- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Wales
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Abercynon, Wales, Reino Unido, CF45 4SN
- Cwm Taf Morgannwg Health Board
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Collect breathing patterns from individuals under a range of talking modalities
Periodo de tiempo: less than 5 minutes
|
breathing pattern
|
less than 5 minutes
|
Understand how easy it is to gather short speech recordings
Periodo de tiempo: 3 minutes
|
verbal description
|
3 minutes
|
Explore the preferences of patients to be recorded talking
Periodo de tiempo: 3 minutes
|
verbal description
|
3 minutes
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 256266
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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