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临床试验/ACTRN12618001649202
ACTRN12618001649202已完成未知

Feasibility of Using Acoustic Tools for Improved Patient Experience with CPAP therapy

ResMed Ltd0 个研究点目标入组 19 人开始时间: 2018年10月5日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
ResMed Ltd
入组人数
19

研究概览

简要总结

The Mask Identification Clinical Study was a single site pilot study for ongoing product development. Eighteen current PAP therapy users were provided with a new PAP therapy device with an external recording module to collect acoustic signals from their mask for a period of 7 nights. Participants used their device and current mask as normal, and completed a diary entry each night on their bedroom and PAP set-up. The study was conducted to evaluate the feasibility of using acoustic signals to accurately identify mask type in the user home environment. Participants in the study were those currently using CPAP therapy. Eighteen evaluable participants in total were targeted for this study. 6 participants of each of the following PAP mask types; ResMed P10, ResMed N20, ResMed F20. Acoustic signatures do not change significantly over multiple nights for a single patient, nor do they change significantly over time within a single night. However, although visual similarities are apparent, performance of a mask identification algorithm differ when training a machine learning model using controlled (bench) and field data. Training a model with controlled data alone is not representative of the home environment and leads to unsatisfactory classification of mask types from acoustic signatures acquired in the field.

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Patients willing to give written informed consent
  • Patients who can read and write English
  • Patients over 18 years of age
  • Patients established on CPAP therapy
  • Patients currently using an appropriate mask

排除标准

  • Patients using bilevel devices
  • Patients who are using supplemental oxygen
  • Patients who are or may be pregnant
  • Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury
  • Patients who are using another medical device concurrently
  • Patients believed unsuitable for inclusion by the researcher

研究者

发起方
ResMed Ltd

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