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Showing 1-20 of 1,726 trials
NCT05052216
Background: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects. Researchers want to see how a monitoring device called near-infrared spectroscopy (NIRS) compares with the traditional techniques used in children s sleep studies. Objective: To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor. Eligibility: Children aged 3-12 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group). Design: Participants will be screened with a review of their medical records. If they have taken part in other NIH studies, that data will be reviewed as well. Participants in the NORM group will have 1 overnight study visit. Those in the OSA group will have 2 overnight study visits. Participants will do an overnight sleep study. They will have a physical exam and medical history. They will have a sleep study electroencephalography (EEG). For this, electrodes will be placed on their head. They will wear a gauze cap to keep the electrodes in place. Two NIRS probes made of a soft silicon will be placed on their forehead and arm. They will follow their normal bedtime routine. Their parent will stay overnight. The OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea. They will repeat the sleep study.
NCT06511193
The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol \[BGF\] in a real-world setting.
NCT07665931
Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. This study tests whether a single session with a medical device called Simeox® can reduce the amount of air trapped in the lungs. Simeox® works by applying gentle intermittent negative pressure during exhalation to help air move out of the lungs more easily. Patients with severe or very severe COPD and documented hyperinflation will undergo lung function measurements before and immediately after a 20-minute Simeox® session. The main measurement is the change in residual volume (RV), which is the amount of air left in the lungs after a full exhalation. We will also measure changes in other lung volumes, breathlessness, and any side effects. This is a single-arm pilot study enrolling 23 patients at one center in Italy (ASST Lodi). The study is non-profit and has been approved by the Ethics Committee Comitato Etico Territoriale Lombardia 1 (CET Lombardia 1).
NCT05607719
The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.
NCT07646587
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)
NCT05743582
Chronic Obstructive Pulmonary Disease (COPD) causes obstruction to airflow when breathing out. It is a leading cause of chronic lung disease, hospitalization and death. Smoking is the major cause of COPD but why some smokers develop COPD while others do not is poorly understood. A central feature of COPD is accumulation of inflammatory blood cells, macrophages and neutrophils, in the airway, leading to lung injury and airway damage. The small airways of many patients with COPD contain bacteria, which are absent in healthy smokers or non-smokers. These bacteria stimulate recruitment of neutrophils, macrophages and other inflammatory cells, further accelerating airway injury. The investigators and others have shown resident macrophages in the lung and inflammatory cells (neutrophils and macrophages) recruited from the blood, which normally clear bacteria, have reduced anti-bacterial capacity in COPD and that their altered function impairs the resolution of inflammation. The investigators now wish to test why these cells fail to clear bacteria focusing in particular on how they use molecules as food to generate energy, a process termed metabolism, since this is an important determinant of immune cell function. Comparison will be made between lung resident cells (obtained by performing bronchoscopy and washing a segment of lung to flush out immune cells) and those from the blood to determine if the alterations are specific to the lung. The investigators will identify alterations in responses to bacteria in relation to changes in metabolism . A major focus will be on how structures in the cell that normally are key for energy production (i.e. mitochondria) become dysfunctional and how this impacts responses to bacteria. The investigators will relate findings to the clinical features of COPD and to healthy non-smokers and smokers to separate smoking-related changes from COPD. The aim is to develop new approaches with which to treat and manage COPD.
NCT07190222
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
NCT03718780
The study aim is to monitor, during exercise tests carried out in various conditions, the alveolar dead space, by means of continuous transcutaneous measurement of Pt CO2, which would be used as a surrogate for arterial PaCO2. Validity of this measurement needs to be assessed against arterial sampling (either arterial, or arterialized capillary), especially with regards to the lag time required by the CO2 diffusion from the arterial compartment (PaCO2) to the cutaneous one (PtCO2), in particular when rapid changes of CO2 might be induced by exercise. The evaluation will be done in 2 different settings: * intensive care patients, equipped, for their routine clinical care, with an arterial line; this allows for a precise timed comparison between PaCO2 and PtCO2 readouts; * routine exercise test, where blood gas evaluation is done essentially by means of arterialized earlobe capillary sampling. Following assessment of validity of the measurement (and the lag time PaCO2-PtCO2 which might be necessary to introduce as a correction), evolution of dead space during excise test will be tested in different conditions: Healthy subjects, patients with Chronic Obstructive Pulmonary Disease (COPD), chronic heart failure (CHF), hyperventilation, Pulmonary artery hypertension (PAH), or interstitial lung disease (ILD)
NCT01692444
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown. The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.
NCT07047092
Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide. Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated. Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
NCT06283017
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.
NCT07580170
The aim is to investigate whether the tissue-preserving tonsil surgery technique is as effective as complete tonsil removal in the treatment of obstructive sleep apnea. The primary outcome measure is the change in the apnea-hypopnea index (AHI) before surgery and at 4-6, 24, and 60 months after surgery.
