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

NCT07406620 | Active Not Recruiting

• 1 other identifier: 366646
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 2

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, 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.

Conditions

Obstructive Sleep Apnoea (OSA)

Keywords

Obstructive Sleep Apnoea; OSA; Continous Positive Airway Pressure; CPAP; Entropy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• 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

• 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 entropy

  From baseline to three and/or six months post-initiation of CPAP therapy

Study Arms (1)

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.

Device: Continuous Positive Airway Pressure Therapy

Interventions

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.

Also known as: CPAP, CPAP Therapy, PAP, PAP Therapy, Positive Airway Pressure Therapy

3DPiPPIn Trial Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (2)

Royal Free Hospital

London, NW2 2QG, United Kingdom

Location

King's College London

London, WC2R 2LS, United Kingdom

Location

Related Publications (4)

• 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

  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.

  PMID: 39542493 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.

  PMID: 40728908 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

  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Izaak Neri

  King's College London

  STUDY DIRECTOR

• Stephanie K Mansell

  Royal Free London NHS Foundation Trust, University College London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MRes Clinical Research Student

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: June 11, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)