View clinical trials related to Sleep Apnea, Obstructive.
Filter by:Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.
Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA). Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events [>80%)]. Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment. Intervention: Patients will be randomized (1:1) to control group [treatment and follow-up according to conventional clinical practice] or intervention group [in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and > 10000 steps/day: maintain or increase steps). Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.
The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the general population, causing an increase in sympathetic activity, changes in systemic blood pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms that are altered as a result of the events associated with obstructive sleep apnea (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are epidemiological studies. The alterations in the expression profile of endothelial and cardiovascular dysfunction biomarkers and sex hormones disorders that are altered as a result of the events associated with OSA are associated to erectile dysfunction development. Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and patients with erectile dysfunction may improve erectile function. The primary objective of the study is: 1. To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients. The secondary objectives are: 1. To determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder, which are altered as a result of the syndrome of obstructive sleep apnea and its relation to the risk of developing erectile dysfunction. 2. To compare the secretion profile of sex hormones related to control erectile function in a group of patients with syndrome of obstructive sleep apnea with and without erectile dysfunction. 3. To assess the prevalence of erectile dysfunction in patients with OSA. 4. To compare the psychological profile of patients with OSA with and without erectile dysfunction in order to detect psychological distress associated with the risk of developing erectile dysfunction. 5. To evaluate the impact of CPAP treatment on the secretion profile of sex hormones related to control erectile function in OSA patients. 6. To evaluate the impact of CPAP treatment on the psychological profile of patients with erectile disfunction in OSA patients.
The investigators hypothesize that partial robotic tongue base resection surgery and / or soft palate surgery, as a treatment for sleep apnea affect the swallowing quality.In order to characterize the dysphagia The investigators will locate participants undergoing this surgery more than six months ago.The investigators will test their swallowing by fiberoptic endoscopic evaluation of swallowing (FEES) and let participants fill out a questionnaire regarding swallowing disorders swallowing dysfunction questionnaire (SDQ). Also the investigators will use data collected from participants who have undergone this surgery and already had these tests due to swallowing complaints.
To understand if a progressive increase in end-tidal carbon dioxide (CO2) levels are heralding respiratory difficulties before desaturation measured from capnography in obstructive sleep apnea patients, with the use of nasal prongs, transcutaneous monitors, Capnostream, and Massimo technologies.
Obstructive sleep apnea is often associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between obstructive sleep apnea severity, age, gender and heart rate response associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington. Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial. This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.
Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper airway obstruction during sleep. Patients are associated with sleep disorders, frequent desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA prevalence increased in China in recent years. It is estimated that nearly 80% of men and 93% of women are not diagnosed for moderate and severe OSA. Anesthesiologists and surgeons paid more attention on those high risk patients. The gold standard for OSA diagnosis is apnea and hypopnea index (AHI) obtained from polysomnography (PSG). But it is difficult to carry out PSG regularly in primary health care institutions in China for its high cost and long waiting list. So many OSA questionnaires are developed in Europe and North America, obesity is an important risk factor for OSA for them. But in China people have different anatomical characteristics, the diagnosis sensitivity and specificity of those methods has not been reported in China. Methods and Design: Participants for this study will be recruited in Beijing Tongren Hospital scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in sleep center. 2. To receive OSA correction surgery (UPPP). 3. To receive ophthalmological surgery under general anesthesia. Detailed inquiry and record all medical history. Upper airway assessment will be recorded. Preoperative snoring questionnaires will be integrated according to the four questionnaires. All patients complete PSG monitor. For patients undergoing surgical treatment, postoperative continuous pulse oximetry will be recorded for 24 hours. All postoperative adverse events will be recorded. The primary endpoint: All the patients complete the four snoring questionnaires (ASA, Berlin, STOP and STOP-BANG) before PSG test. The secondary endpoints: PSG monitor will be completed before operation. Medical history, upper airway assessment, postoperative 24 hours continuous pulse oximetry monitor and all perioperative adverse events will be recorded. The purpose is to compare the specificity and sensitivity of four questionnaires to figure out OSA. To find suspected OSA patients before operation with one easy-to-use assessment questionnaire and direct OSA clinical practice.
We intend to study, in depth, the quantitative and qualitative properties of nasal respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP) treatment with the final goal of improving patient outcome. To do this we will temporarily alter patients' nasal airflow during monitored sleep to lower CPAP air pressure, making CPAP treatment more acceptable to the patient. Additionally we plan to implement highly advanced computerized modelling in collaboration with the OSASMOD research consortium at St. Olavs Hospital/NTNU and SINTEF to predict the results of our alterations and ultimately, to use these predictions to improve both the planning and the outcomes of nasal surgery.
The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of OSA patients and to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters. Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group. Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between groups.