Entropy-based Physiological Signal Analysis in Patients With Obstructive Sleep Apnoea (EPPOSA)

King's College London

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnoea (OSA)

Treatments: Device: Continuous Positive Airway Pressure Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07406620

366646

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 1 patient group

3DPiPPIn Trial Participants

Description:

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.

Treatment:

Device: Continuous Positive Airway Pressure Therapy