Active clinical trials for "Sleep Apnea Syndromes"

The goal of this clinical trial is to test if ertugliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug). The main question it aims to answer is: If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants If improvement in clinical measures are because of improvement in the anatomic and physiologic traits. Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.

Obstructive sleep apnea (OSA) is a common, chronic and serious medical condition. Oral appliance therapy (OAT) also called mandibular advancement orthosis (MAO) provides long-term therapy for OSA patients. The Panthera D-SAD® is a computer aided design (CAD)/computer aided manufacturing (CAM), patient-matched, 3D printed, biocompatible nylon OAT. This five-year, observational prospective and multicenter study will assess the effectiveness of the PANTHERA D-SAD® orthosis on reducing the apnea hypopnea index (AHI) and obstructive sleep apnea-hypopnea syndrome (OSAHS) symptoms. Adherence, tolerance, and side effects will be evaluated. An estimated ten sites composed of a professional dyad, a specialist in sleep disorders, and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients. The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria, no prior use of OAT, and struggles or refuses continuous positive airway (CPAP) treatment. The professional collaborative nature of the study reflects real-world clinical practice. Participants will be followed over the course of five years at the following time points. Visits include the following: Specialist in sleep disorders: (1) Inclusion, (2) 3 months, (3) 2 years, (4) 5 years. Specialist in manducatory apparatus (dentist): (1) Inclusion, orthosis set-up and titration, (2) 6 months, (3) 2 and (4) 5 years The efficacy of the Panthera D-SAD® MAO will be assessed by the treatment success rate at five years, defined as a reduction ≥ 50% in the initial AHI, when monitored by nocturnal breathing polygraphy (NP) or polysomnography (PSG). Secondary endpoints will also be obtained at the aforementioned time points for reporting. The results of this study will fulfill regulatory requirements for reimbursement in France.

The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).

This is a prospective, observational study evaluating the relationship between severity of sleep apnea with severity of cognitive fog and if treatment of sleep apnea with CPAP improves cognitive fog in a cohort of post-COVID patients with sleep apnea.

Obstructive sleep apnea (OSA) is recurrent episodes of partial or complete obstruction of the upper airway during sleep that causes intermittent hypoxia and sleep fragmentation and leads to cardiometabolic and neurocognitive sequelae. Chronic intermittent hypoxia, sleep fragmentation of OSA, and insufficient sleep have been significantly associated with higher risks of neurocognitive impairment, including mild cognitive impairment (MCI) and Alzheimer's disease. Thus, sleep and circadian function might be modifiable neurocognitive impairment factors. The significance of the study is to understand the relationships of MCI with sleep apnea and sleep-related symptoms, which helps pave the groundwork for further research.

The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).

Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the resolution of OSA is better than the relationship between these biometric changes and BMI reduction.

Background Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way. Objectives The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice. Design A prospective, observational cohort study Study center General Hospital (AZ) Sint-Jan Brugge-Oostende Population The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015. Endpoints The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI). Duration In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data. Conclusions Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.

This study is aimed to evaluate whether the information provided by health care professionals in the visits previous to start with CPAP treatment may influence the number of reported adverse effects and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.

The primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy at three months after treatment initiation. The secondary objectives are to determine if earlier care improves the treatment effect of PAP on patient reported sleepiness, quality of life and patient satisfaction. We will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of PAP therapy, patient activation and self-efficacy with respect to OSA treatment. The study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of PAP adherence at three months.