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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT06247878 Recruiting - Clinical trials for Obstructive Sleep Apnea

Skiin-PSG Sleep Apnea

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

The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and accelerometry data.

NCT ID: NCT06247631 Recruiting - Clinical trials for Difficult Intubation

STOP-Bang Questionnaire: A Predictor of Obstructive Sleep Apnea and Difficult Mask/Intubation?

Start date: January 10, 2024
Phase:
Study type: Observational

Difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. Obstructive sleep apnea syndrome (OSAS) is a warning sign of difficult airway management. Polysomnography is the gold standard for diagnosis of this syndrome, but the STOP-BANG questionnaire is the preferred screening test. In this study, we wanted to find an answer to the question How successful is the STOP-BANG questionnaire in screening for obstructive sleep apnea syndrome (OSAS) in predicting OSAS, difficult mask and difficult intubation in patients undergoing thoracic surgery?

NCT ID: NCT06239883 Recruiting - Clinical trials for Obstructive Sleep Apnea

This Research Project Studies the Relationship Between OSA and Nocturia.

Start date: June 1, 2019
Phase:
Study type: Observational

The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.

NCT ID: NCT06238362 Recruiting - Clinical trials for Obstructive Sleep Apnea

TheraPAP Equivalence Crossover Study

Start date: March 7, 2024
Phase: N/A
Study type: Interventional

The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.

NCT ID: NCT06189755 Recruiting - Clinical trials for Obstructive Sleep Apnea

MicroRNAs as Biomarkers for Obstructive Sleep Apnea

MIR-OSA
Start date: April 1, 2024
Phase:
Study type: Observational

Although obstructive sleep apnea (OSA) is a common disorder, there are no blood biomarkers for identification and management of these patients. This project will study microRNAs in order to develop and validate blood biomarkers that are specific to OSA, useful for identification of cases with OSA, reflective of efficacy of therapy, and able to predict blood pressure response to treatment of OSA.

NCT ID: NCT06172998 Recruiting - Clinical trials for Obstructive Sleep Apnea

New Perspective on Exploring the Post-apneic BP Surge in Patients With OSA

Start date: April 1, 2022
Phase: Early Phase 1
Study type: Interventional

The nocturnal short-term BPV induced by sleep-breathing events is affected by many factors. The purpose of the study is as follows: (1) to explore the relationship between nocturnal short-term BPV and vascular endothelial function and sympathetic activity in patients with OSA respectively, (2) to explore which play the key role in BP fluctuation, (3) how to prevent the frequent BP fluctuation and arrive at a safe point.

NCT ID: NCT06167369 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Biological and Cognitive Marker of Neurodegeneration in Obstructive Sleep Apnea Patients

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

The goal of this observational study is to investigate biomarkers and neurocognitive markers of neurodegenerative processes in obstructive sleep apnea patients. The main questions the study aims to answer are: - Does neurodegeneration assessed by neurobiological markers and neurocognitive test performance exists in obstructive sleep apnea? - Are these neurodegenerative markers are associated with the adherence to clinical prescribed positive airway pressure therapy? Newly diagnosed patients with obstructive sleep apnea will be observed during the use of clinical prescribed positive pressure therapy. Different study related investigations take place before and six months after treatment start. Researchers will compare after six months the group of adherent treatment participants with the non-adherent treatment participants group to investigate if differences in the observed neurobiological or neurocognitive parameters exist.

NCT ID: NCT06150352 Recruiting - Clinical trials for Obstructive Sleep Apnea

Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment

Start date: September 26, 2023
Phase:
Study type: Observational

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 potentially lead 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 sleep apnea might be modifiable factors to neurocognitive impairment. Positive airway pressure (PAP) is the first line of treatment to maintain open airways for patients with OSA. Improving sleep, sleep apnea and circadian function could be a high-value intervention target to alleviate cognitive impairment and decline in subjects with mild neurocognitive impairment. Amyloid accumulation in brain tissue is a distinct feature of Alzheimers' disease, which is associated with potential impairment of neurocognition clinically. It predicts memory decline in initially cognitively unimpaired individuals. The study explores the associations between sleep apnea, cognitive function and cerebral imaging and the role of PAP therapy on neurocognitive trajectory in these patients with subjective cognitive impairment /mild cognitive impairment (SCI/MCI).

NCT ID: NCT06146101 Recruiting - Clinical trials for Obstructive Sleep Apnea

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA

REPOSA
Start date: May 2, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure. Phase II study will be a 4-week dose-finding study comparing two dose strengths of IHL-42X to placebo. The optimal dose strength will be selected based on comparing the safety and efficacy of the two IHL-42X dose strengths to placebo over a 4-week treatment period. The three treatment groups are; IHL-42X Low dose (2.5mg dronabinol, 125mg acetazolamide), IHL-42X High dose (5mg dronabinol, 250mg acetazolamide) and Placebo. Each treatment group will enrol approximately 40 patients per treatment arm, for a total of approximately 120 patients. The safety and efficacy results of the Phase II study will be used to select the dose strength of IHL-42X and corresponding doses of dronabinol and acetazolamide in Phase III. Phase III study will use the optimal dose strength of IHL-42X identified in Phase II and will be compared to the component active pharmaceutical ingredients at equivalent dose strengths to those found in the IHL-42X optimal dose strength and placebo over 52 weeks. The four treatment groups are; IHL-42X (optimal dose from Phase II), Acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength), Dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) and placebo. The treatment groups will enrol approximately 165 patients in IHL-42X, approximately 55 patients in dronabinol, approximately 55 in acetazolamide, and approximately 165 in placebo, for a total of approximately 440 patients.

NCT ID: NCT06132477 Recruiting - Hypertension Clinical Trials

Impact GLP-1 Agonists Following Bariatric

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.