跳至主要内容
临床试验/NCT04912635
NCT04912635已完成不适用

Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo

ResMed2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ResMed
入组人数
300
试验地点
2
主要终点
Mean CPAP use hours

研究概览

简要总结

This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Participant is at least 18 years old.
  • Participant is using a ResMed AirSense 10 device and ResMed myAir mobile app.
  • Participant has been using CPAP therapy for less than 2 weeks.
  • Participant has been enrolled in myAir for less than 2 weeks.
  • Participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension.
  • Participant owns a mobile device compatible with the Neo app (Android Jelly Bean, v16, 4.1.x or newer, and iOS 8 or newer)
  • Participant is somewhat to fairly confident about being able to use Bluetooth connected devices and apps
  • Participant consents to download the Neo app, Withings app, create a Withings account, and sync Withings data to ResMed's Project Neo.
  • Willing and able to give informed consent
  • Can read and comprehend written and spoken English

排除标准

  • Are participating in another app-based research study
  • Cannot participate for the full duration of the study (at least 45 days)
  • Unable to read or write English
  • Participant is pregnant
  • Participant is on Medicare

结局指标

主要结局

Mean CPAP use hours

时间窗: 6 weeks

Mean PAP use hours (mean hours per day) at 6 weeks following enrollment into the study compared to the control group.

次要结局

  • App Use(6 weeks)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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