Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Obstructive Sleep ApneaThe goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA). The main questions the study aims to answer are: Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG? What is the responder rate using the RXiBreeze PAP System? Participants will use the APAP function of the RXiBreeze PAP System while undergoing polysomnography (PSG) for two separate nights in a sleep center. During each visit, participants will also complete two patient reported outcome questionnaires: Epworth Sleepiness Score (ESS); and Functional Outcomes of Sleep Questionnaire (FOSQ) short form.
Comparison of Demographic Data Mentioned by the Patients or Measured by a Physician
Obstructive Sleep ApneaOSA (Obstructive Sleep Apnea) represents a major risk of postoperative complications. Predictive scores have been developed as the STOP-Bang score and the DES-OSA score. These scores take into account morphological parameters such as weight, height, and neck circumference. These data can be contained from the patients (self-reported) or by the measurements performed by a physician. The aim of this study is to compare the accuracy of both measurements (self-reported by the patient or measured by the physicians).
Prospective National Multi-center Registry of Obstructive Sleep Apnea Syndrome in Hypertensive Patients...
HypertensionObstructive Sleep ApneaStudy name: Screening, Diagnosis and Treatment of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China: A Prospective National Multi-center Registry. Rationale: Obstructive sleep apnoea syndrome (OSAS) is a common secondary cause of hypertension and significantly correlated with the risk of cardiovascular and cerebrovascular diseases. However, continuous positive airway pressure (CPAP) only shows modest blood pressure lowering effect, although it is effective in the relieve of daytime sleepiness and other symptoms of OSAS. One of the possible reasons for the low antihypertensive efficacy might be the low adherence to CPAP therapy. Nonetheless, few studies systematically investigated CPAP adherence with regard to its prediction and clinical relevance for cardiovascular protection and prevention. Objective: 1) To evaluate short- and long-term CPAP adherence in patients with hypertension and obstructive sleep apnea syndrome; 2) To investigate the predictors of short- and long-term CPAP adherence; 3) To explore the correlation between the CPAP adherence and blood pressure, target organ damage and the incidence of cardiovascular and cerebrovascular events. Study design: Prospective, multi-center, observational study. Study population: Patients with hypertension who are suspected to have obstructive sleep apnea syndrome due to snoring, daytime sleepiness and other related symptoms are considered eligible and should meet the following criterias: 1) Agree to participate in the study and sign the informed consent; 2) At least 18 years old; 3) STOP-Bang questionnaire, score ≥3 points; 4) Complete polysomnography in hospital; 5) Currently on CPAP therapy. Follow up: 3, 6 and 12 months after registry. Sample size estimation: At least 633 patients. Timeline: Start of subjects' enrollment: Jan 2023; End of subjects' enrollment: December 2026; End of study: December 2026. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases...
Obstructive Sleep ApneaThe ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH). ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. Obstructive sleep apnea (OSA) increase cardiovascular disease and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA. This study investigate the effect of CPAP on ROCK activity and left ventricle mass.
Evaluation of Self-efficacy as a Predictor for CPAP-compliance in a OSAS-patients French Cohort...
Sleep ApneaObstructiveContinuous positive airway pressure (CPAP) is the reference treatment for obstructive sleep apnea syndrome (OSAS) and is effective in improving symptoms of OSAS, reducing risk of accidents and improving quality of life. However, CPAP use is less than optimal. Recommended use is between 6-8 hour per night and a common clinical and empiric benchmark has been defined for CPAP use as an average of 4h per night for 70% of the night. Approximatively 30% of patients discontinue CPAP treatment during the first weeks. Thus, it is very important to identify the factors that influence CPAP adherence during the first weeks of treatment. Biomedical factors, in particular nose respiratory abnormalities, somnolence complaints and insomnia complaints, have been widely studied but explain only 4 to 25 % of the variance in CPAP use. Interestingly, "self-efficacy" (the confidence to engage in a treatment), was found to explain more than 30 % of the variance in CPAP use. The SEMSA (Self Efficacy in Sleep apnea) questionnaire is the instrument to investigate self-efficacy related to OSAS and CPAP that has received the most attention. Retrospective studies showed that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. Prospective studies showed that the factor "self-efficacy" of the SEMSA at baseline was associated with future CPAP use when it was completed after education information. A French version of the SEMSA has been validated by investigators in a retrospective study. They have confirmed in France that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. No prospective study using the SEMSA has been conducted in French patients with OSAS treated with CPAP. Given the specificity of the French health care system and home care system, it is thus important to evaluate the predictive value of self-efficacy on CPAP adherence in France. The generation of predictive model would enable pretreatment prediction of those likely to have difficulty with CPAP adherence, and would serve as the basis for the development of maximally effective interventions in order to enhance CPAP adherence by patients with OSAS.
