Entropy-Based Assessment of Physiological Signals in Obstructive Sleep Apnoea Patients Pre and Post Continuous Positive Airway Pressure Therapy: A Secondary Analysis of 3DPiPPIn Trial Data
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Change in heart rate entropy from pre to six months post CPAP therapy
研究概览
简要总结
This observational study is being undertaken as a part of a Master of Research (MRes) in Clinical Research programme.
Its goal is to learn about how continuous positive airway pressure (CPAP) therapy changes the complexity of body signals in adults with obstructive sleep apnoea (OSA). The main question it aims to answer is:
- How does the complexity of physiological signals (specifically oxygen saturation, heart rate, and heart rate variability) change in adults with OSA from before to after three and six months of CPAP treatment?
It will use data from individuals who took part in an earlier trial, called 3DPiPPIn, which tested the use of 3D-printed, customised masks CPAP masks through sleep studies.
详细描述
The purpose of this MRes student study is primarily to examine how the entropy, or complexity as measured by entropy, of physiological signals changes in patients with obstructive sleep apnoea (OSA) in response to continuous positive airway pressure (CPAP) therapy.
It is a secondary analysis of data from 3DPiPPIn, a randomised control trial investigating the feasibility of using 3D-printing to develop customised masks for patients receiving positive airway pressure (PAP) therapy.
The hypothesis for this study is that entropy-based measures derived from physiological signals will exhibit changes following CPAP therapy, when compared to pre-therapy measures, reflecting the modulation and restoration of physiological systems that were previously disrupted by OSA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the 3DPiPPIn trial
- •Availability of physiological signal data at baseline and at least one follow-up time point (i.e. three months and/or six months post-CPAP)
- •Provision of informed consent permitting the use of their data in future research
排除标准
- •Non-participation in the 3DPiPPIn trial
- •Absence of physiological signal data at both follow-up time points (i.e. no available data at either three months or six months post-CPAP)
- •No consent for the use of their data in future research
研究组 & 干预措施
3DPiPPIn Trial Participants
Participants were originally recruited to the 3DPiPPIn trial from the Sleep and Ventilation Service at Royal Free London NHS Foundation Trust. The cohort for this secondary analysis comprises adults with sleep-disordered breathing and an Apnoea-Hypopnoea Index (AHI) >15 events/hour who required but had never received PAP therapy, drawn from the trial participants who provided consent for their data to be used in future research.
干预措施: Continuous Positive Airway Pressure Therapy (Device)
结局指标
主要结局
Change in heart rate entropy from pre to six months post CPAP therapy
时间窗: From baseline to six months post-initiation of CPAP therapy
Change in oxygen saturation entropy from pre to six months post CPAP therapy
时间窗: From baseline to six months post-initiation of CPAP therapy
Change in heart rate variability entropy from pre to six months post CPAP therapy
时间窗: From baseline to six months post-initiation of CPAP therapy
次要结局
- Change in heart rate entropy from pre to three months post CPAP therapy(From baseline to three months post-initiation of CPAP therapy)
- Relationship between residual Apnoea-Hypopnoea Index and heart rate entropy(From baseline to three and/or six months post-initiation of CPAP therapy)
- Relationship between Epworth Sleepiness Scale scores and heart rate entropy(From baseline to three and/or six months post-initiation of CPAP therapy)
- Nocturnal hypoxia (T90%)(At baseline, three months and/or six months post-initiation of CPAP therapy)
- Change in oxygen saturation entropy from pre to three months post CPAP therapy(From baseline to three months post-initiation of CPAP therapy)
- Change in heart rate variability entropy from pre to three months post CPAP therapy(From baseline to three months post-initiation of CPAP therapy)
- Relationship between residual Apnoea-Hypopnoea Index and oxygen saturation entropy(From baseline to three and/or six months post-initiation of CPAP therapy)
- Relationship between residual Apnoea-Hypopnoea Index and heart rate variability entropy(From baseline to three and/or six months post-initiation of CPAP therapy)
- Relationship between Epworth Sleepiness Scale scores and oxygen saturation entropy(From baseline to three and/or six months post-initiation of CPAP therapy)
- Relationship between Epworth Sleepiness Scale scores and heart rate variability entropy(From baseline to three and/or six months post-initiation of CPAP therapy)
研究者
Ime Umoabasi
MRes Clinical Research Student
King's College London