- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03300700
Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea
Descripción general del estudio
Estado
Condiciones
Descripción detallada
American Sleep Apnea Association considers exercise as a non-pharmacological treatment modality of sleep disorders . Theoretical reviews and hypotheses on the effects of exercise in OSA have suggested thermoregulatory, metabolic, and biochemical mechanisms although clinical trials on the topic are inadequate .
Cardiopulmonary exercise testing (CPET) is used as a stress test to evaluate cardiac, pulmonary, and muscle function. It has also been used to differentiate whether the etiology of impairment of the ca. rdiopulmonary exercise test is cardiac, pulmonary or muscle dysfunction In otherwise healthy subjects, exercise limitation is due to heart disease. Patients with OSAS are frequently overweight and may exhibit lung function abnormalities related to their weight. These include a decrease in the functional residual capacity (FRC) due mainly to a decrease in the expiratory reserve volume (ERV) and a decrease in compliance of the respiratory system. These functional abnormalities cause an increase in the energy cost of breathing. In addition, increased body mass is associated with greater metabolic energy requirements during muscular exercise, resulting in further ventilatory stress. There are reports demonstrating that there are discriminating measurements during exercise in obesity, including a high O2 cost to perform external work, and upward displacement of the VO2 -WR relationship OSAS patients have daytime hypersomnolence, decreased daily activity and tissue hypoxemia which may further impair muscle function and decrease exercise fitness. Recently, Peppard and Young (2004) found that, independent of body habitus, lack of exercise was associated with increased severity of sleep-disordered breathing measurements during exercise in obesity, including a high O2 cost to perform external work, and upward displacement of the VO2 -WR relationship. OSAS patients have daytime hypersomnolence, decreased daily activity and tissue hypoxemia which may further impair muscle function and decrease exercise fitness. Recently, Peppard and Young (2004) found that, independent of body habitus, lack of exercise was associated with increased severity of sleep-disordered breathing
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Assiut, Egipto, Assiut,Egypt,Assiut university
- Assiut university hospital
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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
Descripción
Inclusion Criteria:
- Stable OSA patients
Exclusion Criteria:
- Cardiovascular diseases .
- Orthopedic or neurological conditions affecting the ability of exercise.
- Patients with previous lung resection or malignancies.
- Patients with liver cell failure, renal failure.
- Muscloskeletal disease.
- Other chronic chest disease eg, ILD.
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 |
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Ventilatory parameters of cardiopulmonary exercise test
Periodo de tiempo: 30 minutes
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End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea
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30 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Raafat T El-Sokkary, prof, Assiut University
Publicaciones y enlaces útiles
Publicaciones Generales
- Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
- Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. doi: 10.1378/chest.103.5.1336.
- McNamara SG, Grunstein RR, Sullivan CE. Obstructive sleep apnoea. Thorax. 1993 Jul;48(7):754-64. doi: 10.1136/thx.48.7.754. No abstract available.
- Ozturk L, Metin G, Cuhadaroglu C, Utkusavas A, Tutluoglu B. FEF(25-75)/FVC measurements and extrathoracic airway obstruction in obstructive sleep apnea patients. Sleep Breath. 2005 Mar;9(1):33-8. doi: 10.1007/s11325-005-0006-1.
- Vgontzas AN, Bixler EO, Chrousos GP. Sleep apnea is a manifestation of the metabolic syndrome. Sleep Med Rev. 2005 Jun;9(3):211-24. doi: 10.1016/j.smrv.2005.01.006.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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
- CETIPWOSA
Plan de datos de participantes individuales (IPD)
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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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