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NCT06311045
This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA.
NCT07482033
This study is a randomized, controlled experimental trial with a pretest-posttest design, conducted to evaluate the effects of Pecha Kucha-based education on self-efficacy, symptom level, and activities of daily living in individuals diagnosed with chronic obstructive pulmonary disease (COPD) receiving noninvasive mechanical ventilation support. The study will include two groups, and intergroup differences will be evaluated: 1. Control group 2. Intervention group Study Hypotheses H1: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) increases patients' self-efficacy levels. H2: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) reduces patients' symptom levels. H3: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) improves patients' activities of daily living.
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.
NCT07444372
Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence. This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA. Participants will: * Be randomly assigned to either the CPAP group or the usual care group. * If in the CPAP group, use a CPAP device for 12 months. * Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months post-operation. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after their procedure.
NCT06712563
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.
NCT07190209
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.
NCT05746039
The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question\[s\] it aims to answer are: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
NCT07539870
The goal of this clinical trial is to evaluate the isolated and combined effects of orofacial myofunctional therapy (OMT) and continuous positive airway pressure (CPAP) in adults with mild-to-moderate obstructive sleep apnea. The main questions it aims to answer are whether OMT alone, CPAP alone, or combined OMT plus CPAP improves obstructive sleep apnea severity at Week 12, as measured by the apnea-hypopnea index (AHI), and whether these interventions improve mandibular excursion. Researchers will compare 4 groups-sham plus standard of care, OMT plus standard of care, CPAP plus standard of care, and combined OMT plus CPAP plus standard of care-to assess differences in respiratory and anatomical-functional outcomes. Participants will be randomized to 1 of the 4 study arms. During the 12-week supervised intervention phase, participants will receive their assigned intervention together with standardized sleep-hygiene and lifestyle counseling. Assessments include sleep recording, mandibular excursion measurements, questionnaires on sleepiness and sleep quality, dento-occlusal and anthropometric measurements, and treatment adherence monitoring. After Week 12, participants will enter an observational follow-up phase through Week 52 to evaluate durability of treatment effects, treatment persistence, symptom recurrence, and clinically indicated treatment modifications.
NCT07307781
This Study is multicenter, non-interventional, ambispective registry to evaluate the demographic and clinical characteristics, therapeutic approaches and outcomes in COPD outpatients with frequent exacerbations in Moscow
NCT07376343
The goal of this observational study is to compare predictive equations for continuous positive airway pressure (CPAP) with in-laboratory manual titration in patients with obstructive sleep apnea (OSA). The main question the study aims to answer is: Which CPAP predictive equation best predicts the optimal CPAP pressure in OSA patients in Thailand? Participants will undergo an in-laboratory sleep study.
NCT04700098
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
NCT07073950
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
NCT04701983
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD * Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD * Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD * Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
NCT07518472
Chronic Obstructive Pulmonary Disease is progressive and irreversible respiratory condition characterized by persistent airflow limitation leading to dyspnea and reduced functional capacity. Pulmonary rehabilitation along with different technqiues of breathing exercises reduces dyspnea and enhance functional capacity by improving ventilatory efficiency, respiratory muscle control and overall exercise tolerance in patients with COPD.
NCT07509606
Chronic obstructive pulmonary disease (COPD) is an irreversible disorder characterized by persistent airflow limitation and increased lung compliance. It leads to dyspnea, skeletal muscle dysfunction, impaired functional capacity, and reduced quality of life. Physical inactivity is considered a major contributor to symptom deterioration, the development of a vicious cycle, and ultimately increased mortality. According to the American College of Sports Medicine (ACSM), the American Thoracic Society (ATS), and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), pulmonary rehabilitation should include aerobic and resistance exercise for at least 20 minutes per session, performed three to five times per week for a minimum of 12 weeks. Exercise intensity should be progressively increased to exceed 60% of peak oxygen uptake (VO₂peak), and patients are encouraged to maintain long-term exercise habits. However, there is still no consensus regarding the optimal initial intensity, progression strategy, and exercise duration. Previous studies have demonstrated that whole-body vibration (WBV) can improve lower extremity muscle strength, functional capacity, and quality of life in patients with COPD. However, its effects on lung function and the optimal training dose remain unclear. In addition, COPD also affects respiratory muscles, upper extremity strength and flexibility, as well as cardiac autonomic function. Therefore, the aim of this study is to investigate the effects of different WBV frequencies on lung function, respiratory muscle function, upper extremity strength and flexibility, and cardiac autonomic function, in order to determine the optimal training dose.
NCT07343375
Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but there is a lack in understanding the underlying mechanism of exercise-induced improvement in COPD and it is widely thought not to have any effect on the lung as such. In the present study, the investigators aim to investigate the impact of an extensive high-intensity interval training (HIIT)-based exercise scheme on the regenerative capacity of the lung in patients with COPD on waiting list for lung volume reduction surgery. Design: Prospective randomized controlled clinical trial. Intervention: 24 persons with COPD referred for lung volume reduction surgery will randomly be allocated (1:1) to prehabilitation with high intensity interval training (HIIT) or non-exercise control. Outcomes: The primary outcome is differences in change in differential protein composition in distal lung tissue between HIIT and control groups post-intervention using spatial multimodal proteomics. Furthermore, lung tissue mass, protein composition (mass spectrometry and spatial omics e.g. MACSima), pulmonary blood volume, blood protein profile (biomarkers), diffusion capacity at rest and during exercise, oxygen consumption tests, body composition scan, distal airspace radii and physical functional tests will be measured before and after the intervention. Perspective: This study may fundamentally change the view on the regenerative potential of the lungs in COPD.
