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临床试验/NCT07370376
NCT07370376已完成不适用

Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients

研究概览

简要总结

Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity.

详细描述

Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity. The aim of the study is to evaluate diaphragmatic function in OSA patients using ultrasonography and to investigate its relationship with OSA severity and sleep-related parameters.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria:
  • Age 18-65 years.
  • Willingness to participate in the study.

排除标准

  • Patients were excluded if they had any of the following conditions:
  • Refusal to participate in the study
  • Age <18 or >65 years
  • Systemic organ failure, including heart failure, stroke, renal failure, or liver failure; Uncontrolled diabetes mellitus
  • Diagnosed obesity hypoventilation syndrome (OHS) or other sleep disorders apart from OSA
  • Chronic respiratory diseases such as COPD, bronchial asthma, or restrictive lung disease
  • OSA patients already receiving therapy (CPAP, oral appliances, or upper airway surgery)
  • Neuromuscular disorders or other conditions affecting diaphragmatic function (malnutrition, chest trauma, or immobility)
  • Use of steroids or uncontrolled autoimmune diseases.

研究组 & 干预措施

newly diagnosed OSA patients (AHI ≥5)

30 newly diagnosed OSA patients (AHI ≥5). All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF).

non-OSA controls (AHI <5)

All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF).

结局指标

主要结局

Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients

时间窗: 6 months

All participants underwent diaphragm thickening fraction (DTF) as a percentage (%)

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 of chest medicine

Mansoura University

研究点 (1)

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