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea...
Pediatric Obstructive Sleep ApneaBackground: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects. Researchers want to see how a monitoring device called near-infrared spectroscopy (NIRS) compares with the traditional techniques used in children s sleep studies. Objective: To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor. Eligibility: Children aged 3-12 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group). Design: Participants will be screened with a review of their medical records. If they have taken part in other NIH studies, that data will be reviewed as well. Participants in the NORM group will have 1 overnight study visit. Those in the OSA group will have 2 overnight study visits. Participants will do an overnight sleep study. They will have a physical exam and medical history. They will have a sleep study electroencephalography (EEG). For this, electrodes will be placed on their head. They will wear a gauze cap to keep the electrodes in place. Two NIRS probes made of a soft silicon will be placed on their forehead and arm. They will follow their normal bedtime routine. Their parent will stay overnight. The OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea. They will repeat the sleep study.
An 18-year Follow-up Study on OSA in a Population-based Cohort
EpidemiologyNatural History3 moreOur research team has established a polysomnography (PSG) quantified population-based paediatric sleep cohort in 2003 for a childhood OSA prevalence study. Subjects were recruited from 13 randomly selected primary schools. All subjects from this original cohort will be invited to join this 18-year follow-up study to repeat the following data collection: questionnaires, anthropometric measurement, sleep study, 24-hour ambulatory blood pressure (ABP) measurement, echocardiography and neurocognitive assessment.
Prevalence of Sleep Apnoea in Adolescents
Obstructive Sleep ApneaObstructive sleep apnoea (OSA) is associated with a variety of important complications, namely cardiovascular, neurocognitive and metabolic disturbances. The prevalence of OSA is well studied in children and adults. However, adolescence - an interface between childhood and adulthood, and a period of developmental changes known to affect sleep is largely unexplored in relation to OSA. The only published prevalence study on adolescents is limited by its small sample size, not a true representation of the general population and primarily focused on Caucasians. In this proposal, the investigators aim to determine the prevalence of OSA, and associated clinical features in a population-based sample of adolescents aged between 12 and 16 years. The sample selection will be based on a stratified (by districts) and clustered (subjects within randomly selected schools) randomised sampling frame. Each participant will fill in a sleep habit questionnaire, undergo anthropometric measurements, physical examination and complete home polysomnographic recordings. Participants will undergo Conners' Continuous Performance Test and have blood samples taken to phenotype their cardiovascular and metabolic risk. The primary outcome is prevalence of OSA, assessed by the obstructive apnoea hypopnoea index. Secondary outcomes include use of logistic regression models to assess association between different severities of OSA and various demographic, clinical and laboratory variables. The obtained result will provide the much-needed OSA prevalence in adolescents which is essential for estimating the true burden of disease within this population. This information is also vital when considering population-based health policies and interventional strategies. Globally, the findings from currently evidence-sparse region of the world allow future international comparison of disease burden. Our study will also form a platform from which repeated measurements can be made to assess time trends and to answer the important question of whether adulthood OSA takes its origin from adolescence.
Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE)
Obstructive Sleep ApneaRespiratory FailureHealth care renunciation is a factor that can alter patients' health status and increase the costs of its support. To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes. The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance. The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ). The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.
Extracellular microRNA: Biomarkers of Endothelial Dysfunction in Obese Adolescents & Adults With...
Obstructive Sleep ApneaUsing a prospective observational approach and a clinical trial design comparing the effectiveness of continuous positive airway pressure to diet and exercise, investigators plan to evaluate how obstructive sleep apnea (OSA) leads to endothelial dysfunction in adolescents and young adults and whether treatment of OSA can improve endothelial dysfunction. Concurrently, investigators will measure miR 92a/miR 210 levels in all subjects at baseline and following therapy to determine whether miR 92a/miR 210 levels reliably predict endothelial dysfunction in patients and responses to therapy.