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临床试验/NCT03832244
NCT03832244已完成不适用

The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales

Bartin State Hospital1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2019年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
199
试验地点
1
主要终点
Retropalatal distance

研究概览

简要总结

The investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales.

详细描述

Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA). However, the availability of PSG is limited, particularly in developing and / or least developed countries. Sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use.

The investigators aimed to perform sub-mental ultrasonography to the patients who underwent to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA scales.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Patient who consented for sub-mental ultrasound

排除标准

  • Any pharyngo laryngeal anatomic abnormality
  • Previous history of Obstructive sleep apnea treatment
  • Previous history of surgical intervention to the pharyngo laryngeal anatomic area

结局指标

主要结局

Retropalatal distance

时间窗: Baseline

The diameter of retropalatal space in the transverse dimension

Distance between lingual arteries

时间窗: Baseline

Distance between lingual arteries in the transverse plane

Tongue base thickness

时间窗: Baseline

The closest distance between tongue base and the skin in the sagittal plane

次要结局

  • Berlin Questionnaire(Baseline)
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline)
  • Neck circumference(Baseline)
  • The thyromental distance(Baseline)
  • Stop-Bang questionnaire(Baseline)

研究者

发起方
Bartin State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ozgeyagcioglu Yassa

Principal Investigator

Bartin State Hospital

研究点 (1)

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