- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03932383
3D Printer Modified CPAP Mask for Obstructive Sleep Apnea (3DCPAP)
3-D Printer Custom Modified Continuous Positive Airway Pressure Masks to Improve Efficacy and Patient Compliance in Obstructive Sleep Apnea Management
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Purpose:
The purpose of this protocol is to perform a prospective pilot clinical study to customize patient CPAP masks to reduce air leak in patients with obstructive sleep apnea (OSA). Using 3-D printer-based technology modeling of patient facial features, patient FDA-approved CPAP masks will be modified by strategically applying silicone pads on the CPAP mask to mold to the specific facial features to optimize the CPAP mask-patient interface, improve CPAP mask fit and comfort, reduce air leak, limit air pressure loss and improve compliance with CPAP treatment strategy (as measured over a 30 day trial period).
Protocol:
Potential subjects for this study will be identified at the outpatient Sleep Disorders Clinic at BIDMC. Patients will have documented OSA, prescribed CPAP as standard-of-care, and demonstrate consistent problems with CPAP mask-patient interface with documented high air loss, and poor adherence/ compliance. All potential subjects will have used and will continue to use an FDA-approved CPAP mask selected by the patient.
Potential subjects (along with their FDA-approved CPAP mask) will then be referred to the BIDMC Specialties Clinic and screened, including review of the medical history of OSA, review of documented reports of excessive air leak and suboptimal adherence to CPAP, brief physical exam (esp. focusing on the head-and-neck exam) including assessment of the CPAP mask-patient interface, review of the purpose and goals of the pilot clinical study, a dynamic video of the study subject face will be performed, video downloaded to a computer which will then be used to generate a 3-dimensional plastic model of the study subject face using state-of-the-art 3D printer technology (see details below). The patient's FDA-approved CPAP mask will then be applied to his plastic model of the study subject face, and the CPAP mask modified with the application of silicon pads along the mask pillow cushion to optimize the CPAP mask-face model interface, primarily by adjustments to improve CPAP mask contact with the face model and limit the air leak during CPAP ventilation.
Once the patient's FDA-approved CPAP mask has been modified, the patient will then return to the BIDMC Specialties Clinic for a final fitting of the modified CPAP mask, with additional adjustments (as necessary) made to optimize the CPAP mask-patient interface. The study subject will then return home with his/her custom-modified CPAP mask to use as prescribed. Standard home monitoring and recording of use of the modified CPAP mask will be performed per usual case over a 30-day period. Data obtained during this 30-day period will focus on the duration of use of the modified CPAP mask, measurement of air leak and pressure loss, report of patient comfort and experience with the modified CPAP mask, and compare to data over a 30 day period using the CPAP mask prior to modification.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of obstructive sleep apnea prescribed CPAP
- High air leak:1. Absolute high leak duration more than 15% of the use period and / or 2. Absolute high leak over 5% associated with periodic breathing.
Exclusion Criteria:
- Unable to wear full face CPAP
- Unable to provide informed consent
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 |
---|---|
Experimental: Modified CPAP
Single arm cohort study of modified mask
|
Modified CPAP mask based on 3D image capture
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Air leak time
Periodo de tiempo: 30 day
|
Percent of air leak time over use of mask
|
30 day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
CPAP mask leak volume
Periodo de tiempo: 30 day
|
Volume of leak recorded on CPAP machine
|
30 day
|
Epworth Sleepiness Scale
Periodo de tiempo: 30 day
|
Sleepiness score - Likelihood of falling asleep in various daytime activities.
Total Score Range 0-24.
|
30 day
|
Apnea Hypopnea Index
Periodo de tiempo: 30 day
|
Apnea Hypopnea Index (events/hour)
|
30 day
|
CPAP Inspiratory pressure
Periodo de tiempo: 30 day
|
Inspiratory pressure setting on CPAP machine (cm H2O)
|
30 day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chee ChunMin, MD, Beth Israel Deaconess Medical Center
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018P000100
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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