Exploring Breathing Patterns (EPISODE)

Exploring Patterns of Speech and Breathing to Indicate the Presence of Obstructive Disease

Study Title Exploring patterns of speech and breathing to indicate the presence of obstructive respiratory disease.

Study Design Prospective Case Control Study Study Participants Participants will be patients attending the respiratory physiology clinic at the Cardiopulmonary Unit, Prince Charles Hospital for an assessment of their lung function. In addition a cohort of control participants without obstructive respiratory disease will be recruited with the assistance of the British Lung Foundation charity.

Planned Size of Sample (if applicable) We have received funding for 52 ½ day sessions and we plan to recruit on average 2 participants per session. As such we aim to recruit a minimum of 100 participants. In addition we are working with the British Lung Foundation to recruit a smaller Cohort of control participants and aim to recruit a minimum of 25 control participants.

Planned Study Period Jan 2019 - Aug 2019 Research Aim(s) This primary objective of this novel study it to create an anonymised database of speech patterns of patients with chronic respiratory disease and healthy aged matched controls for comparison with lung function and medical history.

The primary aims are to:

• Collect breathing patterns from individuals under a range of talking modalities
• Understand how easy it is to gather short speech recordings
• Explore the preferences of patients to be recorded talking

Study Overview

• Status: Suspended
• Conditions: COPD
• Intervention / Treatment: Diagnostic test: Speech Recognition

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Abercynon, Wales, United Kingdom, CF45 4SN
      • Cwm Taf Morgannwg Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patient >18 years old referred for spirometry in the Respiratory Physiology Clinic at Prince Charles Hospital;

Eligibility Criteria - Control Participants Control participants will be contact through the British Lung Foundations local groups who have indicated their willingness to be involved in local clinical research to act as control participants. As all prospective participants will have had their respiratory function measured before taking part by a Respiratory Physiologist, we do not expect to have to screen for medical issues for participation in the study. Furthermore, the actual tests the participants will be undertaking will be non - invasive, submaximal and will require little or no effort.

Description

6.1.2 Inclusion criteria Patient Participants

1. Adult patient >18 years old referred for spirometry in the Respiratory Physiology Clinic at Prince Charles Hospital;
2. Clinically defined obstructive or restrictive respiratory disease (indicated by spirometry)
3. Clinically stable (indicated by being able to undergo spirometry)
4. No significant unstable disease co-morbidities (indicated by being able to undergo spirometry)
5. Capable of providing informed consent.
6. Willing to take part in all study measurements.
7. The speaking exercise will be conducted in English on this study.
8. Participants are not taking part in any other research. 6.1.3 Inclusion criteria Control Participants

1. No obstructive or restrictive respiratory disease (indicated by spirometry) 2. Clinically stable (indicated by being able to undergo spirometry) 3. No significant unstable disease co-morbidity's (indicated by being able to undergo spirometry) 4. Capable of providing informed consent. 5. Willing to take part in all study measurements. 6. The speaking exercise will be conducted in English on this study. 7. Participants are not taking part in any other research.

6.1.4 Exclusion criteria for both Patient and Control Participants

1. Any form of challenge testing in the Respiratory Physiology Department involving salbutamol.
2. Severe Sensory and/or Cognitive Impairment
3. Inability to complete study measurements

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect breathing patterns from individuals under a range of talking modalities	breathing pattern	less than 5 minutes
Understand how easy it is to gather short speech recordings	verbal description	3 minutes
Explore the preferences of patients to be recorded talking	verbal description	3 minutes

Collaborators and Investigators

• Sponsor: Cwm Taf University Health Board (NHS)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 256266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No