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临床试验/NCT02331992
NCT02331992
已完成
不适用

Positive Airway Pressure Program

Fisher and Paykel Healthcare3 个研究点 分布在 1 个国家目标入组 34 人2015年2月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sleep Apnea, Obstructive
发起方
Fisher and Paykel Healthcare
入组人数
34
试验地点
3
主要终点
Participant Providing Feedback
状态
已完成
最后更新
7年前

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.

注册库
clinicaltrials.gov
开始日期
2015年2月
结束日期
2015年9月
最后更新
7年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Fisher and Paykel Healthcare
责任方
Sponsor

入排标准

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

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)

研究点 (3)

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