- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05029986
Preventing Dyspnea During Speech in Older Speakers
Self-Regulated Airflow Management in Daily Communicative Activities to Prevent Dyspnea During Speech in Older Speakers
Due to various comorbidities affecting the respiratory system, older speakers are at risk of experiencing breathing discomfort (dyspnea) during high-demand vocal activities such as singing, loud speaking, and speaking while exercising. Dyspnea during speech can promote avoidance of certain situations involving voice production, thus leading to vocal deconditioning and decreased quality of life. The goal of this pilot study is to test the feasibility and acceptability of a 4-week remote group intervention targeting phonatory dyspnea, and to gather preliminary efficacy data.
Participants will receive an intervention including a 2-week socialization phase (control condition) and a 4-week speech breathing intervention phase (experimental condition). Both phases will be delivered remotely and in a group setting (10 participants per group).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- University of Delaware
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- sign the informed consent form
- report dyspnea in at least one of the items of the University of Cincinnati Dyspnea Questionnaire referring to speech
- be available during the dates of the scheduled group interventions
- be aged 50 years or older
Exclusion Criteria:
- do not have access to a computer and internet connection
- present with a known voice pathology (other than age-related vocal fold atrophy) and/or are receiving speech therapy at the time of the study
- have a known neurodegenerative disease affecting speech/voice
- are a current smoker
- are receiving pulmonary rehabilitation at the time of the study or are starting a new medication regimen for a respiratory disease at the time of study onset;
- have a hearing loss that is not adequately managed, as judged by the Principal Investigator (PI)
- have professional vocal training [amateur choir singers will not be excluded]
- cannot provide informed consent or easily follow instructions
- have any other condition that precludes them from participating in the behavioral interventions, as judged by the PI.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: All participants
This is a single-arm trial.
All participants will receive (1) a control condition (socialization phase, 2 weeks) and (2) an intervention condition (speech breathing intervention, 4 weeks).
Group sessions will take place once a week, and participants will be instructed to practice their exercises every day at home during the study duration.
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Control condition: does not involve speech-related exercises
Experimental condition: involves speech-related exercises
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in reported dyspnea
Periodo de tiempo: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Participant self-ratings of dyspnea on the University of Cincinnati Dyspnea Questionnaire.
This questionnaire contains 30 items scored on a Likert scale ranging from 1 (not at all short of breath) to 5 (always short of breath or cannot do).
A higher scores indicates greater shortness of breath and therefore greater handicap.
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Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Change in reported voice handicap
Periodo de tiempo: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
|
Participant self-ratings of voice handicap on the Voice Handicap Index-10.
The Voice Handicap Index-10 is an ordinal scale that measures the degree of handicap a person experiences because of their voice disorder.
Each item is scored on a Likert scale ranging from 0 to 4. The minimum score is 0 and the maximal score 40.
A higher score indicates a greater perceived voice handicap.
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Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in reported self-efficacy
Periodo de tiempo: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Participant self-ratings of self-efficacy for managing their symptoms, using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Questionnaire - Managing Symptoms.
This questionnaire contains 28 items, each scored on a Likert scale ranging from 1 (I am not at all confident) to 5 (I am very confident).
A higher score indicates a greater self-efficacy.
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Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.
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Acceptability of the intervention
Periodo de tiempo: Assessed after the 4-week experimental condition, at the end of the study period.
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Participants' perceived acceptability of the intervention using the Acceptability of Intervention Measure.
This questionnaire contains 5 items scored on a Likert scale ranging from 1 (completely disagree) to 5 (completely agree).
A higher score indicates a greater acceptability.
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Assessed after the 4-week experimental condition, at the end of the study period.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1767412
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.
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