View clinical trials related to Apnea.
Filter by: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.
multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (STM) compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.
Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. The number of nocturnal respiratory anomalies per hour of sleep characterizes the severity of the disease with a gradual gradation of severity from mild (from 5 to 15 anomalies per hour) to moderate (15 to 30 anomalies per hour) and severe (over 30 anomalies per hour). The rationale for this severity classification is the increase in morbidity and mortality proportional to the severity of OSA as defined. OSA is accompanied by a fragmentation of sleep often responsible for excessive daytime sleepiness, causing an increase in occupational accidents with work stoppage and traffic accidents. The second consequence of repeated nocturnal obstructions is chronic intermittent nocturnal hypoxia which has deleterious cardiovascular effects, constituting an independent cardiovascular risk factor. Shear waves are elastic waves of low frequency (less than 1000 oscillation per second - 1000Hz). It propagates only in solids and soft solids such as the human body. The propagation of a shear wave generates a reversible micrometric displacement of the particles that make up this medium. The energy of these waves is related to the amplitude of movement of the particles. Elastography is an imaging modality for measuring the elasticity of biological tissues by shear waves. The shear wave is a mechanical wave sensitive to the change in the elasticity of its propagation medium. This sensitivity is manifested by the variation of its propagation speed. Hardness results in acceleration of the wave and softness in its slowing down. The therapeutic use of shear waves has never been used for the treatment of sleep apnea but its use could be an additional therapeutic arsenal of Continuous Positive Pressure. The technology developed by BREAS MEDICAL AB is based on the use of shear waves for the treatment of sleep apnea. The treatment is delivered using a cervical collar equipped with six sources (vibrating pistons) generating shear waves. The treatment generates shear waves at frequencies that vary from 20 to 250 Hz continuously, and at amplitudes less than 50 microns of the same order of magnitude of vibration as snoring. In view of the innovative nature of the treatment, the medico-technical team of BREAS MEDICAL AB carried out an analysis of the risks related to the device and to the propagation of waves, including the norms and standards imposed by the competent bodies. The investigators would like, in a first-dose study in humans, to assess safety in patients with sleep apnea syndrome.
In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors and sounds recorded with a smartphone is studied by making an overnight recording to patients with high probability of sleep apnoeas. The data acquired with the aforementioned devices is: ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase it will be studied which combinations of these signals would enable detecting sleep apnoeas with high enough sensitivity and specificity when compared to a night polygraphy reference (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen saturation, pulse and leg EMG).
Apneic oxygenation describes the process of continuous oxygenation of the blood without breathing efforts. This anesthesia technique has been described in the literature for more than 100 years and is sometimes used under general anesthesia, e.g. during surgery of the vocal chords. Although this technique usually provides marked prolongation of the apneic period because of excellent oxygenation, it is limited by the absence of ventilation and the corresponding accumulation of carbon dioxide in the blood. This will lead to worsening respiratory acidosis and associated complications, such as cardiac arrythmias. In 2015 it was reported that apneic oxygenation with high-flow nasal oxygen delivery systems (HFNO), a device that provides heated humidified oxygen at high flow rates (usually 30-70 L/min), resulted in less carbon dioxide accumulation compared with historical controls. This specific technique of apneic oxygenation was termed transnasal humidified rapid-insufflation ventilation exchange (THRIVE). To date, the impact on different flow rates on blood carbon dioxide accumulation during THRIVE is unknown. Specifically, very high flow rates, exceeding 70 L/min have not been investigated. Therefore, the aim of this trial is therefore to study the rate of accumulation of carbon dioxide during THRIVE at two different flow rates: 40 and 100 L/min.
Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). The investigators hypothesized that the use of CPAP with EPR is less effective in controlling OSA when compared to CPAP without EPR, applied at the same treatment pressure. The investigators also hypothesized that the CPAP pressure necessary to abolish respiratory events during both manual and automatic CPAP titration with EPR will be greater than the pressure titrated with CPAP without EPR. OSA participants will undergo full polysomnography during CPAP and EPR will be turned on and off in order to test the impact of EPR on airflow and residual AHI.
In this study, which was planned to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in individuals with OSAS; 40 cases over the age of 40 who were diagnosed with severe (AHI: 30 and over) Obstructive Sleep Apnea Syndrome by polysomnography in the Sleep Laboratory of the Department of Chest Diseases of the Istanbul University Istanbul Medical Faculty Hospital will be included. The cases will be divided into two groups with the randomization system and the education of both groups will continue for a total of 8 weeks. In the literature, it is stated that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct therapy to CPAP or oral devices. No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. For this reason, OSAS patients using regular CPAP were planned as two groups in the treatment part of this study. Control Group: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week. Training Group: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.
Drug-induced sleep endoscopy (DISE) used as diagnostic tool but not yet as a therapeutic procedures to manage the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep, there are many aspects that need to be standardized in order to obtain reliable and reproducible information result in cryotherapy at sites of vibration as origin of snoring and site of collapse.
Obstructive sleep apnea syndrome (OSA) is a pathology that affects 2 to 15% of the French adult population and more than 30% of subjects over 65 years old. It consists of repeated collapses of the upper airways during sleep leading to interruptions in ventilation (apneas) or significant reductions in ventilation (hypopneas). Balagny et al. have demonstrated the occurrence of hypertension in patients screened positive for sleep apnea syndrome in a French general population cohort. It is also established that sleep apnea increases the risk of cardiovascular disorders, such as metabolic syndrome (combining abdominal obesity and metabolic disorders), hypertension, heart rhythm disorders, especially at night, atherosclerosis (deposits of atheromatous plaques on the artery walls) or type 2 diabetes. These different complications increase the risk of cardiovascular accidents such as cardiac arrest, myocardial infarction, stroke, and expose to a risk of premature death (Inserm). The treatment of choice is night-time positive pressure ventilation, made possible by the use of a breathing apparatus (Continuous Positive Airway Pressure or CPAP). Alternatives to CPAP are the use of a nocturnal Mandibular Advancement Orthosis (MAO) which advances the jaw and allows a pharyngeal opening, and surgery in selected patients. The phenomenon at the origin of apneas is due to a relaxation of the muscles of the pharyngeal wall located at different heights. This obstruction is favored by anatomical particularities specific to each individual. The clinical examination can detect certain anomalies (enlarged tonsils, obstructive soft palate, prominent tongue base, abnormal epiglottis) and propose surgery to remove the obstruction. Nevertheless, it remains difficult to affirm that the detected anomaly is really at the origin of the obstruction and surgical failures are frequent. Endoscopy under induced sleep has been developed for about 10 years in France. This examination, widely used in the world, remains confidential in France. It consists, in the operating room, in inducing a medicated sleep (specific drugs delivered by an anesthetist) and performing a pharyngolaryngeal fibroscopy. The ENT physician can then visualize "live" the site and origin of the obstruction during an apnea. The main objective is to evaluate the interest of endoscopy under sleep before making a surgical indication in a patient presenting a sleep apnea syndrome. The secondary objective is to evaluate the reliability of sleep endoscopy.
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.