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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT01369576 Completed - Clinical trials for Obstructive Sleep Apnea

Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea

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

The clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia. Outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent trial of eszopiclone. This size is expected to be able to discern an important difference of 80 minutes per night. In the current clinical population newly prescribed CPAP at Mount Sinai Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD 2:59) hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in usage per night, including entirely non-adherent patients who do not use treatment at all as 'zero hour' users, would require randomization of 264 patients (132 per group). Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be improved by initial prescription of a common hypnotic, zopiclone. To answer this question we intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician (ABSM or by a respirologist with extensive sleep medicine experience) with supportive polysomnography results who are willing to initiate long-term CPAP treatment.

NCT ID: NCT01368952 Completed - Clinical trials for Obstructive Sleep Apnea

The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea

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

Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI) and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.

NCT ID: NCT01366625 Completed - Hypertension Clinical Trials

Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

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

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.

NCT ID: NCT01365832 Completed - Clinical trials for Obstructive Sleep Apnea

Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)

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

C-reactive protein (CRP) is directly implicated in atherogenesis and associated cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and thus consequently improve disease-related cardiovascular morbidity. However, the influence of gender on the CRP evolution pattern has never been assessed before. The aim of our study was to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months after the start of effective CPAP treatment.

NCT ID: NCT01362777 Completed - Metabolic Syndrome Clinical Trials

Rehabilitation Program as an Alternative Therapy for Moderate to Severe Obstructive Sleep Apnea Syndrome

Rehsolvas
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of traffic accidents but also other cognitive disorders with significant impact on quality of life. OSAS generates oxidative stress, inflammation and resistance to insulin and other systemic metabolic dysregulation of many whose levels are correlated with the severity of the disease. Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept and/or poorly tolerated, limiting its effectiveness. Weight loss and regular physical activity are clearly recommended but rarely done in clinical practice. A few studies have applied to study the effects of rehabilitation training (REE) on the sleep apnea patients and have shown an improvement in sleep quality, reduction of awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their methodology was questionable, and the number of patients included was too low. The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program comprising educational activities, dietary management and individualized exercise training (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL). This IET program (24 sessions during 4 weeks) could also help to improve many metabolic dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk). Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may play a role in enabling a better control of ventilation in these patients.

NCT ID: NCT01355419 Completed - Clinical trials for Obstructive Sleep Apnea

Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP

Start date: August 2010
Phase: N/A
Study type: Observational

In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.

NCT ID: NCT01344759 Completed - Clinical trials for Sleep Apnea, Obstructive

Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

Start date: June 2009
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan. The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.

NCT ID: NCT01340781 Completed - Clinical trials for Obstructive Sleep Apnea

Screening Tools for Obstructive Sleep Apnea (OSA) in Hospitalized Medical Patients

STOMP
Start date: February 2012
Phase: N/A
Study type: Observational

The prevalence of obstructive sleep apnea (OSA) in patients admitted to the hospital is likely significantly higher than the general population as hospitalized patients carry a high prevalence of co-morbid conditions, such as diabetes and cardiovascular diseases, that are commonly associated with OSA. The true prevalence of OSA in hospitalized patients is not known, though there is limited data suggesting that the rate of OSA in hospitalized patients is indeed high. Two studies have reported on the rate of polysomnographic (PSG) diagnosis of OSA in patients referred for OSA evaluation while in-hospital. These studies reported frequencies of 77% (in a retrospective study of 100 patients) and 88-100% (in an observational study of 250 patients). Similarly, 2 studies evaluated the prevalence of sleep disordered breathing in patients admitted with acutely decompensated heart failure, finding frequencies of sleep apnea in 97% (prospective study of 29 patients studied with PSG) and 75% (prospective study of 395 consecutive patients studied with portable monitors). However, all of these studies are limited by either study design (retrospective), small numbers, limited channel portable monitoring, or evaluations of highly select patient populations. Furthermore, none of these studies examined screening tools that may help to identify which patients are at risk for OSA and thus might require the more extensive and expensive objective testing. This study will test the following hypotheses: 1. The prevalence of OSA in unselected hospitalized medical patients will be more than 50% of the study population. Specific Aim 1: To determine the prevalence of OSA in a group of unselected hospitalized medical patients by a combination of sleep symptoms and PSG performed while in-hospital. 2. Screening tools will be able to accurately identify OSA in hospitalized medical patients. Specific Aim 2: To determine the accuracy of different screening questionnaires for the diagnosis of OSA in hospitalized medical patients by comparing the questionnaire results to that of a PSG performed while in-hospital.

NCT ID: NCT01335854 Completed - Clinical trials for Obstructive Sleep Apnea

Promoting Continuous Positive Airway Pressure (CPAP) Adherence

Start date: September 2011
Phase: Phase 0
Study type: Interventional

The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3 groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least 4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and quality of life will evaluate whether patients provided web-based access to their daily CPAP adherence with and without financial incentive will have greater objectively measured average daily hours of CPAP use and greater improvement in functional outcomes following 3 months of treatment compared to patients receiving usual care. The results will test the hypothesis that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.

NCT ID: NCT01335594 Completed - Clinical trials for Sleep Apnea, Obstructive

Evaluation of Swallowing in Patients With Obstructive Sleep Apnea

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

The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.