This observational study aims at establishing the proportion of patients suffering from endometriosis and for whom an Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis is established.
The study participation will be offered to endometriosis patients displaying symptoms that may suggest an underlying OSAHS.
OSAHS diagnosis will be made according to standard of care practice and patients will be followed up to 12 months after initiating the OSAHS treatment to fill in questionnaires assessing the impact of OSAHS treatment on various endometriosis-related symptoms

开始日期2024-10-01

申办/合作机构

Elsan SAS

NCT06594380 / Not yet recruitingN/AIIT

Observation of Clinical Effect of New Oropharyngeal Airway in Patients With Obstructive Sleep Apnea Hypoapnea Syndrome During Painless Gastroenteroscopy

the(obstructivesleepapneahypoapneasyndromeOSAHS) is a kind of to sleep appear periodically in the process of syndrome characterized by partial or complete obstruction of upper respiratory tract.Patients with obstruction during the attack, faced with percutaneous arterial blood oxygen saturation (percutaneousarterialoxygensaturation, SpO2) to reduce the risk of can also trigger hypercapnia and cardiovascular dysfunction.The global incidence of OSAS is 4.0% in males and 2.0% in females .Sedative drugs inhibit the response of OSAS patients to external stimuli and may cause pharyngeal muscle collapse, leading to an increased risk of respiratory adverse events during painless gastroscopy in this population .In fact, OSAS has been identified as an independent risk factor for endoscopic hypoxia .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia during painless gastroenteroscopy in general patients, the study was designed to investigate the safety and efficacy of the new oropharyngeal airway.

开始日期2024-10-01

申办/合作机构

山东省千佛山医院

ChiCTR2400088350 / SuspendedN/AIIT

Effects of Remazolam on hemodynamics, tracheal intubation stress and agitation during recovery from general anesthesia in patients with OSAHS

开始日期2024-08-18

申办/合作机构-

100 项与阻塞性睡眠呼吸暂停低通气综合征相关的临床结果

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100 项与阻塞性睡眠呼吸暂停低通气综合征相关的转化医学

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0 项与阻塞性睡眠呼吸暂停低通气综合征相关的专利（医药）

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项与阻塞性睡眠呼吸暂停低通气综合征相关的文献（医药）

2024-12-01·Magnetic Resonance Imaging

Neurite Orientation Dispersion and Density Imaging (NODDI) reveals white matter microstructural changes in Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) patients with cognitive impairment

Article

作者: Ning, Ke ; Lin, Yongzhong ; Fan, Dechao ; Liu, Yuzhu ; Liu, Yajie ; Sun, Yubing

PURPOSEThis study aimed to assess changes in white matter microstructure among patients undergoing obstructive sleep apnea hypopnea syndrome (OSAHS) complicated by cognitive impairment through neurite orientation dispersion and density imaging (NODDI), and evaluate the relationship to cognitive impairment as well as the diagnostic performance in early intervention.METHODSTotally 23 OSAHS patients, 43 OSAHS patients complicated by cognitive impairment, and 15 healthy controls were enrolled in OSA, OSACI and HC groups of this work. NODDI toolbox and FMRIB's Software Library (FSL) were used to calculate neurite density index (NDI), Fractional anisotropy (FA), volume fraction of isotropic water molecules (Viso), and orientation dispersion index (ODI). Tract-based spatial statistics (TBSS) were carried out to examine the above metrics with one-way ANOVA. This study explored the correlations of the above metrics with mini-mental state examination (MMSE), and montreal cognitive assessment (MoCA) scores. Furthermore, receiver operating characteristic (ROC) curves were plotted. Meanwhile, area under curve (AUC) values were calculated to evaluate the diagnostic performance of the above metrics.RESULTSNDI, ODI, Viso, and FA were significantly different among different brain white matter regions, among which, difference in NDI showed the greatest statistical significance. In comparison with HC group, OSA group had reduced NDI and ODI, whereas elevated Viso levels. Conversely, compared to the OSA group, the OSACI group displayed a slight increase in NDI and ODI values, which remained lower than HC group, viso values continued to rise. Post-hoc analysis highlighted significant differences in these metrics, except for FA, which showed no notable changes or correlations with neuropsychological tests. ROC analysis confirmed the diagnostic efficacy of NDI, ODI, and Viso with AUCs of 0.6908, 0.6626, and 0.6363, respectively, whereas FA's AUC of 0.5042, indicating insufficient diagnostic efficacy.CONCLUSIONSThis study confirmed that NODDI effectively reveals microstructural changes in white matter of OSAHS patients with cognitive impairment, providing neuroimaging evidence for early clinical diagnosis and intervention.

2024-11-01·Respiratory Medicine and Research

Guidelines for the assessment and management of residual sleepiness in obstructive apnea-hypopnea syndrome

Review

作者: Pépin, Jean-Louis ; Pilette, Charles ; Boutouyrie, Pierre ; Dauvilliers, Yves ; Bequignon, Émilie ; Gagnadoux, Frédéric ; Philip, Pierre ; Patout, Maxime ; Monaca, Christelle ; Geoffroy, Pierre-Alexis ; Andrejak, Claire ; Baillieul, Sébastien ; Barateau, Lucie ; Montani, David ; Tamisier, Renaud ; Trzepizur, Wojciech ; Arnulf, Isabelle ; Micoulaud-Franchi, Jean-Arthur ; Jaffuel, Dany

