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临床试验/NCT02331992
NCT02331992已完成不适用

Positive Airway Pressure Program

Fisher and Paykel Healthcare6 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
6
主要终点
Participant Providing Feedback

研究概览

简要总结

Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal.

Over the past decade, considerable research has focused on determining the factors responsible for poor CPAP adherence. Two key areas have been identified: patient-reported symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the importance of patient education and support. In addition we know that the patient experience during the crucial first days and weeks of their journey predicts longer term adherence.

This study investigates the ability of an automated program that assists patients towards continuous positive airway pressure (CPAP) therapy adherence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • ≥ 18years of age
  • Diagnosed with OSA (AHI >5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
  • Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years
  • Own a mobile phone, and has reliable mobile network coverage at their home.
  • Either: the participant will use a modem; OR the participant has access to a home internet connection (either their own, or a neighbours or friend etc) and is willing to perform a home upload.

排除标准

  • Contraindicated for CPAP therapy
  • Medically unstable condition/diagnosis that is not yet under control
  • Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
  • Periodic Limb Movement Arousal Index (PLMA) greater than 15/hr during the diagnostic study

研究组 & 干预措施

Positive airway pressure adherence program

Experimental

Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.

干预措施: Adherence program (Behavioral)

结局指标

主要结局

Participant Providing Feedback

时间窗: 1 month

Participants will be provided questionnaires so as to provide program feedback.

次要结局

  • Healthcare Provider Feedback(1 month)

研究者

发起方
Fisher and Paykel Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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