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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03383887 Completed - Clinical trials for Obstructive Sleep Apnea (OSA)

DAW1033D in Obstructive Sleep Apnea

OSAstimD
Start date: December 13, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.

NCT ID: NCT03381508 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Air Leakage Under Continuous Positive Airway Pressure

SAS-leak-1
Start date: January 10, 2018
Phase:
Study type: Observational

The software embedded in recent continuous positive pressure devices enables the analysis of the level of leakage that occurs during treatment around the mask or from the mouth. However, there is no clear threshold defining when it would be appropriate to implement means for correcting these leaks. In addition, the calculation methods used to detect/measure leaks and the terminology used vary according to the manufacturers of continuous pressure devices, which also complicates the clinical interpretation of the leakage reports provided by the various devices. In daily practice, when a patient complains of unintentional leakage, technicians adjust the mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those strategies are not always effective in reducing leakage or patient's complaints. A better understanding of the mechanisms beyond leak appearance for a given patient could lead to individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory effort, sleep position or sleep stages may contribute to leak emergence. A recent exploratory study has proposed a genuine analysis method of determining factors of unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional leakage during auto-CPAP treatment and providing an etiological analysis of unintentional-leaks via a software named APIOS. Due to the innovative nature of the analysis, it appears necessary to validate it onto a population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no descriptive data of the distribution of the determinants of unintentional leaks in such a population. From this perspective, the investigators aim to retrospectively analyse some polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with auto-CPAP. The primary objective of this study is to identify and describe the determinants of unintentional leaks for a population of patients with OSA and treated with an auto-CPAP device

NCT ID: NCT03375905 Completed - Clinical trials for Obstructive Sleep Apnea

Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea

Start date: December 7, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.

NCT ID: NCT03362385 Completed - Clinical trials for Acute Coronary Syndrome

OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients

Start date: May 2015
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. Compared to the general population, OSA occurs more often in patients with acute coronary syndrome (ACS). Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index ACS remain suboptimal. Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular events in ACS patients. However, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been postulated. Due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of OSA with short- and long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the investigators will assess the potential mechanisms of OSA-induced atherosclerosis and myocardial injury in ACS patients.

NCT ID: NCT03359096 Completed - Clinical trials for Obstructive Sleep Apnea

Hypoglossal Nerve Stimulation on Cardiovascular Outcomes

CARDIOSA-12
Start date: December 13, 2017
Phase: N/A
Study type: Interventional

A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

NCT ID: NCT03356106 Completed - Clinical trials for Sleep Apnea, Obstructive

Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy

Start date: November 16, 2016
Phase: N/A
Study type: Interventional

This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.

NCT ID: NCT03336515 Completed - OSA Clinical Trials

Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)

POSTURAL
Start date: September 1, 2015
Phase: N/A
Study type: Interventional

The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apnea (OSA).

NCT ID: NCT03334331 Completed - Clinical trials for Obstructive Sleep Apnea

Validation and Reproducibility of the Six-minute Step Test in Individuals With Obstructive Sleep Apnea Treated With CPAP

Start date: December 4, 2017
Phase:
Study type: Observational

Introduction: The Obstructive Sleep Apnea (OSA) is characterized by obstructed superior airway during sleeping period promoting intermittent hypoxia-reoxygenation events. These events cause consequences such as cardiorespiratory and peripheric muscle structure alterations, which can cause reduction of the exercise tolerance. In this sense the continuous positive airway pressure (CPAP) is important to decrease the repercussions of the illness and cooperate to maintain the exercise functional capacity. To measure this capacity, one good option is the six-minute step test (6MST), that is low cost and submaximal, in addition to being adaptable and portable. However, there are doubts if it´s really capable to determinate the functional capacity of exercise of individuals with OSA treated with CPAP. Objective: Evaluate the validity and reproducibility of 6MST to determine the functional capacity of exercise in individual with OSA treated with CPAP and develop a model of a reference equation for the performance of the test in this population. Material and methods: This is an observational, prospective and cross-sectional study, in which will be evaluated 132 volunteers (66 men and 66 women), with age between 18 and 65 years, diagnosed with OSA of moderate and severe degree, treated with CPAP for a minimum of three months, recruited of the ambulatory of pneumology of Otávio de Freitas Hospital. Initially will be collected personal and anthropometric information, answered to sleep questioners, quality of sleep and physical exercise, also respiratory muscle strength and lung function. The realization of the tests to evaluate the functional capacity of exercise will be done in two days with a maximum of seven days between the tests. In each day, the volunteers will do two 6MST and two six-minute walk test (6MWT), which order will be determined by randomization. Expected Results: It is expected that the 6MST to be showed as reproducible and capable to quantify the functional capability of exercise in individuals with OSA treated with CPAP.

NCT ID: NCT03329352 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Start date: November 3, 2017
Phase: N/A
Study type: Interventional

The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

NCT ID: NCT03325153 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

Obstructive Sleep Apnea and Bronchoscopy

Start date: December 27, 2016
Phase:
Study type: Observational

The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA) remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly. Patients with undiagnosed OSA may experience obstructive episodes during procedures with conscious sedation. STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with moderate to severe OSA. Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a screening questionnaire, and to determine whether the questionnaire could predict patients who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.