View clinical trials related to Sleep Apnea, Obstructive.
Filter by:The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
TheraPAP is a novel therapy approach being developed by SleepRes, LLC. for the treatment of obstructive sleep apnea (OSA). This algorithm has been integrated into the Sefam S.Box CPAP (continuous positive airway pressure) device and both standard CPAP/APAP (auto-titrated PAP) as well as TheraPAP can be delivered. TheraPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until some point in late expiration. In this randomized crossover study, the comparative adherence to therapy between TheraPAP and APAP will be compared. Each therapy will be used by the patient for six-week periods with randomly assigned order, and the usage during each arm will be compared.
The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA. Pre-screening is conducted to establish potential eligibility based on regular usage of > 4 hours/night on patients who use an APAP device with a PRA mode. Participants would then be recruited as described below. For those who sign an informed consent, they will be instructed to use the device for the next 8 days with the PRA turned on for four consecutive nights and off for four consecutive nights, but in random orientation. To make sure that the device is not limited to APAP range when adjusting to respond to PRA, the upper limit will be changed to 20 cmH2O during the study. Additionally, only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the maximum PRA setting of 3 cmH2O can be used.
The prevalence of sleep-disordered breathing is high, with an apnea-hypopnea index of over 15 per hour found in 49.7% of men and 23.4% of women in the general population (1). The gold standard treatment for sleep-disordered breathing is continuous positive airway pressure (CPAP) therapy (2). However, nearly 30% of patients are considered non-adherent to CPAP treatment (3). Moreover, the number of hours of CPAP usage has been shown to be directly associated with a reduction in objective and subjective sleepiness, and improvement in daytime functioning (4). A recent prospective study conducted in a French clinical population cohort of 5138 participants found an effect of CPAP treatment duration on reducing the risk of developing a major cardiovascular event (stroke, myocardial infarction, all-cause mortality) (5). Therefore, the poor adherence to CPAP treatment represents a public health challenge for healthcare professionals managing these patients. Several predictors for non-adherence can be identified, such as using CPAP for less than 4 hours per night during the initial treatment phase, moderate to severe obstructive sleep apnea, or low self-esteem (6). Measures aimed at promoting patient adaptation from the initiation of treatment are crucial as this period determines long-term adherence to CPAP therapy (7). Among these measures, there is the management of "physical" adverse effects such as xerostomia (using a humidifier), feeling too much or too little air (modifying CPAP pressure profiles), skin problems, and mask air leaks (interface adjustment), which are well-known and applied by health care organization providing the CPAP machines (2). On top of these "technical" problems, patients related issues such as mask-induced anxiety, psychosocial conditions, and dysfunctional thoughts about CPAP treatment may prevent patients from using their CPAP properly. Innovative tools such as psycho corporal therapies, including medical hypnosis, could be used in these situations. A recent literature review focusing on the impact of medical hypnosis on sleep disorders in adult patients found an improvement in various sleep parameters (sleep quality, insomnia complaints, frequency and/or intensity of parasomnias) in 58.4% of patients. However, in this systematic review of 24 studies, none of them explored the use of medical hypnosis in sleep-related breathing disorders (8). Hypnosis can be defined as an altered state of consciousness in which a person's attention is detached from their immediate environment and absorbed in inner experiences such as feelings, cognition, and imagery (9). Hypnotic induction involves focusing attention and imaginative involvement to the point where what is imagined seems real. By using and accepting suggestions, the clinician and the patient create a benevolent hypnotic reality with the goal of improving the patient's clinical situation (10). In the literature, there is only one clinical case report describing a benefit of medical hypnosis for CPAP tolerance in a child with cherubism (a rare fibro-osseous genetic disease-causing nasal obstruction). In this case, CPAP therapy using an oral interface was fully accepted after three hypnosis sessions and corrected the obstructive sleep breathing disorder (11). In a slightly different domain, there is a case report of successful use of medical hypnosis as an adjunct therapy for weaning from mechanical ventilation (12). Our hypothesis is that the use of medical hypnosis in CPAP-treated patients could improve the patient's perception of the treatment, making it more positive. Medical hypnosis could occur very early in the management process, with rapid learning of self-hypnosis to actively influence this crucial period for long term adherence of CPAP. The principal objective is therefore to evaluate the effects of medical hypnosis on adherence to CPAP therapy in patients with sleep-disordered breathing.
This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.
This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with IgA nephropathy (IgAN), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and IgAN.
This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with chronic kidney disease (CKD), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and CKD.
This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) resulting from chronic tonsillitis on pregnancy outcomes. The hypothesis posits that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.
This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. The hypothesis posits that OSA may aggravate pregnancy complications, elevate the risk of adverse pregnancy outcomes, and potentially impact fetal development.
We will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with COPD and OSA. We will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. We will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. < 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, we will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. Our primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, we will also conduct a concurrent implementation process evaluation using the RE-AIM framework.