the Monthly Adherence Standard Deviation (MASD), that quantifies the variability in CPAP use during the baseline month (January 2021, at least the fourth month of treatment) provides predictive information about adherence, 6 and 12 months after baseline that would not be captured by the Monthly Adherence Mean (MAM) value alone. Methods:This retrospective analysis includes CPAP telemonitoring data from a population of 1612 patients. The overall population was randomly assigned to a construction (80 %) and test cohort (20 %) for internal validation. A threshold on baseline MASD was defined using a Receiver Operating Characteristic (ROC) curve. Results:A MASD threshold of 1.76 h was identified. Based on this threshold and the standard 4 h/day criterion applied to the MAM, patients were classified into four groups: high MAM/low MASD, high MAM/high MASD, low MAM/low MASD, and low MAM/high MASD. Significant differences were observed among the groups 6 and 12 months after baseline data. Six months after baseline, average MAM for each patient group in the test population were 6.84 ± 1.58, 5.66 ± 1.97, 1.27 ± 2.09, and 3.04 ± 1.90 h/day, respectively (p < 0.001); percentages of adherent patients were 91.4 %, 69.9 %, 6.25 %, and 13.9 % (p < 0.001). Similar patterns were found 12 months after baseline. Conclusions:MASD in CPAP adherence can distinguish between patients with different adherence behaviors 6 and 12 months after, capturing patterns not evident from MAM alone.
Background: A large number of symptomatic individuals with central sleep apnea (CSA) in clinical practice have an indication for adaptive servoventilation (ASV) therapy. Research Question: What are the effects of ASV therapy on sleep quality and patient-reported outcome measures in patients with CSA across a range of devices and indications? Study Design and Methods: This prospective multicenter observational cohort study was conducted in France and enrolled participants from June 2017 through February 2020. Adults with predominant CSA at diagnosis or OSA with central events not controlled with CPAP who had an indication for ASV were eligible. Participants attended clinic visits at baseline and after 1, 3, 6, and 12 months of follow-up. The primary end point was the change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 6-month follow-up (evaluated using a Wilcoxon signed-rank test on paired data). Results: We included 526 individuals (median age, 69 years; 88.2% male). The indication for ASV included CSA with cardiovascular or neurologic cause (38.4%), treatment-emergent CSA (36.1%), idiopathic CSA (14.1%), or drug-induced CSA (11.4%). At the 6-month follow-up, study participants were using ASV for a median of 6.1 h/night. The median change in the PSQI score from baseline to 6 months in the overall study population was -1 (interquartile range, -3 to 0; P < .001), with significant results across all indications for ASV except for drug-induced CSA, where the median change was similar to the overall results, but did not achieve statistical significance (-1 [interquartile range, -2 to 1]; P = .0866). Overall, 65% of participants showed a >= 1-point improvement in the PSQI. Interpretation: In this study, individuals with a clinical indication for ASV therapy experienced improved sleep quality during real-world treatment, regardless of which ASV device was used.
Objectif Si l’effet des saisons sur l’utilisation de la PPC a été récemment rapporté, aucune étude en vie réelle ne rapporte l’impact direct de la température sur l’utilisation à long terme de la PPC. Méthodes L’étude TempPPC est une étude de cohorte rétrospective en vie réelle. Entre le 1er octobre 2018 et le 21 septembre 2023, tous les patients adultes nouvellement traités et bénéficiant d’au moins 1 mois de PPC ont été inclus. Les données quotidiennes de température à 12h de la station météorologique la plus proche ont été attribuées à chaque patient et l’utilisation de la PPC a été recueillie à l’aide des données de télésurveillance. L’objectif principal de l’étude était d’étudier l’effet de la température sur l’utilisation de la PPC. Résultats Au total, 8151 patients (37,2 % de femmes, âge médian de 61 ans [IQ25–75 : 51–71]) et traités pendant une durée médiane de 1,6 an (0,7–3,0), ont été inclus dans l’étude (Fig. 1). La relation entre l’utilisation de la PPC et la température n’était pas linéaire, le meilleur modèle trouvant deux points de rupture à 18°C et 29°C. L’utilisation de la PPC diminue considérablement lorsque la température dépasse 29°C. Chaque augmentation de 1°C réduit l’utilisation de la PPC de 3,6 minutes. Par rapport à une température inférieure à 5°C, lorsque la température était supérieure à 30°C, l’utilisation de la PPC diminuait en moyenne de 30,3 (IC95 % : 29,3–31,4) minutes/jour, ce qui permettait d’atteindre la différence minimale cliniquement importante de 30 minutes chez 46,6 % des patients. Conclusion Chez les patients soumis à un traitement par PPC à long terme, une température supérieure à 29°C à 12h a un impact significatif sur l’utilisation de la PPC. Il serait intéressant de développer des mesures préventives, en informant le patient du risque d’une nuit avec une utilisation plus faible de la PPC en raison de la température surveillée pendant la journée.
