Active clinical trials for "Apnea"

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.

Obstructive sleep apnea (OSA) is a multi-factorial sleep disorder. Complete collapse or partial collapse in the airway increases the risk of developing cardiovascular and kidney-related disease in OSA patients. Resulting in an increase in medical expenses and workload for the healthcare worker. Multilevel of upper airway muscles especially the genioglossus muscle showed to contribute to airway obstruction as it fatigues easily. The endurance level of OSA patients was shown to be significantly lower. Therefore, the goal of this experimental study is to assess the feasibility and effectiveness of a comprehensive respiratory training exercise program on cardiorespiratory endurance, airway muscle function, and sleep parameters in patients with obstructive sleep apnea (OSA). Aside from exploring the therapeutic effect, the results of the study will be used to explore the mechanism of the treatment in relation to the changes in the OSA severity.

The role of obstructive sleep apnea (OSA) on chronic kidney disease (CKD) is not clear. This randomized clinical trial will test the impact of OSA treatment on blood pressure (BP) and on the estimated glomerular filtration rate (eGFR) in patients with CKD IIIb and IV (eGFR 44-15 ml/min). A polygraph will be performed to assess the presence of OSA (defined by an apnea-hypopnea index ≥15 events/hour). Patients with OSA will be randomized to use continuous positive upper airway pressure (CPAP) or to maintain optimized clinical treatment for BP control. Antihypertensive medication adjustments will be allowed using a standard protocol for both groups by the same researcher, who will not have access to CPAP follow-up. In addition to clinical (including BP and ambulatory BP monitoring, ABPM) and laboratory assessments at baseline, we will follow up at 3 months, 6 months, 9 months and 12 months after randomization of the proposed outcomes. Target organ damage analyses, such as the retina and echocardiography, will be performed at baseline and after 1 year of randomization. Primary objective: to compare the effect of CPAP on the need to adjust antihypertensive medication to control systolic BP (<130mmHg) in patients with CKD; secondary objectives: 1) to evaluate the reduction in systolic and diastolic BP by office and ABPM; 2) assessment of nocturnal BP dipping; 3) to evaluate the impact of OSA treatment with CPAP on eGFR during follow-up; 4) to evaluate the impact of OSA treatment with CPAP on the evolution of albuminuria; 5) assessment of other target organ damage such as retinopathy and cardiac remodeling; 6) to evaluate the impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR <15ml/min and dialysis); 7) to evaluate the impact of OSA treatment with CPAP on the quality of life of patients with CKD. With a significance level of 5% and study power of 90%, two-tailed hypothesis testing, 74 patients with OSA per group, i.e., 148 patients in total, will be required to assess the primary endpoint (we estimate that 25% and 50% of patients in control and CPAP groups will not need to adjust their antihypertensive medication at follow-up, respectively).

The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.

Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement Appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient's acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care. The investigators also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index >5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA. Patients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and/or prevents their adherence.

ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them. METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center. During the study period: Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1). Assessment of PAS/PAV stability (relapse) at short term (1 month). 3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery. Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist) Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12). Record of body mass index (BMI) (cm/Kg2) Main Objective: • Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA. Specific objectives: • Interrelate the degree of dentofacial deformity with the IAH. Study the potential correlation between the volume of the VAS and the IAH. Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS). Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA. Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA. To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA. Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA. Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term. Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery. Hypothesis H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term. H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.

Study design (e.g., double-blind: A randomized, open-labeled, controlled, parallel-group study. Sixty patients will be recruited with moderate to severe Obstructive Sleep Apnea (OSA), previously adherent to CPAP therapy and have controlled OSA defined as Apnea Hypopnea Index (AHI) of < 5 while on treatment. Patients will be divided into two groups after completion of Therapeutic CPAP, Who will continue on same CPAP therapy for 4 weeks they will be randomized into two groups: NO CPAP (NOCPAP Group): Who will stop using the CPAP device. Intermittent CPAP (Int-CPAP Group): Who will use the CPAP device every other night. This trial will also evaluate the effects of CPAP withdrawal (complete or partial) on excessive day time sleepiness (EDS), apnea hypopnea index (AHI), Heart Rate and Blood Pressure.

Continuous positive airway pressure (CPAP) has a caricatural effect in reducing nocturnal respiratory abnormalities and improving the micro-and macrostructure of sleep. Studies characterizing the improvement of acute sleep parameters after the initiation of CPAP are limited to one or two nights of polysomnographic recording. This is related to the cost of performing these studies with repeated recordings in the laboratory and to the acceptability by patients to perform multiple nights of recordings. Investigators currently have powerful and reliable methods allowing us to carry out nights at home in the patient's ecosystem, in real-life conditions. The characterization of sleep parameters by these methods is equivalent to a polysomnographic recording. These technological innovations will allow us to characterize sleep before the initiation of CPAP treatment during several nights performed at home. Investigators will then be able to characterize the kinetics and stability of the improvement of sleep parameters in patients with obstructive sleep apnea syndrome in whom continuous positive airway pressure is initiated. These data will be original and will serve as exploratory data to judge whether the objective improvement of sleep parameters in the first weeks of treatment is associated with improvement in sleepiness, quality of life, and compliance with treatment.

This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.