RESUMEN
Background. Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H2) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods: We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results: A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H2 group, 46.1% in the H2 group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H2 group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions: HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.
RESUMEN
INTRODUCTION: Long-term adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea remains suboptimal and low adherence increases healthcare costs. This study investigated relationships between CPAP adherence and the intensity of support provided by homecare providers after implementation of telemonitoring and pay-for-performance reimbursement for CPAP in France. METHODS: Adults who started CPAP in 2018/2019, used telemonitoring, and had ≥1 year of homecare provider data were eligible. The main objective was to determine associations between CPAP adherence at 1 month (low [<2h/night], intermediate [2 to <4h/night], high [≥4h/night]) and the number/type of homecare provider interactions (home visits, phone calls, mask change) during the first year. RESULTS: Eleven thousand, one hundred sixty-six individuals were included (mean age 59.8±12.7 years, 67% male). The number of homecare provider interactions per person increased significantly as 1-month CPAP usage decreased (7.65±4.3, 6.5±4.0, 5.4±3.4 in low, intermediate and high adherence groups; p<0.01). There was marked improvement in device usage over the first 5-6 months of therapy in the low and intermediate adherence subgroups (p<0.05 after adjustment for age, sex, initial CPAP adherence, and number of interactions). After adjustment for age, sex and 1-month adherence, having 3-4 interactions was significantly associated with better 1-year adherence (odds ratio 1.24, 95% confidence interval 1.05-1.46), while having >7 interactions was significantly associated with worse 1-year adherence. CONCLUSIONS: The telemonitoring/reimbursement scheme in France had a positive impact on CPAP adherence and facilitated a more personalised approach to therapy management, focusing resources on patients with low and intermediate adherence.
RESUMEN
INTRODUCTION: Monitoring changes in symptoms over time during long-term nocturnal home non-invasive ventilation (NIV) using patient-reported outcome measures is crucial. This study aimed to identify factors associated with changes in the S3-NIV total score, its two domains ("respiratory symptoms" and "sleep and NIV-related side effects") and individual item responses. METHODS: We conducted a retrospective, longitudinal data analysis of a cohort of adults with chronic respiratory failure treated with NIV. Data were obtained from a French homecare provider. Multivariate linear and multinomial ordinal mixed effect models were used to identify factors associated with changes in S3-NIV scores over time. RESULTS: Median follow-up was 2 years for 2135 participants. Each participant completed a median of five S3-NIV questionnaires; totaling 11,359 analyzed questionnaires. Type of respiratory condition, sex, age and time since NIV initiation were associated with change in S3-NIV score over time. NIV adherence was not associated with total S3-NIV score but high adherence was associated with more severe respiratory symptoms and an improvement in sleep and NIV-related side effects during the follow-up. Intensity of pressure support was associated with a lower total S3-NIV score and more side effects. Face masks and supplemental oxygen were associated with a lower S3-NIV total score. CONCLUSION: Changes in S3-NIV scores over time are associated with the individual's characteristics and NIV settings. Analysis of the two domains and individual items of the S3-NIV could increase understanding of the difficulties experienced by people on NIV.
Asunto(s)
Servicios de Atención de Salud a Domicilio , Ventilación no Invasiva , Insuficiencia Respiratoria , Humanos , Masculino , Femenino , Insuficiencia Respiratoria/terapia , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , Enfermedad Crónica , Estudios Longitudinales , Medición de Resultados Informados por el Paciente , Cooperación del Paciente , Factores de Tiempo , Anciano de 80 o más Años , Adulto , FranciaRESUMEN
INTRODUCTION: Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy. METHODS AND ANALYSIS: This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants. ETHICS AND DISSEMINATION: The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites. TRIAL REGISTRATION NUMBER: NCT05385302.
