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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT02255539 Completed - Clinical trials for Obstructive Sleep Apnea

Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

Start date: January 2015
Phase: N/A
Study type: Interventional

AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.

NCT ID: NCT02251574 Completed - Clinical trials for Obstructive Sleep Apnea

Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.

NCT ID: NCT02250417 Completed - Clinical trials for Sleep Apnea, Obstructive

Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea

Start date: August 2014
Phase: N/A
Study type: Interventional

Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA. The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.

NCT ID: NCT02247167 Completed - Clinical trials for Obstructive Sleep Apnea of Child

Endothelial Dysfunction and Oxidative Stress in Children With Sleep Disordered Breathing.

Start date: February 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Sleep disordered breathing (SDB) is a common disease in both adults and children and is caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main treatment option is adenotonsillectomy (AT). It is well known that obstructive sleep apnoea (OSA) in adults increases the risk for hypertension, coronary artery disease and stroke, and there is now mounting evidence that SDB also has a significant impact on the cardiovascular system in children with reports of elevated blood pressure, endothelial dysfunction and altered autonomic cardiovascular control. Oxidative stress seems to play a pivotal role in impairing flow-mediated dilation (FMD) and consequently enhancing cardiovascular risk in SDB patients but the underlying mechanism is still undefined. Previously, we demonstrated that endothelial dysfunction is directly related to NADPH oxidase activation. Furthermore, recently we assessed the association between OSA, endothelial dysfunction and oxidative stress in adults showing that increased NADPH oxidase-generated oxidative stress and arterial dysfunction are partially reversed by nasal continuous positive airway pressure treatment. There is evidence in literature that cardiovascular morbidities associated with SDB are potentially reversible in children; AT may have a significant role in reversing the cardiovascular sequelae of SDB (e.g. children with OSA). Nowadays, there aren't studies that analyzed the role of NADPH oxidase-generated oxidative stress in SDB children. The purpose of the current research project is to examine the role of NADPH oxidase activity, oxidative stress, inflammation and endothelial function in SDB children, understanding the mechanisms involved in this disease. Furthermore we will analyse the effect of a AT on inflammation, oxidative stress, NADPH oxidase activity and endothelial function in SDB children.

NCT ID: NCT02244957 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA

Start date: September 2014
Phase: N/A
Study type: Interventional

The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population.The investigators propose to conduct this study that aims: (1) to compare right and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV) hemodynamics in overlap syndrome. This study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia alone in patients with overlap syndrome.

NCT ID: NCT02242617 Completed - Clinical trials for Obstructive Sleep Apnea

Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial

CHOICE
Start date: November 2015
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians. It is the cause of significant healthcare costs with increased morbidity and mortality. The two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance, cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use. Until now, studies have used self-reported adherence data on MAS versus objective adherence on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is counterbalanced by the superior adherence relative to PAP, resulting in a similar effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS and could be used to prove this hypothesis and allow a new and complete comparison of effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's objective adherence and long-term symptomatic improvement would provide vital information to doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will receive both PAP and MAS in a random sequence. This innovative study lead by two experienced new investigators, and a research team of multidisciplinary experts, will assess objective adherence, treatment efficacy, patient preference, sleepiness and quality of life of each treatment used at home for 1 month per treatment. After this, patients will be able to go back and forth between both treatments during an additional 6-month period. The results of this study will be used by healthcare policy makers as well as clinicians who need to be part of the treatment plan decision for the many Canadians who suffer from sleep apnea.

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: NCT02233166 Recruiting - Clinical trials for Obstructive Sleep Apnea

OSA in Children Referred for Adenotonsillectomy

Start date: August 2014
Phase: N/A
Study type: Observational

In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure. There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG). The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy. The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life. The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.

NCT ID: NCT02230085 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Adherence Risk Indicator Validation Study

ARI
Start date: September 2014
Phase: N/A
Study type: Observational

While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.

NCT ID: NCT02227134 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children

Start date: February 2015
Phase: N/A
Study type: Interventional

This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.