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Sleep Apnea Syndrome clinical trials

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NCT ID: NCT02317848 Completed - Heart Failure Clinical Trials

PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure

PROVE-SAS-AHF
Start date: December 2014
Phase: N/A
Study type: Interventional

The prevalence of sleep-disordered breathing is common in patients with stable chronic heart failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS) and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is associated with higher mortality. CHF is associated with a high rate of re-hospitalization and significant morbidity and mortality and is considered as a major medical and economic problem. To date, few studies have investigated the prevalence, severity, persistence and the role of SAS during cardiac decompensation. For different pathophysiological considerations, it is assumed that SAS is exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This assumption has been questioned recently by some studies which showed stability of the type of SAS and its severity between the decompensation episode and the stable HF. Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of severity and type at three months of decompensation. Thus early polygraphy may be reliable for identifying HF patients with SAS.

NCT ID: NCT02316665 Completed - Type 1 Diabetes Clinical Trials

Effect of Sleep Apnea Treatment on Type 1 Diabetes

DIADEME
Start date: April 2013
Phase: N/A
Study type: Interventional

Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal glycemia in patients having type 1 diabetes and sleep apnea syndrome. Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in type 1 diabetic patients and that continuous positive airway pressure treatment will permit to improve the nocturnal glycemic profile. Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of sleep habits and assessment of sleep breathing disorders. When patients will present with severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway pressure treatment or sham-continuous positive airway pressure treatment group for three months. Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three months of the allocated treatment.

NCT ID: NCT02234765 Completed - Clinical trials for Sleep Apnea Syndrome

Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care

GESAP
Start date: May 2014
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. Epidemiological studies in our country have shown that OSA is a highly prevalent disease in the general population, affecting 2-4% of the adult population. The most important clinical manifestations of OSAS is a deterioration in the quality of life and an increase in cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and considering the medical complications of OSA, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. Finally, we have a highly effective treatment using positive pressure in the upper airway (CPAP) that has been shown to be effective and cost-effective. The current situation in which all patients diagnosed with OSA and receiving different treatments are monitored and controlled by the Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our working hypothesis is: "By the coordination of actions at various levels including interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records and the use of new technologies can be achieved in AP satisfactory management of the diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by SU. In addition, management by AP will be more cost-effective than in the SU."

NCT ID: NCT02148432 Completed - Clinical trials for Sleep Apnea Syndrome

Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome

Start date: May 19, 2014
Phase: N/A
Study type: Interventional

Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis. This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.

NCT ID: NCT01752556 Completed - Clinical trials for Sleep Apnea Syndrome

Cost-effectiveness of Home Respiratory Polygraphy

HRP-M
Start date: May 2012
Phase: Phase 3
Study type: Interventional

Primary objectives: The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale; Secondary Objective: 1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. 2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques

NCT ID: NCT01259154 Completed - Clinical trials for Sleep Apnea Syndrome

Combined RF Surgery of the Tongue Base and Uvulopalatopharyngoplasty (UPPP) for Obstructive Sleep Apnea

Start date: n/a
Phase: N/A
Study type: Observational

Introduction: The aim of the study was to investigate the effectiveness of combined bipolar radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a single session for obstructive sleep apnea (OSA) and to determine whether this combination is safe and well tolerated.

NCT ID: NCT01164631 Completed - Malocclusion Clinical Trials

Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Start date: November 2006
Phase: Phase 4
Study type: Interventional

Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.

NCT ID: NCT01071421 Completed - Infections Clinical Trials

Sleep Apnea Syndrome and Community Acquired Pneumonia

NEBULOSA
Start date: April 2006
Phase: N/A
Study type: Observational

The association of sleep apnea-hypopnea syndrome (SAHS) with the infections of the lower airway has not been studied. The aspiration of secretions of the upper airway and the colonization by microorganisms is considered a main event in most of the cases of community acquired pneumonia (CAP) , and specially in the nosocomial pneumonia. The silent aspiration to the lower airway is a common phenomenon in normal subjects during the sleep and some studies has reported that the patients with SAHS present an increase of the risk to pharyngeal aspirations. In fact, the presence of nasal and bronchial inflammation in patients with SAHS is a recognized event. The patients with SAHS could have a risk increased to develop pneumonia due to predisposition to the pharyngeal microaspiration to lower airways during the sleep and other mechanical factors associated. The prevalence of SAHS in patients with CAP could be increased as regards the data published for the same Spanish population. The presence of an apnea-hypopnea index (AHI) could be a risk factor not only to to CAP but to to present a unfavorable clinical evolution in comparison to patients with CAP with a normal AHI. The aim of this study will establish a relation between SAHS and the pneumonia risk.

NCT ID: NCT00952172 Completed - Clinical trials for Sleep Apnea Syndrome

Stair Stepping Exercise Training in Patients With Obstructive Sleep Apnea Syndrome

Start date: August 2006
Phase: Phase 2
Study type: Interventional

This 3-year prospective, randomized, control, longitudinal study is aimed to (1) examine the effect of stair stepping exercise training on cardiopulmonary fitness and sleep situation in patients with Obstructive Sleep Apnea Syndrome (OSAS), and (2) follow the longitudinal change after stair stepping exercise training in patients with OSAS. Patients meet the following criteria will be invited to participate in this study: being diagnosed with AHI (Apnea-hypopnea index)>15/hr and ODI (oxygen desaturation index)>10/hr by Polysomnography, aged 19 or older. Based on the power analysis, 70 patients with OSAS treated in the outpatient department of Chang Gung Medical Center will be recruited over a period of 26 months. Each patient will participate in this study for seventeen weeks. Patients will be randomly assigned to receive stair stepping exercise in addition to nursing education and standard care, or nursing education and standard care alone. Stair stepping exercise will be performed at home daily for eight weeks. Outcomes will be determined by changes in the scores of cardiopulmonary fitness index, VO2max, six-minute walking distance, daytime sleepiness measured by Epworth Sleepiness Scale, sleep time measured by Actigraphy, and AHI measured by Polysomnography; those taken four times: before treatment (baseline), five weeks, nine weeks, and seventeen weeks of the study. Data will be analyzed using descriptive statistics and Generalized Estimating Equation (GEE).

NCT ID: NCT00942669 Completed - Clinical trials for Sleep Apnea Syndrome

Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)

Start date: August 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.