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临床试验/NCT03869125
NCT03869125已完成不适用

Masked Hypertension Evaluated by Automated Office Blood Pressure Measurement (AOBPM) and Office Blood Pressure Measurement (OBPM) in Patients With Obstructive Sleep Apnoea

University Hospital Olomouc1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
The difference in masked hypertension prevalence between definition I and definition II

研究概览

简要总结

Assessment of the possible difference in masked hypertension prevalence when it is evaluated by automated office blood pressure measurement (AOBPM) instead of office blood pressure measurement (OBPM) in patients with obstructive sleep apnoea.

详细描述

Rationale:

Obstructive sleep apnoea is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation > 50%+ blood oxygen desaturation > 4%). It is considered to be an important risk factor for arterial hypertension. In these patients is highly prevalent nocturnal hypertension (NH) and also masked hypertension (MH). Ambulatory blood pressure monitoring (ABPM) is considered to be a gold standard for the diagnosis of NH and MH. Results of ABPM are compared with office blood pressure measurement which could be falsely elevated in some patients (white coat effect). For this reason, automatic office blood pressure measurement was developed. Nowadays some devices like BpTRU were developed. This was validated on some patient groups but robust data for patients with obstructive sleep apnoea are missing.

Process:

Patient with ronchopathy and suspected obstructive sleep apnoea undergo automated office blood pressure monitoring followed by office blood pressure monitoring at the Department of Exercise Medicine and Cardiovascular Rehabilitation. After education, ambulatory blood pressure monitor will be provided to patients for the following 24 hours. In the same night, respiratory polygraphy will be performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc. All data will be statistically evaluated after completion of the target number of subjects. Patients without obstructive sleep apnoea (apnoea-hypopnoea index < 5) will not be included in statistical evaluations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Obstructive sleep apnoea syndrome

排除标准

  • Non- compliance of patients with blood pressure monitoring

结局指标

主要结局

The difference in masked hypertension prevalence between definition I and definition II

时间窗: 1 day

Masked hypertension- definition I- office blood pressure measurement \< 140/90 mmHg and daytime ambulatory blood pressure measurement \> 135/85 mmHg Masked hypertension- definition II- automated office blood pressure measurement \< 140/90 and daytime ambulatory blood pressure measurement \> 135/85 mmHg

次要结局

未报告次要终点

研究者

发起方
University Hospital Olomouc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Milan Sova

Head of Sleep Laboratory, Department of Respiratory Medicine

University Hospital Olomouc

研究点 (1)

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