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Continuous Monitoring Nocturnal Beat-to-beat Blood Pressure Fluctuation in OSA With or Without Hypertension

28 de marzo de 2017 actualizado por: Xu J, Huai'an No.1 People's Hospital

Huai'an First People's Hospital,Nanjing Medical University

Emerging evidence suggests that there is a causal link between obstructive sleep apnea(OSA) and hypertension. Patient with this syndrome exhibit several characteristics: high prevalence, frequent non-dipper status, diastolic and nocturnal predominance, which are related to clinical and subclinical organ damage in heart and brain. However, the influence of OSA on nocturnal hypertension development has not yet been clarified. Blood pressure variability (BPV) plays a role in vascular damage, independent of blood pressure. Apnea overloads the autonomic cardiovascular control system and may influence BPV,which is classified by different time interval, including beat-to-beat, hour-to-hour day-to-night changes or long-term, for example days, weeks, months, seasons, and even years. All BPV abnormalities are associated with an increased incidence of cardiovascular events and mortality. The investigators pre-experiment estimate BPV by ambulatory blood pressure monitoring (ABPM), which unable to capture the BP fluctuation accurately during the apnea event. The small studies exam beat-to-beat BP and OSA,and the investigators can't couple the events with blood fluctuation, also incapable calculate the correlation of them. This study is aimed to use pulse transmit time(PTT) based blood pressure measurement which can be useful for continuous monitoring of blood pressure to monitor nocturnal beat-to-beat blood pressure fluctuation in OSA with or without hypertension, investigating the degree of relevance between hypoxia, AHI, nocturnal hypertension development and BPV. Besides that the investigators also evaluate the effect of continuous positive airway pressure(CPAP) on blood pressure and nocturnal beat-to-beat BPV.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Methods:

Between March 2016 and December 2016,the investigators initially recruited 450 individuals reporting severe habitual snoring. Primal evaluations including office blood pressure, Epworth Sleepiness Scale Score(ESS), antihypertensive medicine demographic and anthropometric data. Then overnight polysomnography were performed. Of them,100 were severe OSA (AHI>30 episode/h) with hypertension, who were agreed to stop taking antihypertensive medicine. The investigators calculated the time to stop based on the half-life of patients taking oral drugs and last time administration time. The subject who withdrawal time was less than three days was enrolled in this study. These patients were hospitalized and close monitoring of blood pressure, for blood pressure three times greater than 180/110mmHg or appearing dizziness, headache and other clinical syndrome, the investigators will give a timely clinical intervention and get rid of this study. The control group consisted of 100 subjects just with severe OSA whose blood pressure is normal. The investigators recorded nocturnal blood pressure, oximetry, beat-to-beat BPV, AHI, BP event was calculated. Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood pressure control, the investigators would give one-night continuous positive airway pressure(CPAP) to compare the AHI, the mean nocturnal systolic blood pressure and diastolic blood pressure, the number of blood events before and after short-term CPAP therapy, to compare the AHI, the mean nocturnal systolic blood pressure and diastolic blood pressure, the number of blood events before and after short-term CPAP therapy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

198

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

    • Jiangsu
      • Huai'an, Jiangsu, Porcelana, 223300
        • Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University

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

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • severity OSA (AHI>30 episode/h)
  • aged between 18 to 70 yeas
  • blood pressure≦180/110mmHg

Exclusion Criteria:

  • blood pressure>180/110mmHg
  • severe clinical events such as coronary artery disease, heart failure,cerebrovascular disease or renal failure
  • diabetes
  • patients with suspected secondary hypertension
  • patients with pulmonary disease being treated with bronchodilators, corticosteroids, or oxygen
  • individuals who are able to perform the test

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: OSA group
100 severe OSA patients without hypertension were enrolled. Primal evaluations including office blood pressure, Epworth sleepiness scale score(ESS),demographic and anthropometric data The full night polysomnogram was performed, recording nocturnal blood pressure, oximetry, beat-to-beat BPV, AHI, BP event was calculated
Otro: OSA with hypertension
100 severe OSA patients with hypertension were enrolled. Primal evaluations including office blood pressure, Epworth sleepiness scale score(ESS), antihypertensive medicine demographic and anthropometric data. The full night polysomnogram was performed, recording nocturnal blood pressure, oximetry, beat-to-beat BPV, AHI, BP event was calculated.Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood pressure control, the investigators would give one-night CPAP.
OSA complicated with hypertension:In order to avoid the effects of drugs on this study, we calculated the time to stop based on the half-life of patients taking oral drugs and last time administration time. The subject who withdrawal time was less than three days was enrolled in our study. These patients were hospitalized and close monitoring of blood pressure, for blood pressure three times greater than 180/110mmHg or appearing dizziness, headache and other clinical syndrome, we give a timely clinical intervention and get rid of our study. Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood control,the investigators would give one-night CPAP

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Office hypertension
Periodo de tiempo: 2 hours
as BP≧140/90mmHg on three different occasions (according to standard guidelines)
2 hours
nocturnal hypertension
Periodo de tiempo: 1 night

as nighttime systolic blood pressure

≧120mmHg and/or70mmHg(diastolic blood pressure)

1 night
hypoxemia
Periodo de tiempo: 1 night
as the total time and the number of pulse oxygen less than 90% ,the minimum lowest pulse oxygen saturation during sleep
1 night
Beat-to-Beat BPV
Periodo de tiempo: 1 night
as the a increase in systolic blood pressure(SPB) from baseline during an apnea event
1 night
BP event
Periodo de tiempo: 1 night
the number of beat-to-beat BPV>10mmHg divided by sleep time
1 night
Apnea-hypopnea index(AHI)
Periodo de tiempo: 1 night
AHI was defined as the number of apnea plus hypopnea episode per hour of sleep and was the summary measurement of the occurrence of sleep -disordered breathing.Apnea was defined as a reduction of airflow of at least 90% on the oronasal thermistor for at least 10s(it was considered obstructive if respiratory effort was absent).Hypopneas was scored when the magnitude of the signal decreased by at least 30% of the baseline amplitude of the nasal pressure transducer for at least 10s and was associated with a 4% or greater drop in oxygen saturation,as measured by finger pulse oximetry.
1 night
time of event
Periodo de tiempo: 1 night
as the total time of apnea and hypopnea during sleep
1 night

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Zi Li Meng, Master, Huai'an First People's Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 marzo de 2016

Finalización primaria (Actual)

27 de marzo de 2017

Finalización del estudio (Actual)

27 de marzo de 2017

Fechas de registro del estudio

Enviado por primera vez

10 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

22 de agosto de 2016

Publicado por primera vez (Estimar)

23 de agosto de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de marzo de 2017

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

28 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Huaian1PH

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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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