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Sleep Apnea Syndromes clinical trials

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NCT ID: NCT06467682 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

12-week Tele-exercise Program in Patients With OSA

Start date: September 2024
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) contributes to a number of adverse health effects, particularly on brain health. Chronic sleep disturbances caused by OSA could adversely affect cognitive health. Exercise is recommended as a non-pharmacological intervention for patients who are intolerant to continuous positive airway pressure (CPAP) and has been shown to have beneficial effects on brain health and cognitive function. The aim of this protocol is to investigate the effects of a 12-week tele-exercise program on cognitive function and specific parameters of brain activity, including brain metabolism and oxygenation, in patients with OSA. The project aims to demonstrate the multi-dimensional relationship between exercise, cognition and brain oxygenation/metabolism. Our local ethics committee has approved the study. Our population sample (group A = OSA with cognitive impairment (CI) and tele-exercise; group B = OSA with CI and no tele-exercise; group C = OSA without CI and no tele-exercise) will undergo assessment both before and after a 12-week tele-exercise intervention program. This assessment will include a comprehensive battery of subjective and objective assessment tests. Data will be analysed according to group stratification. We hypothesize a beneficial effect of tele-exercise on sleep and cognitive parameters and we are confident that this study will raise awareness among healthcare professionals of the brain health benefits of exercise in patients with low compliance to CPAP treatment.

NCT ID: NCT06465134 Recruiting - Hypertension Clinical Trials

Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

AF-MiTriSto
Start date: November 1, 2023
Phase:
Study type: Observational

Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA. In this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated. 300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.

NCT ID: NCT06464757 Recruiting - Quality of Life Clinical Trials

Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year

Start date: January 1, 2024
Phase:
Study type: Observational

Laryngomalacia is the most frequent cause of stridor in children under 1 year. The airway obstruction generates turbulent airway flow and creates the characteristic high-frequency stridor sound. In addition, the airway obstruction can cause apnea, a following drop in oxygen saturation and sleep disturbances. The symptoms of laryngomalacia are often worsened by activity, feeding, crying and lying flat on the back. The diagnosis is made with flexible laryngoscopy when the child is awake. The children are most often treated with expectation, information and guidance, observation with help with feeding and reflux treatment. Up to 20% of patients have a severe degree of laryngomalacia with apneas, which is an indication for surgical treatment. The investigators want to examine whether sleep examinations can help us deciding which child benefit from surgery, and follow-up the child again after 4-6 weeks and 1 year. The sleep examinations are carried out with polygraphy and/or polysomnography with simultaneous audio records and video monitoring and with Somnofy from VitalThings. The investigators want to use artificial intelligence and machine learning when analyzing the sleep examinations. The investigators also want to have a control group examining the sleep and breathing during night at home. In both groups the investigators want to examine the quality of life with the questionnaire ITQoL-SF47.

NCT ID: NCT06463561 Not yet recruiting - Dyslipidemias Clinical Trials

CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea

CPAPLIP
Start date: June 20, 2024
Phase: Phase 4
Study type: Interventional

Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia. Objectives: Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA. Secondary objectives: - To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA. - To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA. - To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA. - To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA. - To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA. - To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA. - To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones. - To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid. Design Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment. Study population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications. Sample size: 110 patients in each treatment arm. Treatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms: 1. Conventional hygienic-dietary recommendations and promotion of daily physical activity. 2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP). Efficiency variables - Main variables: LDL-cholesterol and uric acid. - Total cholesterol, HDL-cholesterol and triglycerides. - Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein. - Systemic biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A/hypocretin 1 and ghrelin). - Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ. Safety variables - Clinical adverse event reporting. - CPAP compliance (average hours of use per day). - Epworth Sleepiness Questionnaire. - Development of cardiovascular events.

NCT ID: NCT06463002 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)

AMPLE
Start date: July 2024
Phase:
Study type: Observational

To compare the blood pressure control and cognitive responses of three groups of patients: those diagnosed with Obstructive Sleep Apnea (OSA) and treated with Continuous Positive Airway Pressure (CPAP) for at least six months, those diagnosed with OSA but not treated, and those without OSA.

NCT ID: NCT06462287 Recruiting - Apnea, Obstructive Clinical Trials

EFFECT OF A SUBSTANCE P ANTAGONIST ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION

APHOS 3
Start date: March 5, 2024
Phase: Phase 2
Study type: Interventional

Obstructive sleep apnea syndrome (OSAS) is associated with hyperaldosteronism with elevated plasma aldosterone/renin ratio, the physiopathological mechanism of which remains uncertain. This hyperaldosteronism contributes to the development of arterial hypertension and cardiovascular complications observed in patients with OSA, in particular by increasing arterial stiffness and heart rate variability. The frequent association of OSA with obesity with metabolic syndrome suggests that excess weight could be responsible for stimulation of aldosterone secretion independent of the renin/angiotensin system. Several studies indicate in particular that the production of mineralocorticoids by the adrenals could be activated by various adipocyte secretion products such as leptin and certain fatty acids after oxidation in the liver. In addition, a recent study showed that basal aldosterone secretion is also controlled by substance P released within the adrenal tissue itself by nerve fibers belonging to the splanchnic contingent. Thus, the oral administration of aprepitant, an antagonist of the substance P receptor (NK1 receptor), to healthy volunteers induces a reduction of approximately 30% in the overall secretion of aldosterone assessed by measuring aldosteronemia and 24-hour aldosteronuria. To the extent that OSA causes sympathetic hypertonia, the hypothesis is that the associated hyperaldosteronism could result from activation of the nervous control of aldosterone secretion, involving substance P and the NK1 receptor. If this is indeed the case, the administration of aprepitant to patients with OSA should result in a significant reduction in aldosteronemia.