NCT04939454
Chronic obstructive pulmonary disease (COPD) is presently the third leading cause of death worldwide and is characterized by irreversible airflow limitation diagnosed by spirometry. COPD is currently considered as a systemic disease with predominantly respiratory involvement, associated with numerous comorbidities. Among these, muscle wasting, present in about one third of patients, is associated with a higher mortality (up to 10-fold, irrespective of the severity of the obstruction). Muscle wasting is classically characterized by a decrease in muscle strength and volume (sarcopenia), which can be defined by a decrease in the muscle mass measured by dual X-ray absorptiometry: Appendicular Skeletal Muscle Mass or ASM / height \< 7.0 kg/m2 in men and 5.5 kg/m2 in women. However, sarcopenia is largely underestimated in current clinical practice. Moreover, there is no specific treatment: only exercise training as part of respiratory rehabilitation has shown some efficiency. The underlying pathophysiological mechanisms are indeed poorly characterized. Fibrocytes, cells derived from blood monocytes and able to migrate to different organs in order to play pro-fibrotic or pro-inflammatory roles, play a key role in bronchial obstruction. They are recruited in the blood of COPD patients during an acute exacerbation according to a CXCL12/CXCR4 chemotactic axis. Their role in COPD sarcopenia is currently unknown, but recent data show that they are involved in a mouse model of muscular dystrophy. The hypothesis is that fibrocytes are involved in COPD sarcopenia.
NCT07160868
The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma. Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group). The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization. This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.
NCT05008081
The CATALINA study is a prospective cohort study embedded within CICERO (Collaboration In COPD ExaceRbatiOns, a European Respiratory Society supported Clinical Research Collaboration), designed to collect standardised, longitudinal clinical data and biological samples in 20 centres across Europe and beyond.
NCT06208306
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 weeks * A follow-up period of 20 weeks will be conducted * The number of on-site visits will be 7 and the number of phone contacts will be 5
NCT07587658
This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days). The study is looking at another research question: • What side effects may happen from taking the study drug
NCT07579052
This prospective observational cohort study aims to prospectively evaluate and validate the Clinical Load, Exchange, Ability of Respiration, and Reserve (CLEAR) model for predicting sustained ventilatory liberation in patients with severe chronic obstructive pulmonary disease (COPD) receiving invasive mechanical ventilation (MV) or non-invasive ventilation (NIV). Two parallel cohorts will be studied: CLEAR-MV for patients undergoing spontaneous breathing trials (SBT) and CLEAR-NIV for patients undergoing NIV withdrawal trials. The model integrates diaphragm ultrasound evaluating diaphragm thickening fraction (DTF), ventilatory load indices including the rapid shallow breathing index (RSBI) or Clinical Load Index (CLI), gas exchange parameters including Potential of Hydrogen (pH), partial pressure of carbon dioxide (PaCO₂), and its change over time (ΔPaCO₂) combined as the Gas Exchange Index (GEI), and peripheral muscle reserve assessing rectus femoris (RF) and vastus intermedius (VI) thickness. The primary outcome is successful liberation from ventilatory support within 72 hours. Secondary outcomes include ventilatory failure within 7 days, ventilator- or NIV-free days at 28 days, and time-fixed 90-day clinical outcomes including all-cause mortality, sustained ventilatory independence, and rehospitalization for respiratory failure. Model performance will be evaluated using discrimination (area under the receiver operating characteristic curve), calibration (calibration intercept and slope), and clinical utility (decision curve analysis and net benefit) and compared with prespecified established ventilatory indices, including the Rapid Shallow Breathing Index (RSBI) and Integrative Weaning Index (IWI) in the invasive mechanical ventilation cohort, and the Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score and the ratio of peripheral oxygen saturation to fraction of inspired oxygen divided by respiratory rate (ROX) index in the non-invasive ventilation cohort.
NCT06847061
The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.
NCT05061368
Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion. The mechanisms responsible for shortness of breath on exertion are well understood in moderate and severe COPD, but, are poorly understood in mild COPD where symptoms appear disproportionate to the degree of airway obstruction. Mild COPD patients show an exaggerated breathing response to exercise, determined by the breathing response to carbon dioxide production (V̇E/V̇CO2). Recent work suggests that the increased V̇E/V̇CO2 during exercise in mild COPD is secondary to increased deadspace (i.e. lung regions with ventilation but no perfusion) and/or ventilation/perfusion (V̇A/Q) inequality (poor matching of ventilation to perfusion). Researchers have proposed that the increased deadspace or V̇A/Q inequality is secondary to pulmonary vascular dysfunction and hypoperfusion of the pulmonary capillaries. Recently, we have shown that inhaled nitric oxide, a potent dilator of pulmonary vasculature, reduces shortness of breath and V̇E/V̇CO2, and improves exercise capacity in mild COPD. This preliminary finding suggests that pulmonary vascular dysfunction is an important contributor to exercise intolerance in mild COPD. Here, we aim to test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.