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临床试验/NCT06903481
NCT06903481已完成不适用

Precision Sleep Medicine: Hardware and Software Innovations for the Combined Diagnosis and Treatment of Sleep Apnea at the Point-of-Care

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 1,055 人开始时间: 2022年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,055
试验地点
2
主要终点
Phenotype characterization

研究概览

简要总结

This retrospective observational study aims to characterize the prevalence and clinical features of obstructive sleep apnea (OSA) phenotypes and develop a rater-independent algorithm for automated OSA phenotyping, improving diagnosis and personalized treatment.

详细描述

Obstructive sleep apnea (OSA) is characterized by repeated upper airway blockages during sleep, but it presents with a range of phenotypic variations, each with potentially distinct clinical implications. Current clinical definitions are not always precise, making it difficult to clearly classify patients with overlapping features. This phenotypic overlap poses challenges for understanding the true prevalence of "pure" versus "mixed" OSA phenotypes and their respective clinical implications.

To comprehensively characterize the prevalence and clinical features of distinct OSA phenotypes in a large, diverse patient population, this retrospective study analyzes polysomnography (PSG) data from two publicly available National Sleep Research Resource datasets. The findings are then compared to datasets from the University Hospital Basel and University Children's Hospital Basel to assess generalizability.

Furthermore, the study employs computer-aided analysis of PSG data to develop rater-independent algorithms for objective and automated OSA phenotyping. These advancements aim to improve understanding of OSA heterogeneity, facilitating more precise diagnoses and personalized treatment strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • age 19 years and older (data from University Hospital Basel (USB))
  • age 18 years or younger (data from University Children's Hospital Basel (UKBB))
  • Epworth Sleepiness Scale (ESS) score available (USB only)
  • Diagnosis available (e.g. Obstructive sleep apnea (OSA), Central Sleep Apnea (CSA), Cheyne Stokes Breathing (CSR), ...)
  • signed written general consent

排除标准

  • history of treatment of sleep apnea
  • tracheostomy
  • current home oxygen therapy
  • decline to sign the written general consent, or absence of written general consent

结局指标

主要结局

Phenotype characterization

时间窗: 2025

To characterize the prevalence and clinical features of distinct obstructive sleep apnea (OSA) phenotypes in a large, diverse patient population, polysomnography (PSG) recordings from two publicly available National Sleep Research Resource data collections are analyzed and compared to datasets from the University Hospital Basel (USB) and University Children's Hospital Basel (UKBB) to assess generalizability.

次要结局

  • Computer-aided phenotyping(2025)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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