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临床试验/NCT06789770
NCT06789770招募中不适用

The Impact of Nasal Versus Oral Breathing on Measures of Drug-Induced Sleep Endoscopy

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Classification of route of breathing and upper airway collapsibility during Drug-induced Sleep Endoscopy (DISE)

研究概览

简要总结

This project will provide important new information regarding (1) the relationship between route of breathing and airway collapsibility and (2) whether route of breathing during DISE (Drug-Induced Sleep Endoscopy) is representative of natural sleep.

详细描述

As part of standard of care, a drug-induced sleep endoscopy will be done, where route of breathing will be determined as a percentage of total breaths (during baseline, lateral sleep and maneuver). As part of the research procedure, an in-laboratory Polysomnogram will be conducted as study procedure including a oronasal pressure signal cannula to assess route of breathing.

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
否

入选标准

  • •• Adults (≥ 18yrs) that underwent clinical evaluation at the CPAP Alternatives Clinic at Penn Otorhinolaryngology.
  • •Must have at least mild OSA (AHI>5)

排除标准

  • •• Sleep study with an AHI<5, >25% of total events being central or mixed events, or inability to achieve adequate drug-induced sleep.
  • •Upper Respiratory Illness at the time of the DISE.

结局指标

主要结局

Classification of route of breathing and upper airway collapsibility during Drug-induced Sleep Endoscopy (DISE)

时间窗: Within 3 months of enrollment

Participants will be classified as oral breathers if more than 50% of their total breaths during DISE occur through the oral route; otherwise, they will be classified as nasal breathers. The pattern of upper airway collapse will be characterized using the VOTE classification system, a standardized DISE scoring tool assessing the Velum (V), Oropharynx (O), Tongue Base (T), and Epiglottis (E). Each anatomical site is graded on a 0-2 scale, where 0 = no obstruction, 1 = partial obstruction, and 2 = complete obstruction. This outcome assesses relationships between breathing route classification and the anatomical pattern and severity of upper airway collapse

次要结局

  • Percentage of Oral, Nasal, and Mixed Breathing during DISE and Polysomnography (PSG)(Within 3 months of enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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