NCT Number: NCT07406620
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
King's College London, London, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: CPAP, CPAP Therapy, PAP, PAP Therapy, Positive Airway Pressure Therapy
Time frame: From baseline to six months post-initiation of CPAP therapy
Time frame: From baseline to six months post-initiation of CPAP therapy
Time frame: From baseline to six months post-initiation of CPAP therapy
Time frame: From baseline to three months post-initiation of CPAP therapy
Time frame: From baseline to three months post-initiation of CPAP therapy
Time frame: From baseline to three months post-initiation of CPAP therapy
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At baseline, three months and/or six months post-initiation of CPAP therapy
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.
King's College London
Other
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
Acronym: EPPOSA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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