The Alertapnée study followed 555 adults with obstructive sleep apnea treated with CPAP and found that the occurrence of Cheyne-Stokes respiration (CSR) was linked to a 14-fold increase in the risk of significant cardiac events (SCE) after one year. However, the progression and clinical significance of CSR episodes over time remain unclear. This ancillary study aimed to assess CSR progression and clinical outcomes during a second year of follow-up in 66 patients who had experienced at least one CSR episode in the first year. The study focused on the number of nights with CSR, percentage of CSR, SCEs. Results showed that 62 of 66 patients with CSR in the first year also experienced CSR in the second year, with a significant increase in the median number of CSR nights, particularly when CSR was related to cardiovascular conditions (37 vs. 19 nights, p = 0.006). Patients who experienced a SCE in year 2 had significantly more nights with CSR (median 48/90nights; IQR = 35) and a significantly greater mean percentage of CSR (median 13.8
Rationale: This study examinated variability in adherence—measured as variance in continuous positive airway pressure (CPAP) usage over the first two weeks—can classify patients based on future treatment quality (TQ). High TQ, defined as mean adherence > 4 hours/day, unintentional leaks < 24 L/min, and residual apnea-hypopnea index (AHI) < 5 events/hour, leads to better outcomes and fewer clinical interventions. Methods: We analyzed one month de-identified telemonitoring CPAP data of 24,253 CPAP treated Obstructive Sleep Apnea (OSA) patients (since at least four months) from a unique home care provider (ELIA Medical) database in January, June, and December 2021. Data included CPAP adherence, device-reported residual AHI, and 95th percentile unintentional leak rates from AirSense 10 (ResMed, Australia). A univariate k-means clustering approach (k=3) established thresholds using adherence variance from the first two weeks of January. These thresholds were applied to data from June and December. Percentage of patients achieving high-TQ, means of adherence (hours), leaks rate (L/min), AHI (events/h), nights without device use were calculated for each patients’ cluster in the following two weeks of the month. Statistical significance was tested with one-way ANOVA and chi-square tests. Figure depicts percentages of patients with adherence alerts (mean adherence < 4 hours/day), leaks alerts (mean leaks > 24 L/min), AHI alerts (mean AHI > 5 events/hour), and high-TQ by cluster in the second half of the month. Results: Clustering identified adherence variance thresholds at 3.82 h² and 10.09 h²: Cluster 1 (< 3.82 h²), Cluster 2 (3.82-10.09 h²), and Cluster 3 (> 10.09 h²). Patients in Cluster 1 were older ( ∼64 years old), mostly male (∼70%), with higher consistency (∼7 hours/night), higher high-TQ rates (∼57%), and fewer nights without device use (∼0.6 nights). Cluster 3 included younger patients (∼60 years old), fewer males (∼60%), lower consistency (∼5 hours/night), lower high-TQ rates (∼45%), and more nights without device use (∼3.7 nights). Differences in metrics across clusters were significant in all months, despite some overlap in mean adherence. Cluster 1 had significantly fewer alerts and higher high-TQ rates in the second half of the month compared to Clusters 2 and 3. Cluster 1 showed significant differences in adherence alerts and high-TQ percentages compared to other clusters. Conclusion: Analyzing adherence variance in the first two weeks assists in predicting high-TQ in subsequent weeks. This metric can identify patients with high adherence variance, enabling targeted interventions for better outcomes.
