Breathlessness Perceptions Within Respiratory Diseases

NCT07648082 | Recruiting DMC

• 2 other identifiers: 172675NIHR203327
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Breathlessness is a complex symptom that results in poor quality of life, increased hospitalisations and increased mortality. Breathlessness is influenced by physiological, psychological and functional factors but these are poorly explored. There are also unexplored phenomenon's such as breathing pattern. Therefore, this study aims to understand the influences of physiology, psychology, function and breathing pattern on health related quality of life in those with a respiratory disease compared to healthy controls. This project is a cross-sectional cohort study including those with a known respiratory disease and experiencing breathlessness, compared to non-breathless healthy controls. The investigators will measure your physiology through spirometry (a breathing test that tells us about their lung function), psychology through questionnaires, function through an exercise test and breathing pattern using opto-electrictronic plethysmography (markers are placed on your chest to see how participants breathe while exercising). This will be conducted over two visits. The investigators will recruit participants from clinics at the University Hospitals of Leicester NHS Trust. The investigators are aiming to recruit 50 participants with a respiratory disease and 25 healthy controls. The results of this study will help us understand breathlessness in more detail in order to be able to develop better treatments.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Asthma (Diagnosis); Interstitial Lung Disease (ILD); Bronchiectasis; Breathing Pattern Disorder

Keywords

Breathlessness; OEP; Cardiopulmonary Exercise Testing; Respiratory diseases; Heart rate variability; Breathing patterns

Outcome Measures

Primary Outcomes (1)

• Breathing pattern regional contribution parameters

  Optoelectronic plethysmography allows to quantify how different thoracic compartments contribute to the overall tidal volume through regional contribution parameters. These regional contributions are expressed as percentages.

  From June 2025 to July 2026

Secondary Outcomes (31)

• Breathing pattern-Timing parameters-Recording duration

  From June 2025 to July 2026

• Breathing pattern-Timing parameters- Sampling frequency rate

  From June 2025 to July 2026

• Breathing pattern-Timing Parameters- Number of respiratory cycles analysed

  From June 2025 to July 2026

• Breathing pattern-Ratio parameters-Compartmental contributions

  From June 2025 to July 2026

• Breathing pattern- Phase angle parameters

  From June 2025 to July 2026

Study Arms (1)

50 participants with a respiratory disease and 25 health controls will be recruited.

Inclusion criteria is: * Aged 18 or over up to 100 * Known respiratory diagnosis\* OR Healthy control\*\* * Ongoing symptoms of breathlessness defined as ≥2 MRC dyspnoea scale * Able to communicate in English * Able to attend two study visits * Able to provide written informed consent * Known respiratory diagnosis could include, but is not limited to, Chronic Obstructive Pulmonary Disease, Asthma,Bronchiectasis or Interstitial Lung Disease. * Healthy controls are required to have an absence of a functionally limiting condition such as respiratory, cardiovascular, or musculoskeletal. Participants are excluded if,: * Unstable disease or undergoing investigations for unexplained symptoms * Undergone a surgery within past six weeks * Contraindications for exercise outlined by American College of Sports Medicine guidelines (Unstable Cardiovascular disease, hypertension etc) * Body Mass Index ≥ 35kg/m2 * Unable to communicate in English * Unable to provide consent

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Males and Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a healthy group and a disease group. The disease group will have a known respiratory condition such as COPD, Asthma, ILD or Bronchiectasis. The healthy group will not have any functionally limiting conditions interms, cardiorespiratory and muskuloskeletal.

You may qualify if:

• Aged 18 or over up to 100
• Known respiratory diagnosis\* OR Healthy control\*\*
• Ongoing symptoms of breathlessness defined as ≥2 MRC dyspnoea scale
• Able to communicate in English
• Able to attend two study visits
• Able to provide written informed consent
• Known respiratory diagnosis could include, but is not limited to, COPD, Asthma, Bronchiectasis or ILD.
• Healthy controls are required to have an absence of a functionally limiting condition such as respiratory, cardiovascular, or musculoskeletal.

You may not qualify if:

• Unstable disease or undergoing investigations for unexplained symptoms
• Undergone a surgery within past six weeks
• Contraindications for exercise outlined by ACSM guidelines (Unstable CVD, hypertension etc)
• BMI ≥ 35kg/m2
• Unable to communicate in English
• Unable to provide written informed consent
• Unable to abstain from smoking for 8 hours prior to testing

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Related Publications (3)

• Pritchard A, Burns P, Correia J, Jamieson P, Moxon P, Purvis J, Thomas M, Tighe H, Sylvester KP. ARTP statement on cardiopulmonary exercise testing 2021. BMJ Open Respir Res. 2021 Nov;8(1):e001121. doi: 10.1136/bmjresp-2021-001121.

  PMID: 34782330 BACKGROUND

• Oxley R, Macnaughton J. Inspiring change: humanities and social science insights into the experience and management of breathlessness. Curr Opin Support Palliat Care. 2016 Sep;10(3):256-61. doi: 10.1097/SPC.0000000000000221.

  PMID: 27490147 BACKGROUND

• Hayen A, Herigstad M, Pattinson KT. Understanding dyspnea as a complex individual experience. Maturitas. 2013 Sep;76(1):45-50. doi: 10.1016/j.maturitas.2013.06.005. Epub 2013 Jul 10.

  PMID: 23849705 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Disease; Lung Diseases, Interstitial; Bronchiectasis; Dyspnea; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Enya Daynes, PhD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enya Dr. Daynes, PhD

CONTACT

0116 273 0333; e.daynes@nhs.net

Iridu Udanthi Basnayake, MSc

CONTACT

0116 273 0333; iub3@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: June 15, 2026
• Study Start: June 6, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Start Date -June 2025 to June 2030
• Access Criteria: The study team will be able to access the data.

Locations

GB (1)