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| Name | Class |
|---|---|
| Royal Free Hospital NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure Therapy | Device | 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. |
| Measure | Description | 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 entropy from pre to three months post CPAP therapy | From baseline to three months post-initiation of CPAP therapy |
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Inclusion Criteria:
Exclusion Criteria:
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PAP-naive adults with obstructive sleep apnea (OSA), identified from the Sleep and Ventilation Service at Royal Free London NHS Foundation Trust, who participated in the 3DPiPPIn randomised controlled trial.
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| Name | Affiliation | Role |
|---|---|---|
| Izaak Neri | King's College London | Study Director |
| Stephanie K Mansell | Royal Free London NHS Foundation Trust, University College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Free Hospital | London | NW2 2QG | United Kingdom | |||
| King's College London |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Shah AJ. The use of wearable technology in chronic respiratory disease. Doctor of Philosophy (PhD), University College London; 2025. Available from: https://discovery.ucl.ac.uk/id/eprint/10212804 | ||
| 39542493 | Background | Mansell SK, Mandal S, Ridout D, Olsen O, Gowing F, Kilbride C, Hilton ST, Main E, Schievano S. Clinical impact of customised positive airway pressure (PAP) therapy interfaces versus usual care in the treatment of patients with sleep-disordered breathing (3DPiPPIn): a randomised controlled trial protocol. BMJ Open. 2024 Nov 14;14(11):e087234. doi: 10.1136/bmjopen-2024-087234. | |
| 40728908 |
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The data used in this secondary analysis include potentially re-identifiable patient information. In line with the open access approach of the study's parent trial, 3DPiPPIn, individual participant data will not be shared to protect participant confidentiality.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 | 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). | From baseline to three and/or six months post-initiation of CPAP therapy |
| Relationship between residual Apnoea-Hypopnoea Index and heart rate entropy | 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). | From baseline to three and/or six months post-initiation of CPAP therapy |
| Relationship between residual Apnoea-Hypopnoea Index and heart rate variability entropy | 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). | From baseline to three and/or six months post-initiation of CPAP therapy |
| Relationship between Epworth Sleepiness Scale scores and oxygen saturation entropy | 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). | From baseline to three and/or six months post-initiation of CPAP therapy |
| Relationship between Epworth Sleepiness Scale scores and heart rate entropy | 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). | From baseline to three and/or six months post-initiation of CPAP therapy |
| Relationship between Epworth Sleepiness Scale scores and heart rate variability entropy | 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). | From baseline to three and/or six months post-initiation of CPAP therapy |
| Nocturnal hypoxia (T90) | T90 will be calculated as the percentage of total sleep time during which oxygen saturation is below 90%. T90 values will be categorised according to predefined thresholds to characterise the severity of nocturnal hypoxia. | At baseline, three months and/or six months post-initiation of CPAP therapy |
| London |
| WC2R 2LS |
| United Kingdom |
| Background |
| Mansell SK, Olsen O, Gowing F, Muwaffak Z, Kilbride C, Hilton S, Main E, Schievano S, Mandal S. 3DPiPPIN: 3D printing of positive airway pressure (PAP) therapy interfaces: a single site feasibility study. J Med Eng Technol. 2025 Oct;49(7):293-303. doi: 10.1080/03091902.2025.2532648. Epub 2025 Jul 29. |
| Background | Mansell S, Olsen O, Smith L, Augustt S, Kilbride C, Ridout D, Hilton S, Main E, Schievano S, Mandal S. 3D Printing Positive Pressure Interfaces (3DPiPPIn): Results From a Two-Phase Feasibility Trial [Abstract]. Am J Respir Crit Care Med 2025;211:A6945. doi: 10.1164/ajrccm.2025.211.Abstracts.A6945 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |