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Apnea clinical trials

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NCT ID: NCT01455077 Recruiting - Obesity Clinical Trials

Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients

Start date: January 2011
Phase: N/A
Study type: Observational

Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities. However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population. Objective: To evaluate the accuracy of level III type of PMS - Stardustâ„¢" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA. Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings: 1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.

NCT ID: NCT01447251 Completed - Diabetes Mellitus Clinical Trials

Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed With Obstructive Sleep Apnea

OSA & DM
Start date: September 2011
Phase: N/A
Study type: Interventional

The investigators plan to recruit 140 patients (35 subjects in each group) over a period of 18 months in a prospective study of matched/paired case-control subjects across the four groups to measure the 5-year risk of developing DM2 in each group and if knowledge of the 5-year risk of developing diabetes will affect continuous positive airway pressure (CPAP) compliance. The study will have four arms: 1) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are given the result of the diabetes risk score; 2) patients who have newly-diagnosed OSA requiring CPAP therapy without diabetes and are not given the result of the diabetes risk score; 3) age, sex, and BMI-matched controls without OSA or diabetes; 4) age, sex, BMI, and OSA severity matched patients on CPAP therapy for OSA. The investigators will document that the patients are compliant with CPAP based on review of SD card data recorded by the CPAP machine. Each patient will have serum drawn for the biomarker panel as well as the standard diagnostic measures of DM2 (oral glucose tolerance test (OGTT) upon enrollment in the study. An Epworth Sleepiness Score, BMI, neck and waist circumference, smoking history, blood pressure, and other standard vital signs will also be collected. There will be no follow-up of the study subjects in groups 3 and 4 and their participation in this study is completed after Visit 1. Groups 1 and 2 will be followed for 6 months after enrollment to assess whether or not there is any change in CPAP compliance as measured by SD card.

NCT ID: NCT01446601 Terminated - Clinical trials for Obstructive Sleep Apnea

Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

NCT ID: NCT01441622 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome

AL539
Start date: June 2011
Phase: N/A
Study type: Interventional

Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS). The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.

NCT ID: NCT01435486 Completed - Bronchiolitis Clinical Trials

Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants

Start date: November 2011
Phase: N/A
Study type: Interventional

Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central respiratory drive. Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September 2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea. A randomized, double-blind, controlled trial with a sample size of 45 patients per group Data Collection methods, instruments used measurements: Randomization: In the emergency department, the patients will be assigned to either one of the two treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will prepare sequential sealed vials containing the experimental drugs. Randomization code will be revealed only after all patients completed the study. The medical team in addition to the patients will be blinded to the medication delivered. There will be no detectable difference in the color, smell of the two study treatments. Guardians or parents of eligible infants will be approached regarding the study, explaining the purpose and the treatment modalities. Patients will be included after obtaining a verbal and written consent. Study Intervention: Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base). Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30 minutes using syringe infusion pump. After random assignment, eligible infants will receive one of the study treatments. Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and antipyretics may be used as per the discretion of the treating physician. After stabilization of patients as usually done in Pediatric Emergency Center , patients will be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when indicated.

NCT ID: NCT01431157 Terminated - Heart Failure Clinical Trials

Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure

Start date: November 2011
Phase: N/A
Study type: Interventional

Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias, pulmonary hypertension, heart failure, and premature death. There is significant evidence suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of the abnormalities associated with this disease. Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild sleep apnea is present in 17% of adults in the general population and moderate to severe sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to be anywhere from 11-53% in heart failure patients. Continuous positive airway pressure (CPAP) therapy is currently the standard of care for sleep apnea sufferers regardless of the severity of their disease. In patients without heart failure, CPAP therapy has numerous benefits and several long term studies have reported that CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular symptoms and mortality among patient with severe sleep apnea. In heart failure patients, CPAP has shown some beneficial short term effects but evidence of long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is often poor and many people cannot tolerate it. This further limits the therapeutic effectiveness of this intervention. The purpose of this study is to assess whether nocturnal oxygen administration via nasal cannula alone can improve outcomes in congestive heart failure patients with moderate to severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using biomarkers of heart stress and markers of whole body inflammation.

NCT ID: NCT01428570 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Comparison of the Pentax AWS® With the Macintosh Laryngoscopic Intubation in Obstructive Sleep Apnea Syndrome Patients

Start date: August 2011
Phase: Phase 4
Study type: Interventional

The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.

NCT ID: NCT01426607 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea

VASO-AM
Start date: March 2011
Phase: N/A
Study type: Interventional

This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.

NCT ID: NCT01424592 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)

Start date: April 2011
Phase:
Study type: Observational

Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA is accurate in determining the need for positive airway pressure (PAP) therapy when compared to outpatient laboratory-based polysomnography. - Hospitalized medical inpatients referred for suspected OSA will be tested with a portable sleep apnea testing device during hospitalization. - These patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge. - Results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.

NCT ID: NCT01422863 Completed - Clinical trials for Obstructive Sleep Apnea

Lifestyle Interventions for Seniors With Apnea

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

The overall goal of this study is to determine the efficacy of a lifestyle intervention, consisting of a weight loss diet and exercise on sleep apnea in older adults. The investigators will conduct a 3-month intervention in men and women who are sedentary with suspected sleep apnea. The investigators hypothesize that the intervention will lead to marked improvements in sleep apnea severity and cardiovascular risk markers.