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Obstructive Sleep Apnea of Adult clinical trials

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NCT ID: NCT03940781 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.

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: 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.

NCT ID: NCT03243487 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

ThErapy Adherence Management in Veterans

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

The study is a prospective, randomized, controlled trial studying adherence to positive airway pressure therapy in a population referred to the VA system for the treatment of sleep disordered breathing. The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting Centers for Medicare & Medicaid Services (CMS) adherence requirements (use > 4 hours for >= 70% of days) at 90 days.

NCT ID: NCT03156283 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive airway pressure (PAP) therapy is the treatment-of-choice and "gold standard" for individuals with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent disease and improve quality of life. Nevertheless, PAP adherence rates are low. Most PAP adherence programs do not address the self-management skills and strategies that promote adherence and are often too costly and complex to integrate into overburdened clinical environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical activity), which have promise to improve OSA symptoms and PAP adherence. The investigators have previously developed and successfully tested BeWell24, a multicomponent smartphone "app" that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical activity behaviors. The investigators will enhance this app to create SleepWell24. Enhancements will include: (1) specific behavior change strategies from the evidence-based Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange of patient data to facilitate patient-provider communication on treatment progress; and (3) real-time feedback via wireless integration with a consumer-based PAP machine and wearable sensor. All aspects of this work will be embedded within the Mayo Clinic Arizona Center for Sleep Medicine. The investigators will test the effects of SleepWell24 in newly prescribed PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared to a usual care control group. The investigators will conduct a pilot randomized controlled trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days post-PAP prescription. The investigators will track recruitment/retention rates, app usage statistics, and measures of treatment satisfaction. The investigators will objectively measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP usage compared to the usual care group. In an exploratory fashion, the investigators will also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime sleepiness, cognitive impairment, and health-related quality of life) and evaluate social cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence.

NCT ID: NCT03122639 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

Endothelial Function in Obstructive Sleep Apnea

Start date: September 1, 2017
Phase: Early Phase 1
Study type: Interventional

Obstructive sleep apnea (OSA), a condition that affects a quarter of the Western adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Intermittent hypoxia (IH) during transient cessation of breathing in OSA leads to endothelial inflammation, a key step in the initiation and progression of cardiovascular disease. However, the mechanisms that mediate IH-induced endothelial inflammation remain unclear and, consequently, no targeted therapy is available for vascular manifestations of OSA. Using endothelial cells (ECs) freshly harvested from OSA patients, they study team has identified impaired complement inhibition as an initial stimulus for endothelial inflammation in IH, thereby linking for the first time complement activation to vascular risk in OSA. The investigators found that a major complement inhibitor cluster of differentiation (CD59), a plasma membrane protein that inhibits the formation of the terminal complement membrane attack complex (MAC) and protects host cells from complement injury, is internalized from the EC surface in OSA patients. Consequent MAC deposition initiates endothelial inflammation in IH. Importantly, the investigators showed that IH does not significantly affect inflammation in ECs in the absence of complement, suggesting that complement activation has an essential role in endothelial inflammation in OSA. Interestingly, internalization of CD59 in IH appears to be cholesterol-dependent and statins prevent MAC deposition on ECs in IH in a CD59-dependent manner, suggesting a novel therapeutic strategy to reduce vascular risk in OSA. This led the study team to hypothesize that IH-induced cellular cholesterol accumulation reduces complement inhibition via increased internalization of CD59 from the EC surface leading to increased MAC deposition, and that treatment of OSA with continuous positive airway pressure (CPAP) and/or statins reverses endothelial dysfunction by restoring complement inhibition.

NCT ID: NCT03091894 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

Start date: April 9, 2017
Phase: Phase 4
Study type: Interventional

This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

NCT ID: NCT03070769 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

Start date: June 1, 2012
Phase: N/A
Study type: Observational

The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of OSA patients and to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters. Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group. Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between groups.

NCT ID: NCT03063567 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

Investigation of Predictive Indices to Objectively Guide Choice of CPAP Interface

Start date: August 2014
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a prevalent disease, and one that is associated with significant negative impact on long-term survival. There is convincing evidence that treatment of OSA can improve outcome in patients with cardiovascular disease, improve blood pressure and blood glucose control, and improve the overall metabolic syndrome. Treatment is usually with continuous positive airway pressure (CPAP). However, many patients face problems with their CPAP interfaces, affecting their compliance and response to treatment. Proper mask fit is important in decreasing air leak and increasing comfort, thus leading to better compliance. Currently, the choice of interfaces depends mainly on the experience of the sleep disorder unit (SDU) technicians. Unsuitable choice of interface not only affects response to treatment but also increases medical costs when interfaces need to be replaced to better fitting ones. It is thus important to develop selection criteria to objectively guide the SDU technicians in choosing the suitable interfaces. The objective of this study is to study the facial profile of patients and look for predictive indices that can be used to objectively guide the choice of appropriate interfaces. Frontal and side profile photographs of patients will be taken and facial measurements will be recorded. Patients will then be given a one monthly trial of each of the 3 interfaces (nasal masks, oronasal masks, nasal cushions) in a randomised order. The patients' subjective perception of each of the interface will be assessed and patients will nominate their preferred interface at the end of the trial. The amount of leak and the hours of adherence for each type of interface will also be analysed. A multinomial logistic regression analysis will then be done to look for facial measurements that will predict the interface that patients will be most satisfied with. Hypothesis That measurement of facial structures and clinical features will be able to predict the best-fit CPAP interface for each patient. Study Objective - To determine anthropometric facial measurements and clinical factors important in achieving a good interface fit for each patient - To derive a prediction rule or equation that will be able to accurately predict which interface a patient should be prescribed

NCT ID: NCT03048604 Completed - Clinical trials for Obstructive Sleep Apnea of Adult

BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

Start date: March 30, 2017
Phase: N/A
Study type: Interventional

The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).