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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT05267808 Recruiting - Clinical trials for Obstructive Sleep Apnea

Pathophysiological Endotyping Using Baseline Polysomnography Data

Start date: February 1, 2022
Phase:
Study type: Observational

The study is designed to develop models to predict site of collapse information using routine polysomnography. In an observational study, the investigators will study 1000 patients with obstructive sleep apnea (OSA) who have had a recent polysomnographic study and will undergo drug-induced sleep endoscopy (DISE) as part of their standard clinical care. Flow shape information from the polysomnographic study will be associated with the DISE results, and a set of prediction models will be developed and validated to detect the site, pattern and degree of upper airway collapse as seen during DISE.

NCT ID: NCT05262439 Recruiting - Clinical trials for Obstructive Sleep Apnea

Post Market Clinical Follow up of ResMed Mask Systems

Start date: May 26, 2022
Phase: N/A
Study type: Interventional

Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

NCT ID: NCT05246449 Recruiting - Clinical trials for Obstructive Sleep Apnoea Syndrome (OSAS)

Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP

VitalCare
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

According to a stratification procedure, the objective of a personalised care plan (VitalCare) is to identify points for improvement since the early stage of the patient's pathway of CPAP/APAP treatment and to adjust patient follow-up .

NCT ID: NCT05245240 Recruiting - Obesity Clinical Trials

Novel Inhibitors of Lipolysis in the Treatment of Lipid a Glucose Metabolism in Obstructive Sleep Apnea Syndrome

NORRIS
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSA) represents highly prevalent (typically overlooked, undiagnosed and untreated) disorder significantly increasing cardiovascular, cancer and overall mortality as well as increasing the risk of Type 2 diabetes and liver steatohepatitis. Unfortunately, adherence to state-of-the-art therapy with continuous positive airway pressure devices (CPAP) is poorly tolerated by patients, rendering a significant proportion (~60-70 %) of them at undiminished cardiovascular and metabolic risk warranting development of innovative, pharmacological, treatment options. The overarching theme of this project is that metabolic impairments associated with OSA (e.g. Type 2 diabetes mellitus and non-alcoholic steatohepatitis) are causally mediated by elevated levels of circulating free fatty acids (FFA) originating from hypoxia-induced adipose tissue lipolysis. Increased plasma FFA subsequently induce insulin resistance, β-cell dysfunction, increase hepatic glucose output and stimulate lipid storage in liver. The investigators recently proved that hypoxia represents a powerful stimulus for adipocyte lipolysis and that experimental pharmacological inhibition of lipolysis prevented development of Type 2 diabetes in a mouse model of OSA. The goal of the project is to understand adipose tissue lipolysis derangements in OSA subjects and to evaluate the feasibility of lifestyle intervention as a mean to reduce spontaneous lipolysis.

NCT ID: NCT05237505 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

CRESCENDO-SLP
Start date: February 13, 2024
Phase: Phase 2
Study type: Interventional

Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear. The combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues. The purpose of this study is to examine vascular mechanisms in individuals with COPD/OSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.

NCT ID: NCT05224180 Recruiting - Lung Cancer Clinical Trials

OSA in Never Smokers With Lung Cancer

Start date: November 3, 2021
Phase:
Study type: Observational

Previous studies have yielded inconsistent findings regarding the association between obstructive sleep apnea and the prevalence and mortality of lung cancer. Smoking history, a common risk factor for lung cancer, chronic obstructive pulmonary disease, and obstructive sleep apnea, may act as a confounding variable, limiting interpretation of the results. The aim of this study is to evaluate the prevalence of obstructive sleep apnea in never smokers with lung cancer and to determine the effect of obstructive sleep apnea on the prognosis of lung cancer. Enrolled patients will undergo respiratory polygraphy before beginning treatment for lung cancer. This prospective cohort includes both cross sectional and longitudinal analyses.

NCT ID: NCT05209035 Recruiting - Clinical trials for Obstructive Sleep Apnea

Evaluation of Trazodone in OSA-MCI

Start date: May 10, 2022
Phase: Phase 4
Study type: Interventional

Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD. A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.

NCT ID: NCT05197855 Recruiting - Clinical trials for Obstructive Sleep Apnea

Sleep Quality Evolution: Dreem Under CPAP

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic recording. This is related to the cost of performing these studies with repeated recordings in the laboratory and to the acceptability by patients to perform multiple nights of recordings. Investigators currently have powerful and reliable methods allowing us to carry out nights at home in the patient's ecosystem, in real-life conditions. The characterization of sleep parameters by these methods is equivalent to a polysomnographic recording. These technological innovations will allow us to characterize sleep before the initiation of CPAP treatment during several nights performed at home. Investigators will then be able to characterize the kinetics and stability of the improvement of sleep parameters in patients with obstructive sleep apnea syndrome in whom continuous positive airway pressure is initiated. These data will be original and will serve as exploratory data to judge whether the objective improvement of sleep parameters in the first weeks of treatment is associated with improvement in sleepiness, quality of life, and compliance with treatment.

NCT ID: NCT05156112 Recruiting - Clinical trials for Obstructive Sleep Apnea

OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.

NCT ID: NCT05147649 Recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

IRM SAOS
Start date: March 2, 2023
Phase: N/A
Study type: Interventional

The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.