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Sleep Apnea clinical trials

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NCT ID: NCT01124370 Completed - Sleep Apnea Clinical Trials

Chronic Evaluation of Respicardia Therapy

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias. The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study. It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.

NCT ID: NCT01115686 Withdrawn - Sleep Apnea Clinical Trials

Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

ARSAS
Start date: June 2010
Phase: Phase 3
Study type: Interventional

The initial hypothesis is that branched-chain aminoacids (BCAA) administration could be beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work is to verify this hypothesis. The literature data demonstrate that a BCAA complementation improves the physical performances, protects lean mass and increases VO2 max during training. We demonstrated earlier that this complementation can cure at less partly the hypoxemia of chronic obstructive pulmonary patients by a stimulation of respiratory centres.

NCT ID: NCT01108081 Completed - Sleep Apnea Clinical Trials

Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.

NCT ID: NCT01099735 Completed - Sleep Apnea Clinical Trials

Effect of Continuous Positive Airway Pressure (CPAP) on Lower Esophageal Sphincter Pressure in Morbidly Obese Patients

Start date: January 2010
Phase:
Study type: Observational

This trial is enrolling patients who are already being seen at OHSU weight loss clinic or have been referred for clinical reasons by their physician to the OHSU weight loss clinic and are going to have a esophageal manometry that would be paid for by their insurance company for clinical reasons. In patients undergoing weight loss surgery investigators plan to study the effect of continuous positive airway pressure during a esophageal manometry.

NCT ID: NCT01096433 Completed - Sleep Apnea Clinical Trials

Circadian Variations of Prostaglandin in Sleep Apnea

Start date: May 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

NCT ID: NCT01047709 Completed - Stroke Clinical Trials

Positional Therapy After Stroke

Start date: December 2008
Phase: Phase 2
Study type: Interventional

Stroke is the leading cause of adult disability and the third leading cause of death in the United States. Unfortunately, there are few therapies that have been proven to improve stroke outcome. Sleep apnea is an emerging stroke risk factor and has a well established association with higher mortality and poor functional outcome following stroke. Over half of acute stroke patients have sleep apnea, suggesting that it may be a important target for therapy. Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the standard treatment for sleep apnea is not well-tolerated among stroke patients. An alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute stroke patients, and therefore this treatment may have particular relevance to the stroke population. The proposed study will be conducted in two phases. The first phase is a randomized, crossover design in which acute stroke patients will be given positional treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will be compared with another night of sleeping without positional therapy. The order of treatments (standard vs positional therapy) will be random. The first phase will demonstrate the proof of concept: that stroke patients given positional therapy to avoid supine sleep will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with positional therapy. In the second phase, those identified to have sleep apnea will be randomized to receive positional therapy at home for three months, or standard therapy. This second phase will demonstrate the adherence/feasibility of three months of positional therapy, and will allow us to estimate effect size based on a functional outcome measure. The data obtained from this pilot clinical trial are essential to plan a large efficacy study.

NCT ID: NCT01026103 Completed - Hypertension Clinical Trials

Tri Staple Technology Stapler Used in Gastric Bypass

Start date: January 2010
Phase: N/A
Study type: Interventional

The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.

NCT ID: NCT01015872 Completed - Sleep Apnea Clinical Trials

The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the relationships between prostanoids and various outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

NCT ID: NCT00997165 Recruiting - Atherosclerosis Clinical Trials

Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort

NUMEVOX
Start date: March 2008
Phase: N/A
Study type: Observational

The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in relation to adipose tissue repartition in patients with metabolic syndrome associated to liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering the cohort.

NCT ID: NCT00989885 Completed - Sleep Apnea Clinical Trials

ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea

Start date: January 2007
Phase: N/A
Study type: Observational

The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.