NCT04754490

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

February 10, 2021

Last Update Submit

February 10, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Speech RecognitionDIAGNOSTIC_TEST

Speech Recognition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patient \>18 years old referred for spirometry in the Respiratory Physiology Clinic at Prince Charles Hospital;
  • Clinically defined obstructive or restrictive respiratory disease (indicated by spirometry)
  • Clinically stable (indicated by being able to undergo spirometry)
  • No significant unstable disease co-morbidities (indicated by being able to undergo spirometry)
  • Capable of providing informed consent.
  • Willing to take part in all study measurements.
  • The speaking exercise will be conducted in English on this study.
  • \. 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cwm Taf Morgannwg Health Board

Abercynon, Wales, CF45 4SN, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

March 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations