The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease

NCT07060079 | Recruiting

• 1 other identifier: 345082
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Research is being conducted into chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, and bronchiectasis. The investigation specifically focuses on sleep-disordered breathing (SDB) in individuals with chronic respiratory disease. SDB encompasses a range of conditions, the most common of which is obstructive sleep apnoea. In obstructive sleep apnoea, periodic pauses in breathing (apnoea) lead to reduced blood oxygen levels. To detect these events, patients typically undergo sleep studies that involve monitoring oxygen saturation, heart rate, and respiratory patterns during sleep. When chronic respiratory disease and SDB coexist, breathing disturbances during sleep may be exacerbated. To identify SDB, sleep studies are commonly used to assess oxygen levels, heart rate, and breathing patterns. The objective of this research is to identify differences between patients with chronic respiratory diseases who have SDB and those who do not. This will be achieved by analysing sleep study data using a novel analytical approach. The aim is to determine whether this method can yield more detailed insights into the underlying pathophysiology of these conditions.

Conditions

Bronchial Asthma; Bronchiectasis; ILD; COPD; OSAHS; OSA; Obesity Hypoventilation Syndrome (OHS)

Keywords

SDB; ILD; Entropy; bronchiectasis; COPD; asthma

Outcome Measures

Primary Outcomes (1)

• Changes in respiratory signals entropy, oxygen saturation , and heart rate recorded using cardiorespiratory polygraphy during a 1-hour daytime and overnight sleep in healthy subjects and patients with chronic respiratory diseases with /without SDB.

  High entropy value greater irregularity or complexity in the respiratory signal while low entropy value more regular, predictable, or uniform respiratory patterns.

  2 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Royal Free Hospital in London over a period of 18 months. They will be approached during sleep or respiratory clinics attending and from an existing clinical database

You may qualify if:

• All adult patients (≥ 18years) with chronic respiratory disease with/without SDB.
• patients who have had previously negative studies as a control group.
• Subject is able to read, understand, and sign the informed consent form.
• Willing to sleep with portable monitoring devices.

You may not qualify if:

• Patients who are under 18 years of age at the time of the index study.
• Contraindications to the use of portable monitoring.
• Inability to give informed consent to take part in the study.

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Free hospital

London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (2)

• El Shayeb M, Topfer LA, Stafinski T, Pawluk L, Menon D. Diagnostic accuracy of level 3 portable sleep tests versus level 1 polysomnography for sleep-disordered breathing: a systematic review and meta-analysis. CMAJ. 2014 Jan 7;186(1):E25-51. doi: 10.1503/cmaj.130952. Epub 2013 Nov 11.

  PMID: 24218531 BACKGROUND

• Bhogal AS, Mani AR. Pattern Analysis of Oxygen Saturation Variability in Healthy Individuals: Entropy of Pulse Oximetry Signals Carries Information about Mean Oxygen Saturation. Front Physiol. 2017 Aug 2;8:555. doi: 10.3389/fphys.2017.00555. eCollection 2017.

  PMID: 28824451 RESULT

MeSH Terms

Conditions

Asthma; Bronchiectasis; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hypoventilation; Respiratory Insufficiency; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Nawal Alotaibi

CONTACT

02080168375; n.alotaibi@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 11, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)