Active clinical trials for "Obesity Hypoventilation Syndrome"

This is a randomized, double blind, placebo-controlled, cross-over, phase II, single center efficacy study of AD981 in patients with obesity hypoventilation syndrome documented by polysomnography (PSG) and transcutaneous, overnight measurement of CO2 (PtcCO2).

Obesity Hypoventilation Syndrome is defined as a combination of obesity (BMI ≥ 30 kg/m2) and daytime hypercapnia in arterial blood gas analysis (PaCO2 > 45 mmHg) without other pathologies that cause hypoventilation. Symptoms seen in individuals diagnosed with OHS are stated as a feeling of suffocation due to apnea, loud snoring, morning headache and excessive daytime sleepiness. Respiratory mechanics, respiratory muscle performance, pulmonary gas exchange, lung functions and exercise capacity parameters are adversely affected in patients. Early treatment is important so that these negative changes do not lead to worse outcomes. Weight control, bariatric surgery, pharmacological treatment and non-invasive mechanical ventilation (NIMV) are included in the treatment program of OHS patients. The effects of exercise on the treatment program of OHS patients are unknown. Considering all the studies in the literature, the primary purpose of this study is to evaluate aerobic and strength training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters. In addition, the researchers believe that this study will form the basis for further scientific studies on OHS and exercise and will make an important contribution to the literature.

Chronic hypercapnic respiratory failure (CHRF) in the context of Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) is associated with increased mortality. The availability and effectiveness of domiciliary Non-invasive ventilation (NIV) treatment (when indicated) is key as this treatment can improve quality of life and reduce health-care costs from associated burden of disease. The emerging obesity epidemic means that there is now increased home mechanical ventilation set-ups in patients with obesity related respiratory failure (ORRF), yet there are no alternative treatments for patients struggling with domiciliary NIV. Domiciliary NHF has been shown to improve health related quality of life in stable CHRF in patients with COPD and improve cost effectiveness yet there are no current studies looking at the use of domiciliary NHF and its outcomes in ORRF. The study aims to deliver a pre and post intervention study evaluating patient reported and clinical outcomes in patients using NHF over twelve weeks, who have either COPD or OHS and have been unable to use domiciliary NIV. The study wishes to address key outcomes such as quality of life, clinical effectiveness, compliance and acceptability with the use of domiciliary NHF in both of these patient populations.

Patients are invited to participate in a trial to test a new way to optimise long-term use of non-invasive ventilation using remote monitoring. Breathing difficulties during sleep are frequently treated using home mechanical ventilation, also called non-invasive ventilation (NIV). Breathing difficulties during sleep affect many patients with conditions such as chronic pulmonary obstructive disease (COPD), neuromuscular conditions and obesity hypoventilation syndrome. Left untreated they can cause breathlessness, headaches, sleepiness and lead to hospitalisations and other severe adverse health outcomes. The best available treatment for chronic types of sleep-disordered breathing is NIV. However, not every patient eligible tolerates this treatment because it requires patients to sleep with a nasal or full-face mask that is connected with a tube to a machine. Although NIV is recommended by the National Institute for Health and Clinical Excellence (NICE), many patients who should be on NIV use the treatment insufficiently within months. Using remote monitoring to identify problems with treatment adherence early on may help to identify clinical problems, troubleshoot user- or device-dependent problems, avoid delays in treatment and safe healthcare resources in the long-term. The investigators invite patients who use NIV to participate in this trial when they have difficulties with the treatment (NIV). This study will evaluate compliance and efficacy of a remote monitoring device (T4P device, SRETT, Paris/France) that will be connected to the standard NIV machine to remotely monitor usage. Patients will be randomly assigned to the remote monitoring using NIV for three months at home, or to usual care which is NIV without this monitoring. The primary outcome measure of this study is the improvement in adherence and compliance, as indicated by the average usage of NIV, as well as symptom scores to assess treatment effects.

The goal of this clinical trial is to clinically validate a system for the monitoring of patients' respiratory function and automated oxygen treatment proposal using non-invasive ventilation devices in the treatment of intensive care patients with acute or chronic lung diseases exacerbations. Participants clinical parameters will be monitored and samples will be sent to a clinical laboratory for analysis (arterial blood pressure, heart rate, and respiratory rate will be continuously recorded, and FeO2 and CO2 will be measured with the help of an additional sensor).

Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.

Assessment of benefits of HVNI in management of obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure. Compare the value, safety and effectiveness of HVNI and NIV in patients with obesity hypoventilation syndrome complicated with acute hypercapnic respiratory failure.

Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss. Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation. Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.

Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

Continuous positive airway pressure and non-invasive ventilation are common treatment modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar hypoventilation from a variety of causes. Use of positive airway pressure (PAP) requires use of an interface, commonly referred to as a "mask." There are a range of mask options available, differing in configuration and sizing, including masks that fit into the nostrils (nasal pillows, NP), cover the nose (nasal masks, NM), cover both the nose and the mouth (oronasal masks, ONM), and rarely those that fit into the mouth (oral masks, OM) or over the entire face. The variety of masks, sizes, and materials result from the wide variety of facial configurations and patient preferences along with requirements to provide a good seal for varying pressure requirements. Failure to find a good match for a given patient may result in significant side effects, such as eye irritation owing to leak into the eyes, skin pressure sores, noise generation, and inadequate therapy when air leaks are extreme. Pressure sores, mask dislodgement, claustrophobic complaints, air leaks, and sore eyes occur in 20-50% of patients with OSA receiving PAP, and these effects negatively correlate with PAP compliance. Furthermore, several trials point to differences in compliance related to which types of masks are utilized. In a randomized cross-over trial, compliance was 1 hour more per night in patients using NM compared to those using ONM.1 In another, NPs were associated with fewer adverse effects and better subjective sleep quality than NMs.2 Therefore, failure to find an acceptable mask results in lower or non-compliance, and therefore treatment failure. Currently, finding a right mask is performed either using crude templates, or via an iterative process, variably guided by experts in mask fitting. There are no standard certifications or algorithms to guide mask fitting. Given the above, it would be very desirable to find a reliable method to reduce the errors in mask fitting so that the costs, inconvenience, and suffering are all reduced.