Asunto(s)
Síndromes de la Apnea del Sueño , Apnea Obstructiva del Sueño , Adulto , Humanos , Presión de las Vías Aéreas Positiva Contínua , Estudios Prospectivos , Calidad de Vida , Apnea Obstructiva del Sueño/terapia , Instituciones de Atención Ambulatoria , Estudios Observacionales como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
Aim: To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. Methods: We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. Results: Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6-10.5] compared to pre-AHCL initiation, P < 0.001), HbA1c 7.1% ± 0.7% (-0.5%; 95% CI [-0.6 to -0.4]; P < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [-2.0; 0.0], P < 0.001), and time above range 24.8% ± 10.9% (-7.3%; 95% CI [-8.8 to -5.7]; P < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%, P < 0.001) and TIR >70% (59.0% vs. 29.5% P < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. Conclusion: After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control.
Asunto(s)
Automonitorización de la Glucosa Sanguínea , Glucemia , Diabetes Mellitus Tipo 1 , Control Glucémico , Hipoglucemiantes , Sistemas de Infusión de Insulina , Insulina , Humanos , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/sangre , Estudios Retrospectivos , Masculino , Femenino , Francia , Adulto , Glucemia/análisis , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/administración & dosificación , Control Glucémico/métodos , Insulina/administración & dosificación , Insulina/uso terapéutico , Persona de Mediana Edad , Hemoglobina Glucada/análisis , Resultado del Tratamiento , Hipoglucemia/prevención & control , Hipoglucemia/inducido químicamenteRESUMEN
BACKGROUND: Mucociliary clearance is a cornerstone of the management of people with non-cystic fibrosis bronchiectasis (NCFB). SIMEOX, an innovative device, could facilitate autonomous airway clearance, but its use requires specific training. We hypothesised that telecare would be an effective means to train people with NCFB in the handling of device and to monitor and promote device adherence. OBJECTIVES: (1) To evaluate frequency of use of the SIMEOX for 10 weeks after telecare training. (2) To assess user satisfaction and clinical efficacy of the SIMEOX+telecare. METHODS: Multicentre, prospective, pilot study in adults with NCFB. A SIMEOX was provided to each participant at inclusion. Physiotherapists performed telecare sessions the first 2 weeks (3-5 sessions) for device training and every 10 days to reinforce motivation and provide technical support. RESULTS: 22 individuals were included, 21 analysed (38% male; mean±SD age 53±18 years; Bronchiectasis Severity Index 6.6±3.5). Fourteen participants (66.7%; 95% CI 43.1% to 84.5%) performed ≥3 SIMEOX sessions/week (self-reported adherence, primary outcome). Median (Q1; Q3) number of self-reported sessions/week for the whole group was 3.7 (1.8; 5.7). Adherence including web registration was 80.9%. At week 12, participant satisfaction rating was 9.0 (7.9; 10.0) on a 10-point visual analogue scale; respiratory function did not change but quality of life improved (COPD Assessment Test score -4.7, 95% CI -7.7 to -1.6, p=0.023; St Georges Respiratory Questionnaire -5.8, 95% CI -10.8 to -0.9, p=0.005). CONCLUSION: Adherence to and satisfaction with the SIMEOX airway clearance device supported by telecare were high in people with NCFB. The clinical efficacy needs to be confirmed in a randomised controlled trial. TRIAL REGISTRATION NUMBER: NCT04742270.
