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临床试验/NCT06525857
NCT06525857招募中不适用

Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1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
40
试验地点
1
主要终点
SpO2 changes from before and during LTOT

研究概览

简要总结

In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.

For this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Age ≥ 18-year-old, and
  • Chronic respiratory disease including a) chronic obstructive pulmonary disease, b) interstitial lung disease, c) pulmonary hypertension, d) bronchiectasis, and
  • Prescribed new LTOT due to a chronic respiratory disease with resting and/or exertional hypoxemia, and
  • Able to speak/read/understand German or French, and
  • Willing and able to understand and provide signed informed consent

排除标准

  • Pregnant or lactating women, or
  • Inability to follow the procedures/instructions of the study (e.g. due to language, psychological disorders, dementia, etc.), or
  • Patients having a subordination link to the investigators, or
  • Patients with isolated nocturnal oxygen therapy or LTOT prescription for a heart disease, sleep associated breathing disorder, neuromuscular disease or lung cancer, or
  • Known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.

结局指标

主要结局

SpO2 changes from before and during LTOT

时间窗: From 1 week before start of LTOT to 1 month after start of LTOT

Record SpO2 (%) to compare before and during LTOT

Respiratory rate changes from before and during LTOT

时间窗: From 1 week before start of LTOT to 1 month after start of LTOT

Record respiratory rate (breaths per minute) to compare before and during LTOT

Heart rate changes from before and during LTOT

时间窗: From 1 week before start of LTOT to 1 month after start of LTOT

Record heart rate (BPM) to compare before and during LTOT

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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