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Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients

28 de abril de 2014 actualizado por: Chinese Pulmonary Vascular Disease Research Group

Long-term Effects of Continuous Positive Airway Pressure on Lipidemia and High-sensitivity C-reactive Protein Levels in Nonobese Patients With Coronary Heart Disease and Obstructive Sleep Apnea

The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and systemic inflammation. The relationship regarding obstructive sleep apnea (OSA) and lipidemia and systemic inflammation is far from conclusion for obesity as a strong confounding factor.

Descripción general del estudio

Descripción detallada

Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep, resulting in sleep fragmentation and oxyhemoglobin desaturation. OSA is recognized as an important public health problem in developed country, affecting 9 and 24% of middle-aged females and males, respectively. OSA, however, is not recognized as an abnormality for the majority and doesn't get more attention from most people in China. Increasing evidence now indicates that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke. Atherosclerosis is a key mechanism for these cardiovascular events. Numerous studies have explored the relationship between hypertension and OSA. And these studies confirms that OSA is an important identifiable cause of hypertension and a raised blood pressure has been shown to fall with effective continuous positive airway pressure (CPAP) treatment. Dyslipidemia, an established independent risk factor for coronary heart disease (CHD) and atherosclerosis, is common in patients with OSA. But there are limited interventional data on OSA and lipidemia, showing controversial results. Several studies9,10 have shown a direct relationship between OSA and lipid profiles, independently of obesity, while other studies have demonstrated that obesity, as a confounding factor, contributed to dyslipidemia among OSA patients.11,12 Taken together, adiposity is a strong confounding factor for interpretation of the causal relationship between dyslipidemia and OSA. Few studies have focused on nonobese patients.10,13 There are only a small number of randomized trials that have examined the effect of CPAP on fasting lipid profiles14,15 and none were specifically designed to evaluate the lipid profiles. Furthermore, most studies assessed the impact of CPAP on OSA-related lipids without statin therapy. In this way, it may be useful to avoid the disturb conditions due to statin treatment. But it is impractical to those patients with OSA and CHD. Since statins, in addition to decreasing hyperlipidemia levels, also inhibit inflammatory cytokines and play a critical role of plaque stabilization in CHD patients. Similarly, the condition existed in the examination of high-sensitivity C-reactive protein (hs-CRP) in CHD subjects with OSA. Therefore, the aims of the present study were (1) to establish whether CPAP therapy decreases lipid profiles and hs-CRP levels in nonobese patients with CHD and OSA, (2) to establish whether a relationship exists between the severity of OSA and levels of these circulating markers, and (3) to demonstrate a possible mechanism for the prevention of cardiovascular disease.

Tipo de estudio

Intervencionista

Inscripción (Actual)

78

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Beijing, Porcelana, 100037
        • Center of pulmonary vascular disease, Fuwai hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Participants diagnosed with a confirmation of CHD and moderate to severe

Exclusion Criteria:

  • A body mass index (BMI) ≥ 25 kg/m2
  • Established hypertension, diabetes mellitus, predominantly central sleep apnea, hypothyroidism
  • A history of smoking, chronic obstructive pulmonary disease, atopy, rhinitis, arthritis
  • Pharmacological treatment that could affect lipids and hs-CRP levels
  • Epworth Sleepiness Scale (ESS) ≥15
  • Diagnosed with malignant cancer with a life expectancy of less than 1 years
  • Severe psychiatric disease, sustained excessive alcohol use, New York Heart Association Class III-IV degree
  • Declined to participate or were unable to give informed consent.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cpap
CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night, according to a previous validation by our study.
Otros nombres:
  • Continuous Positive Airway Pressure(CPAP)
Sin intervención: No Cpap

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
lipid profiles
Periodo de tiempo: baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
plasma fasting lipid profiles were measured at baseline, 6months,and 12months.
baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
High-sensitivity C-reactive protein
Periodo de tiempo: baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months
Fasting plasma high-sensitivity C-reactive protein was analyzed at baseline,6 months,and 12 months.
baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2010

Finalización primaria (Actual)

1 de diciembre de 2013

Finalización del estudio (Actual)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2014

Publicado por primera vez (Estimar)

30 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de abril de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

28 de abril de 2014

Última verificación

1 de abril de 2014

Más información

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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