Active clinical trials for "Sleep Apnea Syndromes"

Background: Obstructive sleep apnea (OSA) is a sleep disorder that commonly occurs in Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental health, poor physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces the many negative health consequences of the disease. However, adherence to PAP is required to reap the therapeutic benefit. Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is part of the standard of care for OSA treatment with PAP, but on its own is insufficient for improving PAP adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT) which have been shown to increase PAP use and improve PAP adherence in persons without TBI. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel 4-session manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA. Study Aims: Study Aim 1 will test the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 will evaluate the feasibility of outcome and process measures. To date, no treatment exists to ameliorate the adverse consequences of moderate-to-severe TBI. OSA is a treatable health condition that commonly co-occurs with TBI, which is a leading cause of long-term disability. Method: In this study, 19 Veterans will be recruited from inpatient and outpatient TBI and sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe TBI; nonadherent to PAP, able to provide informed consent) will be invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention. Adherence will be measured via objective data from hospital software which monitors PAP use.

The O2VERLAP study investigators would like to find out if individuals living with both COPD and OSA would benefit from an online, educational curriculum, coupled with access to peer support (i.e. telephone and online chatting with peers) and remote CPAP adherence monitoring data. The curriculum and peer coaching is meant to provide participants the information and tools they need to be more compliant in using their CPAP device.

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 study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more difficult to control. As girls usually have a more severe asthma than boys, the investigators believe that girls have a higher risk of sleep apnea. To test if asthmatic girls have more sleep apnea than boys, the investigators are going to ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators are going test the lung function and how many times they stop breathing during the sleep. The sleep test is going to be performed in children's home. In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when they have an asthma attack. We also are going to look if sleep apnea increases the number of hospitalizations and asthma attacks in the past 12 months.

Obstructive Sleep Apnea (OSA) is the most common problem that affects sleep. People with this problem have their airway blocked or minimized, causing snoring or gasping while sleeping. It can also reduce the amount of oxygen that circulates in the blood of people affected by it. Millions of Americans have OSA; 10% of adults have diagnosed OSA, an estimated 25% have undiagnosed OSA. There is concern in the medical community about how to manage pain in patients with OSA because of the risk of decreased or slower breathing associated with certain pain medications called opioids. Giving OSA patients opioids could cause them to have even lower oxygen amounts in their blood stream. It is conceivable that patients with OSA may require lower doses of opioids to cause decreased breathing as compared to patients without OSA, however this has not been proven. In this study, we are using a very short acting and easily reversible opioid pain medication called remifentanil in patients with OSA in order to find out if treated and untreated OSA patients respond to opioid differently than patients without OSA.

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)

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.

Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS. SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality. The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.

To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.