Clinical trial NCT04754490: Exploring Breathing Patterns
Official title: Exploring Patterns of Speech and Breathing to Indicate the Presence of Obstructive Disease
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: COPD
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
First posted: 2021-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Collect breathing patterns from individuals under a range of talking modalities
timeFrame: less than 5 minutes
measure: Understand how easy it is to gather short speech recordings
timeFrame: 3 minutes
measure: Explore the preferences of patients to be recorded talking
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Abercynon
country: United Kingdom
facility: Cwm Taf Morgannwg Health Board
state: Wales
Study officials:
References: