Exploring Breathing Patterns

COPD Clinical Trial

— EPISODE  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04754490
• Other study ID #: 256266
• Status: Suspended
• Start date: March 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2021
• Source: Cwm Taf University Health Board (NHS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration

Intervention

Diagnostic Test:
• Speech Recognition
Speech Recognition

Locations

Country	Name	City	State
United Kingdom	Cwm Taf Morgannwg Health Board	Abercynon	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cwm Taf University Health Board (NHS)

Country where clinical trial is conducted

United Kingdom, 

Outcome

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