Active clinical trials for "Sleep Apnea Syndromes"

The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).

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 mandibular advancing devices-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 MAD response.

to test whether using CPAP can restore the normal pattern of drop of blood pressure during sleep.

Every year thousands of young children with obstructive sleep apnea undergo surgery which requires them to be prescribed pain medication. The current standard in North America is administration of opioids, mainly codeine or morphine; however in many areas of the world including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some North American surgeons are uncertain regarding the potential of ibuprofen to increase bleeding following surgery. The results of research studies have been inconclusive overall. Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been removed from the formulary at many Pediatric institutions. Some surgeons have begun to use oral morphine as an alternate to codeine, which necessitates the need to find safe alternative analgesics in this treatment group. The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine and ibuprofen in children with sleep apnea. An interim analysis will be conducted after recruitment of 70 patients, to monitor both safety and efficacy

The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP). An interim analysis will be performed when 40 patients will be included.

Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure. Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.

Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.

The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.

AIMS:To know the effects of the treatment with nasal positive continuous airway pressure (CPAP) on systemic blood pressure and the expression of biological mediators, in systemic hypertension of recent diagnostic, whose have an apnea-hypopnea index > 15. METHODOLOGY: DESIGN: Prospective, multicenter, randomized study, of parallel groups and controlled with placebo, in patients diagnosed of systemic hypertension (SH) with an apnea-hypopnea index, by conventional polysomnography > 15. A total of 340 patients with recently diagnosed of SH and without any pharmacological treatment will be studied. All patients will be randomized to receive, alternatively, CPAP treatment with optimal pressure titled with a proved system, or Sham-CPAP for 12 weeks. MEASUREMENTS: A) Conventional polysomnography at baseline: B) Clinic: sleepiness (ATS, Basic Nordic Sleep Questionnaire and Epworth), quality of life (EuroQol); C) 24 hour blood pressure monitoring; D) Expression of biological mediators in blood: general determinations, endothelial, inflammatory, lipid, renin-angiotensin-aldosterone and adrenergic mediators. ANALYSIS. Baseline measurements of all the variables will be compared with the situation at six and twelve weeks. We will use the chi square test and the Fisher´s exact test (categorical variables), the t test for continous variables and repeated measures ANCOVA for the primary objective. The analyses will be done under the criterion of intention to treat and for protocol. The variables will be controlled by the compliance with the CPAP..

Acetazolamide improves central sleep apnea related to opium consumption.