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.

Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder, and is characterised by repetitive complete or partial upper airway obstruction during sleep. It is an important disease as it is associated with a large spectrum of end-organ morbidities. Adenotonsillar hypertrophy is the commonest cause of OSA in children, however, the cause of the lymphoid tissue hypertrophy in some individuals but not the others remains unknown. To address the cellular heterogeneity and immune cell involvement in adenotonsillar hypertrophy, here, we propose to employ single-cell sequencing analysis to identify the cell-specific expression patterns associated with the disease, which will enhance our understanding of the pathogenesis of tonsillar hypertrophy in children with OSA and may provide directions for development of novel therapy.

The main aim of the study is to check the side effects from overnight treatment with danavorexton and assess the tolerability of varying doses of danavorexton administered intravenously. Before starting treatment with danavorexton, participants will keep a sleep diary and use an under-mattress sensor for at least 7 nights to check regular sleep habits. There will be 3 Treatment Period up to 14 days apart. In each Treatment Period, participants will receive an intravenous (through the vein) infusion of either danavorexton or a placebo starting in the evening and continuing over a 10-hour period. A placebo looks exactly like danavorexton but does not have any medicine in it. Participants will take part in a follow-up phone appointment about a week after the last Treatment Period.

Study Objectives: Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in stroke patients, with adherence rates for CPAP therapy of only 30%. The primary objective of this study is to determine whether CPAP adherence in stroke patients with obstructive sleep apnea can be improved by a CPAP training strategy during rehabilitation combined with a telemedicine monitoring system after discharge. The secondary objective is to compare recording quality as well as subjective and objective sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in the management of sleep apnea in stroke. Further the investigators aim to study changes in nocturnal systolic blood pressure due to CPAP therapy with the pulse transit time method. Finally, the investigators intend to study the relationship between CPAP compliance, sleep and medical and neurorehabilition outcome parameters. Design: Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to severe OSA. Setting: Neurorehabilitation center in Vienna, Austria Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal AHI< 10) at the neurorehabilitation unit. Interventions: Patients will be randomized to either standard care with an autotitrating CPAP device or an autotitrating CPAP device that transmits physiologic information (i.e., adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare provider. If any problems are identified, the patient will be contacted by his homecare provider by telephone. Neurologists performing sleep and neurological scoring will be blinded to the randomization. Measurements: Recording of the different measuring systems, subjective and objective sleep quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP determined by means of a non-linear algorithm and an individual one-point calibration of the pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany) and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.

The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.

The goal of this study is to understand the contribution of sleep-disordered breathing (SDB) to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression. The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on sleep and depression symptoms in perinatal women. Participants will be pregnant women with depression and sleep-disordered breathing. Participants will be randomly assigned to receive either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at baseline and again 8 weeks later.

Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent episodes of partial or complete collapse of the upper airway during sleep, leading to pauses of breathing and arousals. Although previously considered as a local abnormality of the respiratory track, it is nowadays recognized as a systemic disease and an important cause of morbidity and mortality, since it is strongly associated with obesity (especially abdominal obesity) and cardiometabolic diseases, including cardiovascular diseases and diabetes mellitus. Interestingly, recent hypotheses support that the metabolic syndrome pathology, including insulin resistance, inflammation and oxidative stress may be involved in OSA pathogenesis. The modification of lifestyle habits, e.g. in terms of diet and physical activity, is currently explored as a mean of managing the disease in combination with the first line treatment, i.e., the application of continuous positive airway pressure (CPAP) during sleep. The available data support that weight loss, achieved through lifestyle modification, effectively reduces the severity of OSA and improves the associated cardiometabolic disorders in overweight or obese patients. However, studies exploring the potential effect of diet's quality or other lifestyle habits (such as physical activity) on OSA severity, besides weight loss, are currently lacking. Given that a Mediterranean dietary pattern, as well as other lifestyle habits adopted by the populations in the Mediterranean region, have been proven beneficial both for the prevention and the resolution of the metabolic syndrome and its associated cardiometabolic diseases, the aim of the present randomized, controlled, single-blind study is to implement an intensive intervention based on the Mediterranean lifestyle (hypocaloric diet and 7 group lifestyle counselling sessions) and to evaluate its potential benefits, compared with standard care (hypocaloric diet and written advice for healthy lifestyle), in a sample of patients with OSA.

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).

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.