Asunto(s)
Bronquiectasia , Fibrosis Quística , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Bronquiectasia/terapia , Estudios de Factibilidad , Proyectos Piloto , Estudios Prospectivos , Calidad de VidaRESUMEN
Insulin pump therapy improves glycaemic control in individuals with type 2 diabetes. However, it may be associated with weight gain. AIM: To test the effectiveness of a six-month dietary and physical activity intervention, compared to usual care, on weight gain prevention after initiation of insulin pump. METHODS: Multicentre randomized, controlled trial of 54 individuals. Primary endpoint was between group difference in weight gain at six-months. RESULTS: Weight gain after 6 months of insulin pump treatment did not differ between groups: mean 3.2 (3.9) kg in the control group and 3.9 (3.8) kg in the intervention group, (p = 0.56). HbA1c improved without difference between groups. Post-hoc multivariate analysis of all participants found that weight gain was independently associated with younger age, active smoking, and the magnitude of HbA1c reduction. A 1 % decrease in HbA1c was associated with an increase of 0.94 kg [95 % Confidence Interval 0.47; 1.41], p < 0.001. CONCLUSIONS: Treatment intensification by insulin pump therapy in patients with type 2 diabetes is effective to improve glycaemic control. A gain of about 1 kg per 1 % drop in HbA1c can be expected after insulin treatment intensification. This weight gain was not prevented by a home-base, individualized, 6-months lifestyle intervention program.
Asunto(s)
Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/prevención & control , Diabetes Mellitus Tipo 2/inducido químicamente , Hipoglucemiantes , Insulina , Hemoglobina Glucada , Aumento de Peso , Estilo de VidaRESUMEN
INTRODUCTION: Home noninvasive ventilation (NIV), targeting a reduction of carbon dioxide with a combination of sufficient inspiratory support and backup-rate improves outcomes in patients with chronic obstructive pulmonary disease. The aim of this systematic review with individual participant data (IPD) meta-analysis was to evaluate the effects of intensity of home NIV on respiratory outcomes in individuals with slowly progressive neuromuscular (NMD) or chest-wall disorders (CWD). METHODS: Controlled, non-controlled and cohort studies indexed between January-2000 and December-2020 were sought from Medline, Embase and the Cochrane Central Register. Outcomes were diurnal PaCO2, PaO2, daily NIV usage, and interface type (PROSPERO-CRD 42021245121). NIV intensity was defined according to the Z-score of the product of pressure support (or tidal volume) and backup-rate. RESULTS: 16 eligible studies were identified; we obtained IPD for 7 studies (176 participants: 113-NMD; 63-CWD). The reduction in PaCO2 was greater with higher baseline PaCO2. NIV intensity per se was not associated with improved PaCO2 except in individuals with CWD and the most severe baseline hypercapnia. Similar results were found for PaO2. Daily NIV usage was associated with improvement in gas exchange but not with NIV intensity. No association between NIV intensity and interface type was found. CONCLUSION: Following home NIV initiation in NMD or CWD patients, no relationship was observed between NIV intensity and PaCO2, except in individuals with the most severe CWD. The amount of daily NIV usage, rather than intensity, is key to improving hypoventilation in this population during the first few months after introduction of therapy.
Asunto(s)
Ventilación no Invasiva , Enfermedad Pulmonar Obstructiva Crónica , Insuficiencia Respiratoria , Pared Torácica , Humanos , Ventilación no Invasiva/métodos , Insuficiencia Respiratoria/etiología , Insuficiencia Respiratoria/terapia , Respiración Artificial , Hipercapnia/etiología , Hipercapnia/terapiaRESUMEN
AIM: The aim of this study was to determine the prevalence of likely eating disorders and insulin misuse in a prospective cohort of adults with type 1 diabetes mellitus (T1DM) treated with insulin pump therapy. METHODS: This prospective study was held at the participants' home. The participants completed the SCOFF questionnaire as well as a question related to insulin misuse. Information about lifestyle, medical history, insulin pump and Continuous Glucose Monitoring (CGM) data were collected. RESULTS: The analysis covered 198 participants with a median age of 51 [95% CI 38; 62] years. The prevalence of likely eating disorders was 21.7% (95% CI 16.3; 28.2) in the study population and 20.6% (95% CI 14.3; 28.6) and 24.2% (95% CI 14.6; 37.0) in males and females respectively. The prevalence of insulin misuse was 39.0% (95% CI 30.8; 47.7). There was no significant difference in prevalence between males and females for likely eating disorders and insulin misuse. The analysis of CGM data revealed no factors related to glycaemic control associated with likely eating disorders. CONCLUSION: The results of this study indicate that the prevalence of likely eating disorders is high even in a middle-aged population with a T1DM and satisfactory glucose control.
Asunto(s)
Diabetes Mellitus Tipo 1 , Trastornos de Alimentación y de la Ingestión de Alimentos , Adulto , Masculino , Persona de Mediana Edad , Femenino , Humanos , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/epidemiología , Diabetes Mellitus Tipo 1/complicaciones , Estudios Prospectivos , Automonitorización de la Glucosa Sanguínea/métodos , Prevalencia , Glucemia , Insulina/uso terapéutico , Sistemas de Infusión de Insulina , Trastornos de Alimentación y de la Ingestión de Alimentos/epidemiología , Trastornos de Alimentación y de la Ingestión de Alimentos/complicaciones , Insulina Regular Humana/uso terapéutico , Hipoglucemiantes/uso terapéuticoRESUMEN
BACKGROUND: CPAP is the first-line therapy for OSA. A high or variable residual apnea-hypopnea index (rAHI) reflects treatment failure and potentially is triggered by exacerbation of cardiovascular comorbidities. Previous studies showed that high rAHI and large rAHI variability are associated with underlying comorbidities, OSA characteristics at diagnosis, and CPAP equipment, including mask type and settings. RESEARCH QUESTION: What factors are associated with predefined groups with low to high rAHI variability? STUDY DESIGN AND METHODS: This registry-based study included patients with a diagnosis of OSA who were receiving CPAP treatment with at least 90 days of CPAP remote monitoring. We applied the hidden Markov model to analyze the day-to-day trajectories of rAHI variability using telemonitoring data. An ordinal logistic regression analysis identified factors associated with a risk of having a higher and more variable rAHI with CPAP treatment. RESULTS: The 1,126 included patients were middle-aged (median age, 66 years; interquartile range [IQR], 57-73 years), predominantly male (n = 791 [70.3%]), and obese (median BMI, 30.6 kg/m2 (IQR, 26.8-35.2 kg/m2). Three distinct groups of rAHI trajectories were identified using hidden Markov modeling: low rAHI variability (n = 393 [35%]), moderate rAHI variability group (n = 420 [37%]), and high rAHI variability group (n = 313 [28%]). In multivariate analysis, factors associated with high rAHI variability were age, OSA severity at diagnosis, heart failure, opioids and alcohol consumption, mental and behavioral disorders, transient ischemic attack and stroke, an oronasal mask, and level of leaks when using CPAP. INTERPRETATION: Identifying phenotypic traits and factors associated with high rAHI variability will allow early intervention and the development of personalized follow-up pathways for CPAP treatment.
Asunto(s)
Apnea Obstructiva del Sueño , Persona de Mediana Edad , Humanos , Masculino , Anciano , Femenino , Apnea Obstructiva del Sueño/epidemiología , Apnea Obstructiva del Sueño/terapia , Apnea Obstructiva del Sueño/complicaciones , Insuficiencia del Tratamiento , Polisomnografía , Comorbilidad , Presión de las Vías Aéreas Positiva ContínuaRESUMEN
Over recent years, positive airway pressure (PAP) remote monitoring has transformed the management of OSA and produced a large amount of data. Accumulated PAP data provide valuable and objective information regarding patient treatment adherence and efficiency. However, the majority of studies that have analyzed longitudinal PAP remote monitoring have summarized data trajectories in static and simplistic metrics for PAP adherence and the residual apnea-hypopnea index by the use of mean or median values. The aims of this article are to suggest directions for improving data cleaning and processing and to address major concerns for the following data science applications: (1) conditions for residual apnea-hypopnea index reliability, (2) lack of standardization of indicators provided by different PAP models, (3) missing values, and (4) consideration of treatment interruptions. To allow fair comparison among studies and to avoid biases in computation, PAP data processing and management should be conducted rigorously with these points in mind. PAP remote monitoring data contain a wealth of information that currently is underused in the field of sleep research. Improving the quality and standardizing data handling could facilitate data sharing among specialists worldwide and enable artificial intelligence strategies to be applied in the field of sleep apnea.
