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临床试验/NCT06851351
NCT06851351已完成不适用

Study of Respiratory Restriction in Patients With Prader-Willi Syndrome

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Rib cage contribution to ventilation

研究概览

简要总结

The main aim of this study is therefore to evaluate the impact of Prader Willi Syndrome (PWS) on lung and thoracoabdominal volumes, respiratory muscle strength and awake ventilatory pattern, and to quantify and localize the PWS-induced respiratory restriction.

详细描述

The aim is to study lung function in obese PWS patients using both volitional (spirometry, nitrogen wash-out, and maximal pressure measurements (MIP and MEP)) and non-volitional (awake ventilatory pattern by opto-electron plethysmography) tests, both in sitting and supine positions.

Spirometry, nitrogen wash-out, and MIP and MEP measurements are comprehensive assessments, while optoelectronic plethysmography allows restriction location through accurate measurement of thoracoabdominal volumes.

The results of the study could provide useful information about the calculation of the volumes enclosed by the grid of markers (in particular, the volume of the rib cage, which reflects the action of the intercostal muscles, the volume of the abdomen, which reflects the action of the diaphragm in the inspiratory phase and of the abdominal muscles during exhalation and their sum, which represents the total variation of the thoraco-abdominal wall. All these finds could be useful for respiratory rehabilitation protocols for obese PWS patients.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-50 years
  • Prader Willi Syndrome
  • Body Mass Index > 30 kg/m2

排除标准

  • Lack of signed consent form
  • Control subjects
  • Inclusion Criteria:
  • Age 20-50 years
  • Body Mass Index < 25 kg/m2
  • Exclusion Criteria:
  • Lack of signed consent form

结局指标

主要结局

Rib cage contribution to ventilation

时间窗: At enrollment

Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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