Active clinical trials for "Sleep Apnea Syndromes"

The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.

Hypertension is a frequent condition affecting 11M Spanish citizens and is the leading modifiable contributor to cardiovascular disease and death. Our society has already identified balanced diet, physical activity and emotional wellbeing as the 3 pillars of healthy living. Healthy sleep should be incorporated as the fourth pillar, as clearly supported by the extensively available scientific evidence. Targeting sleep is considered the new frontier in cardiovascular prevention. In fact, recent scientific evidence encourages consideration of including sleep disturbances in the top 10 potentially modifiable cardiovascular risk factors. Sleep-disordered breathing affect 30-80% of patients with hypertension. The personalized management of hypertension is challenging due to; i) the misclassification of hypertensive patients (affecting 1 out of 3 patients); ii) the lack of adequate treatment of high mortality risk hypertensive phenotypes today is an unmet clinical need; iii) unawareness of the impact of sleep-disordered breathing as a modifiable risk factor for hypertension. Importantly, we already made the seminal observations showing that the treatment for sleep-disordered breathing reduces blood pressure in the hypertensive phenotypes with the highest mortality risk. Given the need for novel strategies to treat hypertension and, supported by our data, we propose to study and treat sleep-disordered breathing to improve hypertension control. METASLEEP will go beyond current state-of the-art providing a new paradigm for the accurate hypertension classification and treatment. This project will open up a new avenue on the therapeutic potential of the management of sleep-disordered breathing in hypertension.

To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy. Hypothesis 1. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of: Apnea Hypopnea Index (AHI) reduction Amount of side effects Amount of Leaks Hours of use (compliance) CPAP pressure 2. There is a difference between connected and disconnected for the following symptoms: Epworth sleepiness Scale (ESS) Functional Outcomes of Sleep Questionnaire (FOSQ) Side effects Study Design - randomized prospective parallel

The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. The intended purpose of the investigational device is to deliver a transcutaneous electrical stimulation signal to the hypoglossal nerve in the "ON" phase in order to alter the apnea hypopnea index (AHI), as well as mean snoring burden (intensity, duration), and to deliver no signal in the "OFF" phase of the study as a means for comparison. Subjects utilizing the ZENS Device will experience a reduction in snoring during the "ON" versus "OFF" phase, as quantified by a reduction in the percentage of time per hour of snoring (≥40 dB) in the active ZENS Device ("ON" phase) versus the inactive ZENS Device ("OFF" phase).

To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.

The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents. This study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).

The purpose of this study is to evaluate the effects of moderate energy restriction on the body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress, inflammatory biomarkers, metabolic profile and endothelial function in obese patients with OSA.

The purpose of this study is to investigate the impact of exposure to ergonomic circadian light on physiological and mental parameters in stroke patients admitted for rehabilitation.

Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious medical condition with significant medical and psychological consequences, including diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway creating a "pneumatic splint" to keep the airway open during sleep. Adherence to PAP is notoriously low, with as few as 50% reaching minimal guidelines for adherence. One comprehensive review of adherence research found that adherence to PAP was less than that for any other medical disorder. The problem of adherence is significant not only because of the medical consequences that can ensue, but also because third party payers have begun to refuse to pay for PAP therapy when adherence is less than optimal, even in the face of clinical improvement. This is a critical time to address this problem. This research study is designed to identify methods that may help people respond to PAP, the most common therapy for OSA. Identifying these methods may be an important way to better care for patients with obstructive sleep apnea. With this research, the investigators hope to find ways to help people have a better response to treatment and a better quality of life.

This is a short term open, randomized cross over trial to explore and compare the efficacy of pharmacological carbonic anhydrase (CA) inhibition on obstructive sleep apnea (OSA) related hypertension. Patients will be randomized to receive Acetazolamide(Diamox®)(ACZ), Continuous Positive Airway Pressure (CPAP)or CPAP plus ACZ for 2 weeks. Following a 2 week wash-out period all study participants will receive the alternative treatment regimen. The total length of the study will be 10 weeks. The effects of carbonic anhydrase inhibition on blood pressure,hemodynamics and sleep apnea will be investigated. Study hypothesis: Carbonic anhydrase inhibition alone or in combination with nCPAP will prominently reduce blood pressure in patients with OSA. Further it is hypothesized that CA inhibition will induce a direct pharmacological effects on vascular stiffness as evidenced in overnight non-invasive assessments of vascular stiffness and that this effect will be particularly strong in patients also responding with a reduction of blood pressure.