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临床试验/NCT06810323
NCT06810323招募中不适用

The Respiratory Oxygen Adherence Monitor System for COPD With Long Term Oxygen Therapy

University of Virginia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
In lab validation study to confirm operation of the device

研究概览

简要总结

The purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. This study will focus on developing a new display part called ROAM module which will be attached to your oxygen source. The display will provide easily-accessible information that can show how you interact with your supplies and the oxygen machine automatically without connecting the oxygen source to the internet or other devices.

详细描述

The Respiratory Oxygen Adherence Monitor (ROAM) system objectively determines the duration and pattern of adherence to oxygen therapy on a minute-by-minute basis and provides feedback of usage metrics to patients and their clinicians. The purpose of the ROAM monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (COPD) and patients requiring long-term oxygen therapy (LTOT), to improve health outcomes in these patients, and to reduce costs that arise from the expensive and preventable exacerbations associated with patient non-adherence. The prevalence of COPD poses an enormous burden to the U.S. healthcare system. LTOT is a well-established treatment for patients with oxygen desaturation due to COPD and other cardiopulmonary diseases. The benefits of adequate adherence to LTOT are substantial both to COPD patients (in terms of reduced morbidity and mortality) and to society (in terms of healthcare cost savings). Despite these benefits, patient adherence to LTOT remains poor. The lack of a method to objectively and reliably quantify LTOT usage complicates the challenge of managing these patients. Furthermore, current adherence metrics (e.g., power-on time) fail to provide information regarding the timing of oxygen use within each 24-hour interval. The ROAM system combines several unobtrusive sensing modalities with adaptive algorithms that detect breathing. In this study, the team will develop a patient-ready product prototype targeted at improving patient LTOT adherence.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Post-Bronchodilator FEV1/FVC <.80
  • Race demographics of the recruitment area reflect the population of the Charlottesville Metropolitan Statistical Area (MSA).
  • Due to underrepresentation in local demographics, special effort (via targeted advertising) will be made to recruit Hispanic participants to better match national percentages.
  • Participants with medical history of COPD
  • Subjects has to have a prescription for oxygen use via nasal cannula or mask at home
  • At baseline of health with no hospitalization/exacerbation within the past 6 weeks
  • Use of Continuous oxygen at baseline

排除标准

  • Post -Bronchodilator FEV1 < 25%
  • Intermittent oxygen use at home
  • Inability to understand simple instructions
  • No respiratory infections and exacerbation within 6 weeks of study

结局指标

主要结局

In lab validation study to confirm operation of the device

时间窗: 2 hour

Repeatability and correlation of the device compared to standard clinical device (pulse ox and heart rate)

次要结局

  • Overnight sleep lab testing while wearing the device to correlate the accuracy of the ROAM device using sleep study results.(Overnight ( 8-12 hours))
  • Long-term ROAM device testing (4 weeks)(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Y. Michael Shim, MD

Professor, Medicine-Pulmonary and Critical Care Medicine

University of Virginia

研究点 (1)

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