跳至主要内容
临床试验/NCT07422402
NCT07422402已完成不适用

Role of Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Patients With Obstructive Sleep Apnea Syndrome

Mansoura University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
the change in Apnea-Hypopnea Index (AHI) measured by polysomnography

研究概览

简要总结

Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.

详细描述

Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.

DISE-guided management provides significant clinical and polysomnographic improvement in CPAP-intolerant OSA patients. Individualized, anatomy-based therapy enhances treatment precision and outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • OSA confirmed by attended PSG
  • refusal of CPAP therapy.

排除标准

  • Central sleep apnea
  • severe systemic illness
  • significant dental disease
  • pregnancy
  • craniofacial abnormalities
  • temporomandibular joint disorders.

研究组 & 干预措施

Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea

Experimental

evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.

干预措施: Drug induced sleep endoscopy (Procedure)

结局指标

主要结局

the change in Apnea-Hypopnea Index (AHI) measured by polysomnography

时间窗: 3 months

evaluate the the change in Apnea-Hypopnea Index (AHI) measured by polysomnography from baseline to 3 months following DISE-guided allocation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MohamedAbdElmoniem

Lecturer faculty of medicine

Mansoura University

研究点 (1)

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