Clinical Research Directory

Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized by recurrent collapse of the upper airway during sleep, in which the palatopharyngeal muscle plays a key role in pathophysiology. Although continuous positive airway pressure (CPAP) remains the standard treatment, adherence is often suboptimal. Botulinum toxin type A (BoNT-A), a peripheral neuromodulator, has been proposed as a potential therapeutic alternative by inducing chemodenervation and muscle volume reduction, thereby potentially increasing upper airway patency. This study aims to evaluate the efficacy and safety of BoNT-A injection into the palatopharyngeal muscle in patients with moderate to severe OSA. This is a prospective, single-arm, interventional clinical trial with pre- and post-intervention assessment. We hypothesize that the intervention will result in a significant reduction in the Apnea-Hypopnea Index (AHI), along with improvements in secondary outcomes such as excessive daytime sleepiness and oxygenation parameters.

Semaglutide Effects on Sleep Apnea in Patients With Type 2 Diabetes/Obesity and Comorbid Obstructive Sleep Apnea

Semaglutide (a GLP-1RA) is approved for type 2 diabetes mellitus T2DM and obesity, but its effect on obstructive sleep apnea OSA remains unclear. To evaluate changes in Apnea-Hypopnea Index (AHI) after 1-week and 4-week semaglutide treatment in T2DM/obesity patients with OSA, we conducted a single-center real-world study (RWS) of 15 patients. Outcomes assessed included AHI, weight, BMI, blood pressure, blood glucose(fasting blood glucose, glycated albumin),liver function, blood lipids, waist circumference, and other metabolic parameters, to provide real-world evidence for semaglutide in OSA management.

Personalised Treatment for OSA

Obstructive sleep apnea (OSA) is a sleep disorder characterized by repetitive episodes of partial or complete obstruction of the upper airway during sleep. Continuous positive airway pressure (CPAP) is a method used as a first-line treatment for obstructive sleep apnea (OSA). However, intolerance and resistance to CPAP can limit its long-term effectiveness. Alternative treatments are available, such as Mandibular Advancement Devices (MADs), positional therapy, upper airway surgery, and maxillomandibular osteotomy. However, often less efficient in reducing the apnea-hypopnea index, the higher tolerance of and compliance to alternative treatment has resulted in the adequate treatment of OSA in CPAP-intolerant patients. This paper describes the protocol of a prospective single-center cohort study including adult patients with moderate to severe OSA (15 events/h ≤ apnea-hypopnea index (AHI) \< 65 events/h) that failed to comply with CPAP therapy. Selected patients will be invited to the clinic to explore alternative treatment options where DISE will be a first step in further identifying upper airway collapse during sleep. By exploring alternative treatment options in CPAP-intolerant patients and systematically documenting their treatment paths, an algorithm can be defined to better guide patients towards personalized treatment for OSA. The follow-up is aimed at 5 years with an inclusion of 170 patients per year, including a drop-out rate of 15%. By leveraging a real-world database, this study aims to bridge the gap between research and clinical practice, facilitating the development of evidence-based guidelines and personalized treatment algorithms for CPAP-intolerant patients.

The Impact of Non-motor Symptom on the Outcome of Stroke Subjects

The most common symptoms of stroke were focal weakness, hemiparesis, speech disturbance, diplopia and ataxia. Beside those symptoms, there are still many symptoms occurring after stroke, which may affect the life quality of participants. Compared to motor symptoms, the study of these non-motor symptoms was too small. At present, the most reported non-motor symptoms after stroke are sleep disorder, depression and post-stroke pain. There are still many symptoms that were not investigated. The study investigates the prevalence of non-motor syndromes in acute ischemic stroke patients and the impact of these syndromes on the outcome of ischemic stroke patients. The non-motor syndromes that were researched include dizziness, pain, skin lesions, sensory impairment, fever, infection, delirium, depression, insomnia, confusion, delirium and headache. Delirium may occur after stroke. Delirium may impair the mentality, thinking, attention and consciousness level of participants. There are many causes reported attributed to confusion including infection, old age, stroke, hemorrhage… Early diagnosis and early treatment for confusion may improve outcome and decrease mortality in stroke populations. One of the aims of the study is to investigate the prevalence, causes and outcome of treatment in stroke populations who hospitalized to the hospital. Fatigue is a feeling of tiredness or lack of energy. Fatigue is not the same as the feeling drowsy or sleepy. When a person is fatigued, they lose motivation and energy. Fatigue may be mild to severe. It may be related to a physical or mental health condition. The study investigates the prevalence and impact of fatigue on stroke populations' outcomes. In depression, a person experiences a loss of pleasure or interest in activities and feels sad, irritable, and empty. Post-stroke depression is common. When a stroke person has a depressed mood, they may have no motivation for activity. This may interfere with physical therapy and affect the outcome of a stroke. The study investigates post-stroke depression prevalence and impact. The study investigates the prevalence and impact of sleep apnea on stroke outcome.

The SNORE-trial: Analysis of Alterations in Sleep Stages Following Anesthesia and Their Relation to the Severity of Obstructive Sleep Apnea in the First 3 Nights After Surgery

The goal of this observational study is to learn about the relationship between sleep alterations following anesthesia and their relationship to a potential increase of obstructive sleep apnea (OSA) severity. Our main question is: Is there an increased severity of OSA on the third post-operative night compared to the first post-operative night and does this have a relation with REM sleep? Participants enrolled in this research are all diagnosed with OSA, with or without treament. All participants will be asked to wear a watchlike device called WATCHPAT to identify sleep paterns and register apneic (no breathing) and hypopneic (insufficient breathing) incidents. We ask our participants to wear this device for 8-10 hours a night when they are a sleep.