Active clinical trials for "Sleep Apnea Syndromes"

Primary objectives: The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale; Secondary Objective: the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques

Supine positioning was reported to increase upper airway collapsibility, apnea frequency and duration. Positional therapy, designed to minimize supine sleep, was reported to be beneficial in the general sleep apnea population. As supine sleep is very common in stroke patients, positional therapy might also have therapeutic effects. Given differences between stroke patients with sleep apnea and the general sleep apnea patient, such as rolling ability, body mass index and daytime sleepiness, positional therapy results in the general population may not be applicable to the stroke patient. The effects of positional therapy in ischemic stroke patients with OSA have not been well-investigated. We therefore performed a pilot randomized, controlled, cross-over study to test the following hypotheses: (1) positional therapy reduces the amount of nocturnal supine positioning in patients with subacute ischemic stroke, and (2) severity of sleep apnea improves, as reflected by apnea-hypopnea index (AHI), during positional therapy. The tolerability of positional therapy over a 3-month period in patients with ischemic stroke was also evaluated.

The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder in which there are problems with breathing during sleep) in World Trade Center Responders. The study will look at the relationship between sleep apnea and various nose and throat conditions. Specifically, the study will look at upper airway disease (problems with the nose and throat), nasal inflammation, and nasal resistance (the amount of airflow through the nose). Subjects will have a physical exam and answer questions about nasal symptoms and sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry (measuring the airflow through the nose) will also be performed to measure the degree of airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring. Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep apnea is treated by using a CPAP (continuous positive airway pressure) device. This device blows air into a mask worn by the patient during sleep. The two treatment methods that will be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex (pressure decreases when the subject exhales). Patients will be randomly assigned to one treatment method for one month then crossed to the other treatment method for the next month. The investigators will determine if patients with certain nasal conditions (high nasal resistance) are more likely to use CPAP-flex rather than CPAP.

OSA is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions (such as OSA) live healthier and more productive lives through better management of their conditions. Using an mHealth tool to help deliver the investigators' Self-Management intervention and improve the frequency and quality of patient-provider communications is a central component of that discovery process.

SUMMARY Rationale: Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are position dependent, defined as having an AHI, which is at least twice as high in supine sleeping position compared to the AHI during sleep in other positions. Standard therapy for patients having mild or moderate POSA is treatment with an Oral Appliance Trainer (OAT). Recently a new device Sleep Position Trainer (SPT) is been introduced especially for patients with POSA. Objective: To compare the effect of positional therapy with the SPT versus OAT on polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for positional therapy over a long term. Study design: Randomised controlled trial Study population: The participants of the research will be recruited from the departments of Otolaryngology and Clinical Neurophysiology, Saint Lucas Andreas Hospital, Amsterdam, the Netherlands. Participants will be males or females older than 18 years with diagnosis of positional OSA. Intervention: The SPT is a sensor positioned in an elastic band attached around the body. The SPT measures the body position and vibrates when the patient lies in supine position. Oral appliance therapy (OAT) is an intra-oral prosthesis, which holds the mandible in a protrusive position. Because of this position more pharyngeal space will be available and the AHI will decrease. After randomisation the first group (n=45) will sleep for a period of 90 +/- 2 days with the SPT every night. The second group (n=45) will also sleep for a period of 90 +/- 2 days only with OAT. After this period the PSG is repeated. Long- term outcome in AHI is measured by repeating the PSG after 1 year. Main study parameters/ endpoints: Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine sleep position, without disturbance of the sleep quality. Secondary endpoints: Outcome of Quality of Life questionnaires; EQ-5D, ESS, FOSQ and MFIQ. Compliance and learning effect will also be evaluated for the time period of 3 and 12 months. Finally cardiovascular parameters like blood pressure, pulse rate and BMI/neck circumference will be assessed. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for patients participating in this study are negligible. Inconveniences of the SPT can be discomfort caused by irritation of the band, difficulties with an increased sleeping period on the side or difficulties sleeping with the SPT. This can be compensated by the expected improvement of sleep quality caused by the therapy. Possible side effects of OAT may be discomfort in the jaw, sensitivity of the teeth and a dry mouth. Withdrawing from this therapy means immediate relief of inconveniences.

The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.

The purpose of this study is to compare the cost-effectiveness and effectiveness of mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP) therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).

Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict oral appliance response

Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important. The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.

The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation: A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls. A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.