Obstructive Sleep Apnoea (OSA)
Conditions
Keywords
Obstructive Sleep Apnoea, OSA, Continous Positive Airway Pressure, CPAP, Entropy
Brief summary
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 variability, and airflow) 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.
Detailed description
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.
Interventions
The intervention of interest within this secondary analysis study is Continuous Positive Airway Pressure (CPAP) Therapy, a device-based treatment used to maintain airway patency in patients with sleep-disordered breathing. As a retrospective study, participant exposure to CPAP occured exclusively within the original 3DPiPPIn trial.
Sponsors
King's College London
Royal Free Hospital NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation in the 3DPiPPIn trial * Completion of the 3DPiPPIn trial to its primary endpoint of six months * Availability of physiological signal data at baseline, three months, and six months * Provision of informed consent permitting the use of their data in future research
Exclusion criteria
* Non-completion of the 3DPiPPIn trial to its primary endpoint of six months * Missing physiological signal data at baseline, three months, or six months * No consent for the use of their data in future research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in oxygen saturation entropy from pre to six months post CPAP therapy | From baseline to six months post-initiation of CPAP therapy |
| Change in heart rate variability entropy from pre to six months post CPAP therapy | From baseline to six months post-initiation of CPAP therapy |
| Change in airflow entropy from pre to six months post CPAP therapy | From baseline to six months post-initiation of CPAP therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change in airflow 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 | The Apnoea-Hypopnoea Index (AHI) is the total number of apnoea and hypopnoea events per hour of sleep. The minimum value is 0 events/hour, and there is no fixed maximum value. Higher scores indicate more severe sleep-disordered breathing (worse outcome). |
| Relationship between residual Apnoea-Hypopnoea Index and heart rate variability entropy | From baseline to three and/or six months post-initiation of CPAP therapy | The Apnoea-Hypopnoea Index (AHI) is the total number of apnoea and hypopnoea events per hour of sleep. The minimum value is 0 events/hour, and there is no fixed maximum value. Higher scores indicate more severe sleep-disordered breathing (worse outcome). |
| Relationship between residual Apnoea-Hypopnoea Index and airflow entropy | From baseline to three and/or six months post-initiation of CPAP therapy | The Apnoea-Hypopnoea Index (AHI) is the total number of apnoea and hypopnoea events per hour of sleep. The minimum value is 0 events/hour, and there is no fixed maximum value. Higher scores indicate more severe sleep-disordered breathing (worse outcome). |
| Relationship between Epworth Sleepiness Scale scores and oxygen saturation entropy | From baseline to three and/or six months post-initiation of CPAP therapy | The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that measures daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome). |
| Relationship between Epworth Sleepiness Scale scores and heart rate variability entropy | From baseline to three and/or six months post-initiation of CPAP therapy | The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that measures daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome). |
| Relationship between Epworth Sleepiness Scale scores and airflow entropy | From baseline to three and/or six months post-initiation of CPAP therapy | The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that measures daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome). |
Countries
United Kingdom
Contacts
CONTACTIme O Umoabasi
STUDY_DIRECTORIzaak Neri
King's College London
STUDY_DIRECTORStephanie K Mansell
Royal Free London NHS Foundation Trust, University College London
Outcome results
None listed