NCT07451977
The aim of this multicenter crossover trial is to describe the effect of adding a therapeutic dose of exertional oxygen therapy, in terms of exercise performance, gas exchange, heart rate, symptoms perception and subjective easiness of performance, in a cohort of subjects hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and/or exertional hypoxemia due to chronic obstructive pulmonary disease or interstitial lung disease. Researchers will compare the walking performance during 6-minute walk test performed with the liters of oxygen administered as prescribed at rest (for patients with chronic respiratory failure) or in room air (for patients with exertional hypoxemia only), to the performance during a 6-minute walk test performed with the double the flow rate prescribed at rest, or with 2 L/min for patients with exertional hypoxemia only. The two tests will be performed in random order, at least 3 hours apart and no later than 24 hours apart from each other. The main outcome will be the difference between the distance walked in the two 6-minute walk test in the two conditions. Furthermore, will be also collected and compared: the oxygen saturation and heart rate every minute, the initial and final dyspnea and fatigue, as assessed by Borg scale, and the easiness of performance through a dedicated questionnaire. The estimated sample size will be 114 patients. This study will provide some basis for a more accurate prescription of exercise-related oxygen therapy, offering insights into the phenotype of patients who may derive the greatest benefit from this intervention. It will also stimulate discussion regarding the optimal timing and dosing of oxygen administration during exertion in patients with respiratory failure.
NCT07497230
This randomized pilot trial evaluated the feasibility and preliminary effects of using asymmetric high-flow nasal cannula (A-HFNC) during exercise-based pulmonary rehabilitation (PR) in patients with chronic obstructive pulmonary disease (COPD). Thirty patients were randomly assigned to conventional PR or PR supplemented with A-HFNC during aerobic training, completing 12 supervised sessions. The study assessed whether A-HFNC could be safely and acceptably incorporated into PR, and whether it enabled higher training intensity and improved exercise performance. Results showed that the intervention was feasible and safe, with 83% adherence in both groups and no adverse events. Patients in the A-HFNC group trained at significantly higher treadmill inclination and showed a clinically meaningful trend toward greater improvement in maximal exercise tolerance. These findings support the design of a larger definitive trial.
NCT07456176
Chronic Obstructive Pulmonary Disease (COPD) is a progressive inflammatory lung disease characterized by persistent airflow limitation and enhanced oxidative stress. Acute exacerbations of COPD (AECOPD) significantly increase morbidity, accelerate lung function decline, and worsen clinical outcomes. Oxidative stress plays a central role in AECOPD pathophysiology by amplifying inflammation through mediators such as IL-8 and TNF-α, leading to airway injury and impaired gas exchange. Alpha Lipoic Acid (ALA) is a potent antioxidant and anti-inflammatory agent that scavenges reactive oxygen species, regenerates endogenous antioxidants, and modulates redox-sensitive inflammatory pathways. Although preclinical evidence supports its protective role in respiratory diseases, no randomized clinical trial has evaluated ALA in AECOPD or compared different dosing strategies. Aim This study aims to evaluate and compare the effects of low-dose (600 mg/day) versus high-dose (1200 mg/day) ALA on oxidative stress markers, inflammatory biomarkers, clinical recovery, pulmonary oxygenation, gas exchange, and safety in patients with AECOPD. Methods This is a prospective, double-blind, randomized controlled trial conducted in the ICU at El Matareya Teaching Hospital. Adult patients (40-70 years) with confirmed COPD and frequent exacerbations were randomized (1:1:1) into three groups: Group A: Standard therapy + placebo Group B: Standard therapy + 600 mg/day oral ALA Group C: Standard therapy + 1200 mg/day oral ALA All patients received guideline-based AECOPD management according to GOLD recommendations, including bronchodilators, systemic corticosteroids, antibiotics (when indicated), oxygen therapy, and ventilatory support as needed. Assessments Baseline and Day 10 evaluations included: Primary Outcomes: Oxidative stress marker: Malondialdehyde (MDA) Inflammatory markers: Interleukin-8 (IL-8) and C-reactive protein (CRP) Secondary Outcomes: Time to clinical stability ICU and hospital length of stay Need for non-invasive or invasive ventilation Early relapse (14 days) and 30-day readmission Gas Exchange: ABGs (pH, PaO₂, PaCO₂, P/F ratio) Patient-Reported Outcomes: COPD Assessment Test (CAT) and mMRC dyspnea scale Safety: Monitoring for adverse effects including gastrointestinal symptoms, hypoglycemia, dizziness, and hypersensitivity reactions.
NCT06722755
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.