Active clinical trials for "Sleep Apnea, Obstructive"

The main objective of this study is to investigate whether the non-surgical periodontal treatment of patients with periodontitis and obstructive sleep apnea syndrome (OSAS) affects the prognosis of OSAS positively with polysomnographic, serum and saliva parameters.

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with moderate to severe obstructive sleep apnea. Patients will be randomized to receive zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5 month open extension part will follow when patients in the tablet groups will all receive zonisamide. Patients in the open CPAP group will continue with CPAP treatment. Study hypothesis: Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is hypothesized that zonisamide has a direct pharmacological effect on respiratory control during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction of sleep disordered breathing.

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.

Hypertension affects an estimated 60-70 million Americans, predisposing them to potentially life threatening cardiovascular complications. Resistant hypertension, defined as uncontrolled blood pressure on 3 or more different antihypertensive agents, is common, affecting 15-20% of the entire hypertensive population or an estimated 12-14 million Americans. Although associated with obesity, increasing age, black race, and chronic kidney disease, mechanisms of treatment resistance remain obscure. The investigators' laboratory identified primary aldosteronism (PA) as a common cause of treatment resistance with a prevalence of 20% among subjects with resistant hypertension. This is clinically important because recognition of PA can lead to effective treatment with use of aldosterone blockers. Obstructive sleep apnea (OSA) is strongly associated with and predicts development of hypertension as demonstrated in landmark cohort studies including the Sleep Heart Health Study and the Wisconsin Sleep Cohort Study. The investigators' laboratory has confirmed OSA to be extremely common in subjects with resistant hypertension, with a prevalence of approximately 85%. Recognizing that PA and OSA are exceptionally common in subjects with resistant hypertension, the investigators hypothesized that the 2 may be causally related. In testing this hypothesis, the investigators recently reported that plasma aldosterone levels are positively correlated with OSA severity in subjects with resistant hypertension but not in normotensive control subjects. This observation suggests that there is an important mechanistic interaction between untreated OSA and aldosterone excess in subjects with resistant hypertension. While the investigators' original hypothesis was that OSA stimulates aldosterone release, the investigators recognize that the opposite may also be true; that is, aldosterone excess in subjects with resistant hypertension worsens OSA. Distinguishing between these two possibilities has potentially far-reaching clinical implications. If the former hypothesis is true, effective treatment of OSA would be expected to suppress aldosterone release in subjects with resistant hypertension, thereby reversing the underlying cause of their treatment resistance. If the latter hypothesis is true, use of mineralocorticoid receptor antagonists would be expected to reduce OSA severity in subjects with resistant hypertension, thereby enhancing treatment of OSA. Either scenario would represent a new treatment approach for a highly prevalent and serious medical problem.

Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.

Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor for perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie de Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year. Consequently, the identification and management of OSA in this high-risk surgical population is an essential part of practice. Actual guidelines recommend that treatment for OSA be initiated before the surgical procedure. Presently, the first line treatment for OSA is continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously to maintain the patency of the upper airways. However the compliance to this therapy is poor. An available alternative is automatic positive airway pressure (APAP) which delivers a variable amount of pressure to prevent reduction in airflow that accompanies upper airway obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse. APAP significantly reduces the mean level of pressure delivered in comparison to conventional treatment. Theoretically, it seems logical that applying the lowest pressure necessary would allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling obstructive events. APAP would be a valuable alternative if it was not for its excess cost. However, APAP improves compliance to treatment in two types of population: poor compliant subjects and those needing high pressure levels. The investigators know that compliance to positive pressure is poor in patients without excessive daytime sleepiness, which represents the majority of patient waiting bariatric surgery. Moreover, in patients needing levels of pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects and improves quality of life. The review of 180 files of OSA patients treated by CPAP who had bariatric surgery in our center in 2012 demonstrated that the majority of patients needed high level pressure. These values suggest that APAP could improve treatment compliance in apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and they generally require high positive pressure level.

Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness. Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.