Bronchial AsthmaNCT07060079
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
An observational study of Bronchial Asthma and Bronchiectasis, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma, Bronchiectasis, ILD
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free hospital
London, NW3 2QG
Nawal Alotaibi, Phd student, 02080168375, n.alotaibi@ucl.ac.uk
About this study
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.
Read the detailed description
Sleep is a complex and dynamic interplay between the brain and various physiological systems. Functions such as heart rate, respiration, and brain wave activity are regulated by intricate physiological mechanisms involving nonlinear interactions across multiple control centres operating on different time scales. It is increasingly recognized that a more accurate understanding of physiological outputs can be achieved through nonlinear analytical approaches, rather than traditional linear methods such as the standard deviation of the mean.
Among nonlinear techniques, entropy is one of the most widely used metrics for assessing the irregularity of physiological signals. For example, sample entropy is a method used to quantify regularity in time series data and has demonstrated the ability to distinguish between healthy and diseased individuals. In some cases, recordings from a simple finger pulse oximeter (measuring oxygen saturation (SpO₂)) may be sufficient to screen for sleep apnoea, potentially reducing the need for full cardiorespiratory polygraphy.
While nonlinear methods are well established in cardiovascular research, their application to respiratory signal analysis in obstructive sleep apnoea (OSA) remains limited. This analytical approach may offer deeper insights into complex physiological interactions-such as those between oxygen saturation and heart rate using relatively simple equipment.
The aim of this study is to investigate differences in entropy values between healthy individuals and patients with chronic respiratory diseases, both with and without coexisting sleep-disordered breathing.
- Conditions
- Bronchial Asthma, Bronchiectasis, ILD, COPD, OSAHS, OSA
- Keywords
- SDB, ILD, Entropy, bronchiectasis, COPD, asthma
- Medical subject headings
- Asthma, Bronchiectasis, Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start30 Apr 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060079
- Sponsor's protocol ID
- 345082
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24218531Bhogal 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.
PubMed 28824451
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT07060079
- Acronym / sponsor ID
- 345082
- Conditions
- Bronchial Asthma, Bronchiectasis, ILD, COPD, OSAHS, OSA
- Keywords
- SDB, ILD, Entropy, bronchiectasis, COPD, asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sleep is a complex and dynamic interplay between the brain and various physiological systems. Functions such as heart rate, respiration, and brain wave activity are regulated by intricate physiological mechanisms involving nonlinear interactions across multiple control centres operating on different time scales. It is increasingly recognized that a more accurate understanding of physiological outputs can be achieved through nonlinear analytical approaches, rather than traditional linear methods such as the standard deviation of the mean.
Among nonlinear techniques, entropy is one of the most widely used metrics for assessing the irregularity of physiological signals. For example, sample entropy is a method used to quantify regularity in time series data and has demonstrated the ability to distinguish between healthy and diseased individuals. In some cases, recordings from a simple finger pulse oximeter (measuring oxygen saturation (SpO₂)) may be sufficient to screen for sleep apnoea, potentially reducing the need for full cardiorespiratory polygraphy.
While nonlinear methods are well established in cardiovascular research, their application to respiratory signal analysis in obstructive sleep apnoea (OSA) remains limited. This analytical approach may offer deeper insights into complex physiological interactions-such as those between oxygen saturation and heart rate using relatively simple equipment.
The aim of this study is to investigate differences in entropy values between healthy individuals and patients with chronic respiratory diseases, both with and without coexisting sleep-disordered breathing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 2 months
High entropy value greater irregularity or complexity in the respiratory signal while low entropy value more regular, predictable, or uniform respiratory patterns.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 24218531El 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.
- Results publication: PubMed 28824451Bhogal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma and Bronchiectasis, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nawal Alotaibi (02080168375, n.alotaibi@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07060079, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.