Asunto(s)
Apnea Obstructiva del Sueño , Humanos , Apnea Obstructiva del Sueño/terapia , Inteligencia Artificial , Ciencia de los Datos , Reproducibilidad de los Resultados , Resultado del Tratamiento , Polisomnografía , Presión de las Vías Aéreas Positiva Contínua , Cooperación del PacienteRESUMEN
BACKGROUND: Oropharyngeal myofunctional therapy is a multi-component therapy effective to reduce the severity of obstructive sleep apnoea (OSA). However, existing protocols are difficult to replicate in the clinical setting. There is a need to isolate the specific effectiveness of each component of the therapy. OBJECTIVE: To assess the effects of a 6 weeks tongue elevation training programme in patients with OSA. METHODS: We conducted a multicentre randomised controlled trial. Eligible participants were adults diagnosed with moderate OSA who presented low adherence to continuous positive airway pressure therapy (mean use <4 h per night). The intervention group completed a 6 weeks tongue elevation training protocol that consisted in anterior tongue elevation strength and endurance tasks with the Iowa Oral Performance Instrument. The control group completed a 6 weeks sham training protocol that involved expiratory muscle training at very low intensity. Polygraphy data, tongue force and endurance, and OSA symptoms were evaluated pre- and post-intervention. The primary outcome was apneoa-hypopnea index (AHI). RESULTS: Twenty-seven patients (55 ± 11 years) were recruited. According to modified intention-to-treat analysis (n = 25), changes in AHI and c did not significantly differ between groups. Daytime sleepiness (Epworth Sleepiness Scale) and tongue endurance significantly improved in the intervention group compared to the control group (p = .015 and .022, respectively). In the intervention group, 75% of participants had a decrease in daytime sleepiness that exceeded the minimal clinically important difference. CONCLUSION: Six weeks of tongue elevation muscle training had no effect on OSA severity.
Asunto(s)
Trastornos de Somnolencia Excesiva , Terapia Miofuncional , Apnea Obstructiva del Sueño , Lengua , Adulto , Presión de las Vías Aéreas Positiva Contínua , Trastornos de Somnolencia Excesiva/terapia , Músculos Faciales , Humanos , Terapia Miofuncional/métodos , Apnea Obstructiva del Sueño/terapiaRESUMEN
Home mechanical ventilation (HMV) improves quality of life and survival in patients with neuromuscular disorders (NMD). Developing countries may benefit from published evidence regarding the prevalence, cost of equipment, technical issues and organisation of HMV in NMD, facilitating the development of local turn-key HMV programmes. Unfortunately, such evidence is scattered in the existing literature. We searched Medline for publications in English and French from 2005 to 2020. This narrative review analyses 24 international programmes of HMV. The estimated prevalence (min-max) of HMV is ±7.3/100 000 population (1.2-47), all disorders combined. The prevalence of HMV is associated with the gross domestic product per capita in these 24 countries. The prevalence of NMD is about 30/100 000 population, of which ±10% would use HMV. Nocturnal (8/24 hour), discontinuous (8-16/24 hours) and continuous (>16/24 hours) ventilation is likely to concern about 60%, 20% and 20% of NMD patients using HMV. A minimal budget of about 168/patient/year (504/100 000 population), including the cost of equipment solely, should address the cost of HMV equipment in low-income countries. When services and maintenance are included, the budget can drastically increase up to between 3232 and 5760/patient/year. Emerging programmes of HMV in developing countries reveal the positive impact of international cooperation. Today, at least 12 new middle, and low-income countries are developing HMV programmes. This review with updated data on prevalence, technical issues, cost of equipment and services for HMV should trigger objective dialogues between the stakeholders (patient associations, healthcare professionals and politicians); potentially leading to the production of workable strategies for the development of HMV in patients with NMD living in developing countries.
