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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT01466218 Completed - Clinical trials for Obstructive Sleep Apnea

World Trade Center (WTC) CHEST

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

This project will evaluate the effects of World Trade Center (WTC) exposure in WTC responders 10-13 years following the events of 9/11. Prior studies have described persistent pulmonary function abnormalities in a significant portion of responders. The investigators study seeks to examine the relationship between pulmonary function abnormalities and other markers of chronic cardiopulmonary disease and further elucidate the pathophysiologic effects of exposure to inhaled particulate matter (PM) on 9/11. This study will provide critical information regarding risk of exposure to PM, risk factors for disease and potential for improvements in diagnosis and treatment.

NCT ID: NCT01462409 Completed - Clinical trials for Sleep Apnea, Obstructive

Humidity Under Continuous Positive Airway Pressure

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

Heated humidification in CPAP therapy is often not enough to prevent side effects like dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask leakage. Additionally a higher level of humidification in lower ambient room temperature can lead to condensation and irritating noises. Compliance of affected patients decreases considerably. Regarding this, devices with humidifier and additional heated tubing are developed to automatically regulate optimal humidification and temperature right up to the mask. The efficacy of a system with controlled heated humidification and heated tubing in nasal masks under various conditions like leakage and different pressure levels is object of this study.

NCT ID: NCT01462084 Completed - Clinical trials for Obstructive Sleep Apnea

Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use

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

Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications

NCT ID: NCT01461486 Completed - Clinical trials for Mild Obstructive Sleep Apnea Syndrome

Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea

OSAS
Start date: October 2011
Phase: N/A
Study type: Interventional

Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.

NCT ID: NCT01461473 Completed - Clinical trials for Sleep Apnea, Obstructive

Comparative Outcomes Management With Electronic Data Technology (COMET) Study

COMET
Start date: December 2011
Phase: Phase 3
Study type: Interventional

STAGE I of the COMET study is to develop an Electronic Network Informatics Infrastructure that will prospectively enable access to and the sharing of clinical and research data. STAGE II: This is a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study will be incorporated in Part 3 of the STAGE I study. STAGE III of the COMET study is completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We will also explore expanding ontologies, and the use of federated database methodology.

NCT ID: NCT01460173 Completed - Clinical trials for Sleep Apnea, Obstructive

Divided Attention Steering Simulator Alertness Test

DASS
Start date: February 2011
Phase: N/A
Study type: Interventional

Driving simulator programmes are used under a wide range of conditions, and a correlation of driving performance and real accident risks in patients with obstructive sleep apnoea syndrome(OSAS)could be shown. The most frequently used driving simulator is the Divided Attention Steering Simulator (DASS) of Stowood Scientific Instruments Ltd. (SSI). Until today there are no reference levels with regards to sex and age in existence. To define the boundaries of normality age and sex reference values are to be generated and compared to values of patients with OSAS. 50 male and 50 female healthy subjects (10 of each age decade between 20 and 70 years) will perform the DASS for 30 minutes. In the other arm 100 OSAS Patients will perform the test as well. A better differentiation of pathologic driving performance and response times of OSAS patients should be possible with new reference levels.

NCT ID: NCT01457729 Completed - Clinical trials for Obstructive Sleep Apnea

Ergometer Training in Patients With OSA

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

Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour.

NCT ID: NCT01450540 Completed - Clinical trials for Obstructive Sleep Apnea

Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients

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

Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.

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: 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.