- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00695162
Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
Study Objectives:
- 1. To examine the extent to which noise typical of nursing units reduces speech intelligibility in acutely ill hospitalized patients
- 2. To examine the extent to which noise typical of nursing units impairs recall in acutely ill hospitalized patients
- 3. To quantify severity of reduced performance associated with age, familiarity with the healthcare setting, hearing and health status.
Plan:
One hundred and twenty inpatients from the four medical/surgical nursing units at the Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be recruited to participate in the study. Following assessment to ascertain eligibility and obtaining informed consent, patients will be tested in a sound booth housed at the National Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as his or her own control, we can accommodate considerable baseline variability between patients without adversely affecting required sample size. Patients' performance in speech intelligibility and recall tests will be measured using a constant level of speech, in controlled environments of no noise (baseline), white noise, hospital noise and hospital noise with speech, all delivered via headphones in pseudo-random order. Performance will be measured in each type of noise at decibel levels equivalent to those currently experienced on nursing units and at lower levels that prior studies have shown are more conducive to effective communication
By selecting measures that are particularly relevant to the safe care of hospitalized patients, and that have been studied extensively in healthy populations in highly controlled conditions, we expect to find compelling and unambiguous evidence that hospitalized patients correctly hear and recall very little of what is said to them during their hospitalizations. The majority of hospitalized patients stay on acute care nursing units during most or all of their hospitalizations, making this an appropriate population to study in the context of their responses to the noises typical in these environments. Perhaps most importantly, this study will heighten awareness of health-care personnel to the levels of impairment suffered by their patients - both in their ability to correctly interpret speech and to recall it - in the typical noisy environments of nursing units.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97239
- Portland VA Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Adult inpatients on medical/surgical nursing units at the Portland VA, greater than 18 years of age will be eligible to participate.
Exclusion criteria for 60 participants with hearing impairment:
- Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent
- Patients who are not native American English speakers.
- Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart.
- Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart; 5) patients unwilling to participate.
Exclusion criteria for the other 60 participants:
- Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent
- Patients who are not native American English speakers.
- Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart.
- Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart.
- Patients with hearing loss that exceeds 25 dBHL in any frequency between .l5 and 3 kHz.
- Patients unwilling to participate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: 1
hearing impaired inpatients
|
no noise
noise without speech
noise with speech present
|
Otro: 2
Non-hearing-impaired inpatients
|
no noise
noise without speech
noise with speech present
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in the percent of correctly identified words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent identified in quiet
Periodo de tiempo: immediately after presentation
|
immediately after presentation
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in the percent of correctly recalled words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent recalled in quiet
Periodo de tiempo: five minutes after presentation
|
five minutes after presentation
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Diana S Pope, PhD, MS, RN, Portland VA Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- #11-3307
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. .