RESUMEN
OBJECTIVE: In obstructive sleep apnea patients on continuous positive airway pressure (CPAP) treatment there is growing evidence for a significant impact of the type of mask on the residual apnea-hypopnea index (rAHI). Here, we propose a method for automatically classifying the impact of mask changes on rAHI. METHODS: From a CPAP telemonitoring database of 3,581 patients, an interrupted time series design was applied to rAHI time series at a patient level to compare the observed rAHI after a mask-change with what would have occurred without the mask-change. rAHI time series before mask changes were modelled using different approaches. Mask changes were classified as: no effect, harmful, beneficial. The best model was chosen based on goodness-of-fit metrics and comparison with blinded classification by an experienced respiratory physician. RESULTS: Bayesian structural time series with synthetic controls was the best approach in terms of agreement with the physician.s classification, with an accuracy of 0.79. Changes from nasal to facial mask were more often harmful than beneficial: 13.4% vs 7.6% (p-value < 0.05), with a clinically relevant increase in average rAHI greater than 8 events/hour in 4.6% of cases. Changes from facial to nasal mask were less often harmful: 6.0% vs 11.4% (p-value < 0.05). CONCLUSION: We propose an end-to-end method to automatically classify the impact of mask changes over fourteen days after a switchover. SIGNIFICANCE: The proposed automated analysis of the impact of changes in health device settings or accessories presents a novel tool to include in remote monitoring platforms for raising alerts after harmful interventions.
Asunto(s)
Apnea Obstructiva del Sueño , Teorema de Bayes , Diseño de Equipo , Humanos , Polisomnografía , Apnea Obstructiva del Sueño/diagnóstico , Apnea Obstructiva del Sueño/terapia , Factores de TiempoRESUMEN
Background: Diet is one of the most important modifiable lifestyle factors in human health and in chronic disease prevention. Thus, accurate dietary assessment is essential for reliably evaluating adherence to healthy habits. Objectives: The aim of this study was to identify urinary metabolites that could serve as robust biomarkers of diet quality, as assessed through the Alternative Healthy Eating Index (AHEI-2010). Design: We set up two-center samples of 160 healthy volunteers, aged between 25 and 50, living as a couple or family, with repeated urine sampling and dietary assessment at baseline, and 6 and 12 months over a year. Urine samples were subjected to large-scale metabolomics analysis for comprehensive quantitative characterization of the food-related metabolome. Then, lasso regularized regression analysis and limma univariate analysis were applied to identify those metabolites associated with the AHEI-2010, and to investigate the reproducibility of these associations over time. Results: Several polyphenol microbial metabolites were found to be positively associated with the AHEI-2010 score; urinary enterolactone glucuronide showed a reproducible association at the three study time points [false discovery rate (FDR): 0.016, 0.014, 0.016]. Furthermore, other associations were found between the AHEI-2010 and various metabolites related to the intake of coffee, red meat and fish, whereas other polyphenol phase II metabolites were associated with higher AHEI-2010 scores at one of the three time points investigated (FDR < 0.05 or ß ≠ 0). Conclusion: We have demonstrated that urinary metabolites, and particularly microbiota-derived metabolites, could serve as reliable indicators of adherence to healthy dietary habits. Clinical Trail Registration: www.ClinicalTrials.gov, Identifier: NCT03169088.