Excessive daytime sleepiness (EDS) is frequent among patients with obstructive sleep apnea hypopnea syndrome (OSAHS) and can persist despite the optimal correction of respiratory events (apnea, hypopnea and respiratory efforts), using continuous positive airway pressure (CPAP) or mandibular advancement device. Symptoms like apathy and fatigue may be mistaken for EDS. In addition, EDS has multi-factorial origin, which makes its evaluation complex. The marketing authorization [Autorisation de Mise sur le Marché (AMM)] for two wake-promoting agents (solriamfetol and pitolisant) raises several practical issues for clinicians. This consensus paper presents recommendations of good clinical practice to identify and evaluate EDS in this context, and to manage and follow-up the patients. It was conducted under the mandate of the French Societies for sleep medicine and for pneumology [Société Française de Recherche et de Médecine du Sommeil (SFRMS) and Société de Pneumologie de Langue Française (SPLF)]. A management algorithm is suggested, as well as a list of conditions during which the patient should be referred to a sleep center or a sleep specialist. The benefit/risk balance of a wake-promoting drug in residual EDS in OSAHS patients must be regularly reevaluated, especially in elderly patients with increased cardiovascular and psychiatric disorders risks. This consensus is based on the scientific knowledge at the time of the publication and may be revised according to their evolution.

2024-10-01·Neuroscience Bulletin

Altered Cortical Information Interaction During Respiratory Events in Children with Obstructive Sleep Apnea-Hypopnea Syndrome

Article

作者: Liang, Jiuxing ; Shen, Jingxian ; Chen, Jin ; Shi, Naikai ; Lin, Minmin ; Weng, Xuchu ; Pang, Feng

Obstructive sleep apnea-hypopnea syndrome (OSAHS) significantly impairs children's growth and cognition. This study aims to elucidate the pathophysiological mechanisms underlying OSAHS in children, with a particular focus on the alterations in cortical information interaction during respiratory events. We analyzed sleep electroencephalography before, during, and after events, utilizing Symbolic Transfer Entropy (STE) for brain network construction and information flow assessment. The results showed a significant increase in STE after events in specific frequency bands during N2 and rapid eye movement (REM) stages, along with increased STE during N3 stage events. Moreover, a noteworthy rise in the information flow imbalance within and between hemispheres was found after events, displaying unique patterns in central sleep apnea and hypopnea. Importantly, some of these alterations were correlated with symptom severity. These findings highlight significant changes in brain region coordination and communication during respiratory events, offering novel insights into OSAHS pathophysiology in children.

项与阻塞性睡眠呼吸暂停低通气综合征相关的新闻（医药）

2023-04-16

·医药观澜

治疗过度嗜睡，双机制创新疗法在中国获批临床

▎药明康德内容团队报道中国国家药监局药品审评中心（CDE）官网公示，Axsome公司申报的索安非托片获得临床试验默示许可，拟开发用于改善阻塞性睡眠呼吸暂停（OSA）伴有日间过度思睡的成年患者的觉醒程度。公开资料显示，索安非托（solriamfetol，英文商品名为Sunosi）是一种双效多巴胺和去甲肾上腺素再摄取抑制剂，已在美国获批用于治疗与发作性睡病或OSA综合征相关的白天过度嗜睡。截图来源：CDE官网OSA是因为在睡眠过程中气道阻塞，导致频繁出现呼吸暂停的常见疾病，通常伴随着夜间响亮的鼾声。因为呼吸暂停导致大脑缺氧，唤醒患者打开气道，OSA患者往往不能正常睡眠，导致白天出现嗜睡症状。OSA导致的过度嗜睡可能影响患者认知功能，社交关系和生活质量。持续气道正压通气（CPAP）疗法是治疗OSA的有效疗法。然而并不是所有患者都能够忍受CPAP疗法，即时在使用CPAP疗法的患者中，仍然有13%~65%的患者会持续出现嗜睡现象。公开资料显示，索安非托是Jazz Pharmaceuticals开发的一款创新疗法，通过双重机制起到促进患者保持清醒的作用。它能引起多巴胺和去甲肾上腺素水平上升，其中多巴胺可以直接刺激患者大脑中促清醒的神经元，而去甲肾上腺素则可能通过作用于下丘脑腹外侧视前核（VLPO），关闭睡眠的驱动因子。目前其它治疗嗜睡药物大多通过刺激多巴胺释放的方式起作用，由于它们会导致多巴胺水平激增，给患者带来欣快感，因而有上瘾风险。而索安非托不会刺激多巴胺释放，从而减轻患者上瘾的风险。2022年3月，Axsome公司宣布就收购索安非托与Jazz Pharmaceuticals达成最终协议。根据协议条款，Axsome公司将获得Jazz公司拥有的索安非托的开发和商业化权利，而Jazz公司将获得5300万美元的预付款，以及获得在当前和未来适应症中索安非托美国净销售额的特许权使用费。此前，索安非托已在包含多项3期临床试验的TONES研究项目中获得积极临床结果，其中包括治疗OSA患者的TONES 3和TONES 4临床试验，以及评估长期安全性的TONES 5临床试验。数据显示，索安非托不但在临床试验中显著改善了患者的觉醒维持时间和嗜睡评分，同时表现出良好的安全性和耐受性。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Apr 14， 2023, from https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731[2] Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics. Retrieved March 28, 2022, from https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-agreement-to-divest-sunosi-solriamfetol-to-axsome-therapeutics-301511396.html[3] Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea. Retrieved March 19, 2019, from https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-receives-new-pdufa-goal-date-solriamfetol[4]黄丽华, 余勤. 索安非托治疗阻塞性睡眠呼吸暂停低通气综合征所致白天嗜睡的研究进展[J]. 国际呼吸杂志, 2020, 40(23):4.本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期并购临床结果