Background and objective The increasing number of patients requiring home noninvasive ventilation (HNIV) is a challenge for our healthcare system. Telemonitoring may be used to facilitate the management of HNIV patients. We aimed to assess the ability of telemonitoring algorithms to identify patients not adequately ventilated. Our secondary aim was to assess the consequences related to these algorithms, including costs. Methods 11 HNIV experts each provided an algorithm to identify patients with suboptimal ventilation. Each algorithm was tested using real-life data from a cohort of patients over a 90-day period. Inadequate HNIV was defined as the presence of at least one criterion amongst the following: uncontrolled hypoventilation, daily adherence <4 hday(-1), HNIV-related severe side-effect, or a residual event index >10h(-1). Results 100 patients were included in the cohort. According to our criteria, HNIV was considered as inadequate in 66 (66%) patients, without difference between underlying respiratory disease. Telemonitoring algorithms correctly classified patients in 65% (52-66) of cases. They had a global sensitivity of 78% (95% CI 37-95%), a specificity of 40% (95% CI 19-78%), a positive predictive value of 72% (95% CI 65-77%) and a negative predictive value of 45% (95% CI 37-51%). Applying telemonitoring algorithms resulted in median (interquartile range) 127 (84-238) alerts across the study population with a median cost increase of EUR 2064 (952-6262). Conclusion Telemonitoring algorithms have poor diagnostic performances in identifying inadequately ventilated patients. They increase workload for healthcare workers and costs.
BACKGROUND AND OBJECTIVE:High treatment quality, defined by mean adherence >4 hours per day, unintentional leaks <24 L/min and a residual Apnoea-Hypopnoea Index <5 events per hour, is associated with better outcomes. Adherence variance may reflect behaviour linked to better treatment quality. This study aimed to assess whether monthly adherence variance is associated with improved treatment quality in patients treated with non-invasive ventilation (NIV) for more than 4 months. METHODS:E-QualiNIV is a retrospective study evaluating treatment quality in 511 telemonitored patients with chronic respiratory failure, observed from 15 April to 31 October 2023. The study followed three steps: (1) hierarchical clustering based on individual adherence variance; (2) assessing whether monthly adherence variance in the preceding month predicted the proportion of alerts in the subsequent month and (3) evaluating treatment quality based on the number of months with low adherence variance. RESULTS:Cluster 1, consisting of patients with adherence variance below 3, had a significantly higher proportion (57.93%) of patients achieving high-quality treatment compared with other clusters (43.1% for cluster 2 and 46.4% for cluster 3) (p=0.035). Patients with a low adherence variance in the preceding month were more likely to achieve high-quality treatment in the following month (except for May, significant differences every month from p=0.04 to p<0.01). Those with 6 or more months of low adherence variance had a significantly higher probability of receiving high-quality treatment over the entire period (coefficient: 0.2649, p value: 0.0028) compared with those who did not (non-significant). CONCLUSION:The E-QualiNIV study demonstrates that low adherence variance is associated with high-quality treatment and serves as a prognostic indicator of treatment stability and alert occurrence in the subsequent month.
Rationale: Positive airway pressure therapy modalities in obesity hypoventilation syndrome (OHS) are still debated. Objectives: To describe health trajectories before and after starting noninvasive ventilation (NIV) and compare post-NIV outcomes between groups with different pre-NIV trajectories. Methods: Data came from the French national health insurance reimbursement database for individuals with OHS and one or more NIV prescriptions between January 1, 2015, and December 31, 2019. Health trajectory clusters were determined using mixture models that were graphically represented by time sequence analysis. Results: Data from 8,842 individuals were analyzed (59.7% had coexisting obstructive sleep apnea, 64% had one or more comorbidities). Median follow-up was 3.1 years. Cluster 1 (n = 5,853; 66.2%) started NIV while stable after pulmonary function testing, arterial blood gas (ABG) analysis, and sleep studies; 23.7% underwent bariatric surgery around NIV initiation. One-year therapy termination and mortality rates were 51.8% and 5.5%, respectively. Cluster 2 (n = 757; 8.6%) started NIV during or immediately after one or more acute intensive care unit hospitalizations in the previous year; 1-year NIV termination and mortality rates were 34.3% and 9.1%, respectively. Cluster 3 (n = 526; 5.9%) had NIV initiation after a sleep study, pulmonary function testing/arterial blood gas analysis, and approximately 3 months of continuous positive airway pressure; 1-year therapy termination and mortality rates were 23.0% and 2.1%, respectively. In cluster 4 (n = 1,706; 19.3%), long-term continuous positive airway pressure preceded the switch to NIV after reassessment in ambulatory care; 1-year therapy termination and mortality rates were 18.4% and 4.5%, respectively. Conclusions: These novel data highlight marked heterogeneity in OHS and use of positive airway pressure therapies, which significantly impacts outcomes.
