The Use of Wearable Technology to Acquire Signals for COPD Research

NCT04495062 | Completed

• 1 other identifier: 19/NI/0194
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition which affects approximately 3 million people in the UK and 210 million worldwide. The disease is characterized by progressive air flow obstruction and decline of lung function. COPD is currently the fourth leading cause of death in the world. The main reason for hospitalisations associated with COPD is exacerbations (chest infections or a worsening of the underlying symptoms). Severe COPD exacerbations are the second largest cause of emergency admissions in the UK. Mild and moderate exacerbations can be managed in the community but if they are not identified promptly they may progress to breathlessness and in some patients to respiratory failure. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority for current and future COPD research. However, these still do not exist. The aim of this study will be to acquire acoustic respiratory signals from COPD patients with a small wearable device. These signals will be subsequently used to carry out engineering research with the objective of trying to find "fingerprints" in them which could be early indicators of disease exacerbations. If those "fingerprints" were found, subsequent research could focus on trying to create software methods which, together with the use of a small wearable device, would aim at automatically detecting exacerbations when they are at very early stages- prior to the symptoms being evident to the patient- so that clinical intervention could be triggered, in order to optimize the disease outcomes.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The primary objective of this work is to acquire acoustic signals from two groups of COPD patients, that can subsequently be used to carry out COPD signal processing research.

  Acoustic signals from wearable technology will be collected from stable COPD patients but also patients with an exacerbation of COPD and the signals analysed for changes

  Signals will be recorded for a maximum of 4 weeks

Secondary Outcomes (1)

• To explore the usability aspects of a small wearable device in the context of COPD patients

  2 patient visits lasting a maximum 1 hour.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a proven diagnosis of chronic obstructive pulmonary disease

You may qualify if:

• Patients with a diagnosis of COPD (FEV1:FVC \<0.7)

You may not qualify if:

• Age \< 18 or \>80years
• Subjects who are not fluent in English, or who have special communication needs.
• Known allergy to the adhesive dressing.
• For the stable patients, subjects with physical or mental impairments who would not be able to use the new technology on their own.
• Subjects with very loose/saggy skin in the neck area which would unavoidably result in the device swinging if moving the neck.
• Subjects with implantable devices
• Subjects with known sleep disordered breathing
• Subjects with stridor
• Subjects requiring ventilation
• Subjects unable to give consent

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Imperial College London: collaborator
• Acurable Ltd.: collaborator

Study Sites (1)

Academic Respiratory Department Royal Free Hospital NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

GB (1)