NCT ID: NCT06460441 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea Hypopnea Syndrome

Comparison of the SUNRISE© Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome: Collection of Preliminary Data

SUNPV
Start date: June 17, 2024
Phase:
Study type: Observational

Additional data on screening for obstructive sleep apnea/hypopnea syndrome (OSAHS) in patients with co-morbidities, such as diabetics and those with chronic respiratory diseases would enable current recommendations to evolve, with a view to promoting the widespread use of simplified techniques for OSAHS screening, particularly in patients with cardiorespiratory co-morbidities. The primary objective of this observational multicentric pilot study is to compare the performance of the Sunrise® medical device with that of ventilatory polygraphy as part of routine screening for OSAHS in diabetic patients followed up in the diabetology department of the Strasbourg University Hospital, and in patients followed up in the pneumology consultation department of Mulhouse Hospital (GHRMSA).

NCT ID: NCT06458777 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.

Start date: January 19, 2014
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a chronic pathology that affects more than 20% of the adult population. It is one of the main sleep disorders with great clinical, economic and social repercussions. To assess the impact and severity of obstructive sleep apnea, the number of apneas and hypopneas per hour (AHI) is counted. To define that a person has OAS, a sleep study must have an AHI ≥15/h, predominantly obstructive, or the presence of an AHI ≥5/h accompanied by symptoms. The diagnosis of certainty or exclusion, as well as the severity, is established with a sleep study. Polysomnography (PSG) continues to be the gold standard for the diagnosis of OSA, it encompasses the recording of cardiorespiratory and neurophysiological variables, which makes it possible to analyze sleep time and structure, the presence of different respiratory episodes and their repercussions. Respiratory polygraphy (RP) includes recording from a flow sensor, respiratory effort, oxygen saturation, heart rate, and also position but not EEG. There are several studies that have explored the diagnostic agreement of RP versus PSG, being a validated, useful and necessary test for the diagnosis of OSA in different clinical situations. Being cheaper and more accessible. When talking about the diagnosis of OSA, it refers to establishing whether or not there is, the severity and the therapeutic decision that will greatly affect the quality of life, prognosis and day-to-day life of the patient, since it is a chronic disease. It must be borne in mind that most studies are carried out in a field specialized in dream interpretation, so caution must be exercised in interpreting results in another field. PR teams incorporate increasingly better developed software that allows automatic analysis of records, but the technology and algorithms used vary depending on the device, and up to now the AASM continues to recommend manual analysis based on existing evidence. Several studies have examined the agreement between automatic and manual analysis of the PR record or between automatic analysis of PR and PSG. It seems that this agreement is reached above all in the highest AHIs, above 25-30, which may limit its use in clinical practice. For this reason, it is important to carry out a study with a large number of patients to achieve statistical significance, and strong conclusions that support normal clinical practice, and to disable a study that does not meet the scientific requirements when interpreting and reading.

NCT ID: NCT06454318 Completed - Clinical trials for Obstructive Sleep Apnea

Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device

Start date: February 1, 2023
Phase:
Study type: Observational

The goal of this study is to find the best method to use Wellue O2 ring to screen for moderate to severe obstructive sleep apnea. The method that investigators use to screen for moderate to severe obstructive sleep apnea is oxygen desaturation index(ODI). The main questions of this study are 1. What is the best ODI to screen for moderate to severe obstructive sleep apnea? 2. What are the sensitivity, specificity and AUC of the study? In this study, participants are recruited from Sleep center of Thammasat prior to polysomnography. All participants in this study will 1. Undergo polysomnography according to Sleep center of Thammasat protocol 2. Wear Wellue O2 ring when undertaking polysomnography If the polysomnography is switch to PAP titration Wellue O2 ring will be taken out. Data of Oxygen data from Wellue O2 ring are collected and compared with AHI. Investigators will find the best ODI to screen for obstructive sleep apnea.

NCT ID: NCT06453538 Recruiting - Clinical trials for Coronary Artery Disease

Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

UNI-CABG
Start date: February 1, 2023
Phase:
Study type: Observational

To this study is recruiting non- emergency patients to whom are planning to make coronary artery bypass intervention. From all patients are going to examine transthoracic echo, collect blood samples and register overnight sleep polygraph in a qualified sleep laboratory two times; first before cabg and second one after surgery.