Active clinical trials for "Sleep Apnea, Obstructive"

Obstructive sleep apnea (OSA) is a common disease that is largely un-diagnosed and untreated. Standard treatment for obstructive sleep apnea, nasal continuous positive airway pressure (CPAP), entails use of a nose mask to deliver positive pressure which dilates the pharynx and eliminates obstruction. This therapy is highly efficacious and benign but is associated with low adherence, particularly in non-sleepy apneics with disease of mild and moderate severity. The principal alternative to CPAP therapy is oral appliance (OA) therapy in which a custom made mandibular advancement splint (MAS) is used to protrude the mandible during sleep, thereby opening the pharyngeal airway. OA therapy, while preferred and well accepted by most participants, is not uniformly efficacious. Additionally, uncertainty regarding the patient's response to OAT and the effective target mandibular position can lead to a significant time span between diagnosis and initiation of effective treatment. Furthermore, knowledge of the effective target mandibular position supports the use of new OA design and manufacturing processes that can further reduce the time and cost in delivering the therapy. Zephyr Sleep Technologies (the Sponsor) has developed a method of identifying OAT responsive participants and their efficacious mandibular protrusion. Recently, Zephyr Sleep Technologies developed a portable device that avoids this requirement and can be used in a multi-night test in the home. Using a feedback controlled mandibular positioner (FCMP), the device measures and analyzes respiratory airflow and oxygen saturation and makes decisions in real-time about moving the mandible. The FCMP device was tested in a blinded, bi-phase clinical study in which participants with mild-to-severe sleep apnea (n=202) underwent two full-night studies in the home. Data from phase 1 were used to develop a predictive method, and data from phase 2 were used to prospectively test the accuracy of the predictive method. An efficacious mandibular position was also predicted, and each participant was treated with a custom oral appliance set to that position. Data from both phases were used to evaluate the feasibility of use of the device in the home. A random forest machine learning system was used to develop and test the predictive method. The overall oral appliance success rate was 76% for phase 1 and 71% for phase 2. The overall predictive accuracy was 88%. Values for sensitivity and specificity were 85% and 93%, respectively. Positive and negative predictive values were 97% and 72%, respectively. The effective target protrusive position was identified in 86% of cases. The studies were conducted independently by the participants in their homes, though due to limitations in the early prototype design, a clinical coordinator visited the home to set up the equipment prior to each night of study. No significant problems were encountered, and no significant risks were identified. The results of the clinical trial show that the auto-titrating mandibular positioner is suitable for use in the home and accurately predicts OAT outcome as well as target protrusive position. Based on the results of this study, Zephyr developed a commercially available device which has been approved for sale in Canada (Health Canada device license #97614). The device, branded MATRx plus, functions as both a sleep recorder as well as a home-based system to select patients for oral appliance therapy. This commercially available device is currently being used in three separate usability trials to quantify the usability of the device and the benefits of an improved workflow through adoption of the new technology in a dental practice. Evidence has recently appeared to indicate that the change in pharyngeal volume caused by protrusion of the mandible, measured while awake, correlates with the change in apnea-hypopnea index (AHI) achieved by OAT, measured while asleep. This is the first convincing evidence that an awake measurement of the pharyngeal airway correlates with the improvement in respiratory status during sleep induced by an oral appliance. The implication is that a simple conebeam CT of the pharynx can predict outcome with OAT. Accordingly, we shall carry out conebeam CTs in the research protocol, both at rest position of the mandible and at 90% of maximal protrusion. The purpose of this study is to test whether the predictive accuracy of the FCMP in the home environment is improved by the commercial design and whether patients predicted to be suitable for oral appliance therapy have long term adherence.

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.

Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Obstructive sleep apnea (OSA) is a common disorder with serious complications. Positive airway pressure (PAP) is the first line treatment of OSA, which eliminates obstructive events, reduces daytime sleepiness, and improves quality of life, especially in those with excessive daytime sleepiness. However, despite the benefits of the PAP treatment, overall acceptance and adherence rates are not fully promising. Less is known regarding the PAP adherence rates in Turkey. In the current study, the researchers primarily addressed if an intensified patient education strategy including the polysomnography (PSG) charts viewing followed by frequent follow-ups would improve the compliance rates at long-term in patients with OSA.

This project develops a new form of management of subjects with suspected SAHS and different sleep disorders by applying Information and communications technologies (ICT).

Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence exists that some behavioral (e.g. exercise based) therapies may assist in lessening the severity of this disorder. The proposed investigation will examine the effects of eight weeks of genioglossus muscle strength training on measures of snoring and OSA severity as well as genioglossus protrusive muscle strength.

This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.

In recent years medicine has been enhanced by the incorporation of technological innovations from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering. One of the few exceptions in this rapid process of implementing technological advances occurs in clinical medicine, where its penetration is much less effective than in other scientific and professional fields, or even in everyday life. Attempts to tackle this problem have given rise to various initiatives in the US and Europe, including Spain. There is a surprising paucity of telemedicine systems in clinical practice, especially with respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea (OSA), where protocols are urgently needed to alleviate this healthcare problem represented by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In others words, the growing awareness of sleep disorders, especially OSA, has not been accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these diseases. CPAP therapy compliance is not always appropriate. Helping patients during the first two months usually determines compliance. Therefore, the development of strategies to support the patient during the first weeks is essential. However, this "collides" with reality, where it is difficult to properly care all patients because of congested sleep units. It is therefore necessary to implement new and imaginative control schemes especially at the beginning of the treatment. Patients' follow-up performed by telemedicine technology is an option that aims to substitute the face-to-face visits or at least reduce them considerably. In a future context, the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda face-to-face visits and televisits (at distance) and information which patient will provide through online questionnaires with a certain frequency. In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients monitored by telemedicine techniques (website and televisits) is similar to that achieved by standard monitoring but more cost-effective. The study design is a multicenter randomized trial with parallel groups and blind final evaluation after CPAP treatment following two different strategies: one through conventional monitoring in the hospital (face-to-face visiting) and another by telemedicine monitoring (non-contact visiting and website).