BACKGROUND:Although seasonal variations in CPAP-usage are often attributed to changes in temperature, no real-world study has evaluated the influence of temperature on long-term CPAP-usage. METHODS:The TempCPAP study is a retrospective real-life cohort study. Adult patients newly treated and undergoing at least 1 month of CPAP were included. Daily 12-PM temperature data from the nearest weather station was assigned to each patient and CPAP-usage was collected using telemonitoring data. The primary objective of the study was to investigate the relationship between temperature and CPAP-usage. RESULTS:8151 patients (37.2 % women) with a median age of 61 (IQ25-75: 51-71) years, initial AHI of 36 (29-49.6) events/h, treated for a median duration of 1.6 years (0.7-3.0), and with a CPAP-usage of 5.4 (3.0-6.9) h/day were included. The relationship between CPAP-usage and temperature was non-linear. The best model found two breakpoints at 18 °C and 29 °C. CPAP-usage dropped drastically when the temperature exceeded 29 °C, as each 1 °C increase was associated with a 3.6-min reduction in CPAP-usage. Compared to temperatures of less than 5 °C, temperatures above 30 °C resulted in a mean reduction in CPAP-usage of 30.3 (confidence interval (CI95 %): 29.3-31.4) minutes/day, achieving the minimal clinically important difference of 30 min in 46.6 % of patients. CONCLUSION:In patients undergoing long-term CPAP therapy, temperatures over 29 °C at 12-PM were associated with reduced CPAP-usage. TRIAL REGISTRATION:TempCPAP is registered with health data hub (n°20475117).
RATIONALE:Telemonitoring has shown benefits during the initiation of home non-invasive ventilation (NIV) but evidence is lacking regarding its use during follow-up. A French national telemonitoring programme incorporating remote support and therapeutic education is designed to improve patient pathways and reduce healthcare resource utilisation. This study investigated the impact of the telemonitoring programme versus usual follow-up on the effectiveness of home NIV. METHODS:The prospective, multicentre, open-label eVENT trial enrolled adults recently started on home NIV. Participants were randomised to the telemonitoring or usual follow-up group. In the telemonitoring group, a CE-marked algorithm generated alerts based on teletransmitted ventilator data. Specialised nurses managed alerts and provided therapeutic education. The primary outcome was mean nocturnal transcutaneous carbon dioxide level (PtCO2) on NIV after 6 months. RESULTS:56 patients were randomised and 53 were analysed (telemonitoring: n=27, usual follow-up: n=26). At 6 months, mean PtCO2 did not differ significantly between the telemonitoring and usual follow-up groups (42.1±6.1 vs 43.9±6.4 mm Hg; p=0.352) but mean room air partial arterial carbon dioxide pressure (PaCO2) was significantly lower in the telemonitoring versus usual follow-up group (41.7±6.8 vs 46.2±3.5 mm Hg; p=0.003). The proportion of participants without diurnal or nocturnal hypercapnia at 6 months was 82.6% with telemonitoring and 27.3% with usual follow-up (p<0.001). Compared with usual follow-up, the telemonitoring group had greater NIV use, more days with NIV usage ≥4 hour and less non-intentional leaks. CONCLUSIONS:In patients on home NIV, PtCO2 was similar with telemonitoring and usual follow-up, but PaCO2 levels and the quality of ventilatory support were significantly better with telemonitoring. TRIAL REGISTRATION NUMBER:NCT04615078.