RESUMEN
BACKGROUND: Whether the COVID-19 pandemic impacts Positive Airway Pressure (PAP) adherence over the long-term is unknown and only preliminary short-term data have been reported. METHODS: With the aim of describing the impact of the first and second waves of COVID-19 on PAP adherence during 2020 in France, we designed a cross-sectional study of Sleep-Apnea (SA)-patients under PAP telemonitoring. To examine PAP adherence in adult SA patients, we assessed de-identified data from a non-profit healthcare provider database during the period January 1, 2019 to December 31, 2020. Included patients met the following criteria: (i) PAP-treated for at least 4 months before January 1, 2019 and with continuous PAP during both 2019 and 2020; (ii) ≥ 360 daily PAP telemonitored data per year. For PAP adherence, data were collected using the PAP-software. RESULTS: 8477/10482 patients were finally included in the analysis [72.4% male, median age 70 years (IQ25-75: 61-77], 25.6% < 62 years old, initial Apnea-Hypopnea Index (AHI) of 41 (31-59)/h. Median PAP adherence was 7.21 (6.12-8.10) h/day in 2020 versus 7.12 (6.05-8.02) h/day in 2019, p < 0.001. The median difference in PAP adherence between the first 2020 lockdown and the corresponding 2019 weeks was 9.75 (CI95% 8.75-10.75) min/day, p < 0.001. The median difference in PAP adherence between the second 2020 lockdown and the corresponding 2019 weeks was 5.00 (CI95% 4.00-6.00) min/day, p < 0.001. If we consider the minimal clinically important difference of 30 min for PAP adherence, 30.4% and 26% of the patients increased their PAP adherence by at least 30 min during the first and second lockdowns respectively; 17.6% and 19.3% of the patients lowered their PAP adherence by at least 30 min in the first and second lockdowns, respectively. CONCLUSION: During the first and second lockdowns, the COVID-19 pandemic had a clinically irrelevant effect on PAP adherence for the study population. Future studies are needed to describe COVID-19 pandemic impact on PAP adherence not only for long-term PAP-treated SA patients but also for incident cases. Trial registration The COVADENE study was registered on March 1st, 2021 on ClinicalTrials.gov (Identifier: NCT04775966).
Asunto(s)
COVID-19/epidemiología , Presión de las Vías Aéreas Positiva Contínua/métodos , Pandemias , Síndromes de la Apnea del Sueño/terapia , Cumplimiento y Adherencia al Tratamiento , Anciano , Comorbilidad , Estudios Transversales , Femenino , Francia/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Polisomnografía , Estudios Retrospectivos , Síndromes de la Apnea del Sueño/epidemiología , Resultado del TratamientoRESUMEN
BACKGROUND: Continuous positive airway pressure (CPAP), the reference treatment for obstructive sleep apnoea (OSA), is used by millions of individuals worldwide with remote telemonitoring providing daily information on CPAP usage and efficacy, a currently underused resource. Here, we aimed to implement data science methods to provide tools for personalizing follow-up and preventing treatment failure. METHODS: We analysed telemonitoring data from adults prescribed CPAP treatment. Our primary objective was to use Hidden Markov models (HMMs) to identify the underlying state of treatment efficacy and enable early detection of deterioration. Secondary goals were to identify clusters of rAHI trajectories which need distinct therapeutic strategies. RESULTS: From telemonitoring records of 2860 CPAP-treated patients (age: 66.31 ± 12.92 years, 69.9% male), HMM estimated three states differing in variability within a given state and probability of shifting from one state to another. The daily inferred state informs on the need for a personalized action, while the sequence of states is a predictive indicator of treatment failure. Six clusters of rAHI trajectories were identified ranging from well-controlled patients (cluster 0: 669 (23%); mean rAHI 0.58 ± 0.59 events/h) to the most unstable (cluster 5: 470 (16%); mean rAHI 9.62 ± 5.62 events/h). CPAP adherence was 30 min higher in cluster 0 compared to clusters 4 and 5 (P value < 0.01). CONCLUSION: This new approach based on HMM might constitute the backbone for deployment of patient-centred CPAP management improving the personalized interpretation of telemonitoring data, identifying individuals for targeted therapy and preventing treatment failure or abandonment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13167-021-00264-z.