- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04754490
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
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Wales
-
Abercynon, Wales, Storbritannien, CF45 4SN
- Cwm Taf Morgannwg Health Board
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Testmetod
Studera befolkning
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.
Beskrivning
6.1.2 Inclusion criteria Patient Participants
- 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.
- 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
- Any form of challenge testing in the Respiratory Physiology Department involving salbutamol.
- Severe Sensory and/or Cognitive Impairment
- Inability to complete study measurements
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Collect breathing patterns from individuals under a range of talking modalities
Tidsram: less than 5 minutes
|
breathing pattern
|
less than 5 minutes
|
|
Understand how easy it is to gather short speech recordings
Tidsram: 3 minutes
|
verbal description
|
3 minutes
|
|
Explore the preferences of patients to be recorded talking
Tidsram: 3 minutes
|
verbal description
|
3 minutes
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 256266
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .