Effect of Intervention With Continuous Positive Pressure (CPAP) on Nocturnal Blood Pressure (BP) in Patients With Masked Hypertension and Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Effect of CPAP treatment on BP in masked hypertensive patients with severe OSA
研究概览
简要总结
The general objective is to evaluate the effect of continuous positive airway pressure (CPAP) treatment in patients with masked hypertension.
The secondary objectives are: i) To evaluate the prevalence of different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) (dipper / non-dipper); ii) To assess in these patients the relationship between compliance with CPAP treatment and the response to nocturnal BP; iii) To identify variables of the ABPM, and biomarkers that are related to the unfavourable pattern of nocturnal BP response in these patients treated with CPAP; iv) To evaluate the change in the profile of biomarkers with the treatment.
Methodology: Open, parallel, prospective, randomized and controlled study in which an ABPM will be performed in individuals with masked hypertension referred to the sleep unit and diagnosed of OSA (AHI≥ 30) without sleepiness (Epworth≤18).
A total of 64 subjects with OSA and masked hypertension will be recruited. It will be collected blood for the determination of biomarkers. Subsequently, they will be randomized to receive treatment with CPAP (32) or conservative treatment (32). After 3 months of initiation, ABPM and biological determinations will be repeated.
详细描述
Recruitment: It will be recruited subjects with masked hypertension. For that, normotensive subjects (Blood pressure (BP)<140/90mmHg in the office) referred to the sleep unit of the Hospital Santa Maria (Spain) who are diagnosed of severe OSA (AHI≥30) by a sleep study and who do not present significant somnolence (Epworth≤18) will be proposed to participate in the study. Then, it will be performed an ABPM during-24 hours, and those subjects with an abnormal ABPM results and normal BP in the office will be included, are those subjects called masked hypertensive.
Definition of the groups: Patients will be randomized to receive one of the following treatments:
- CPAP: Patients who will receive CPAP treatment. The CPAP titration will be carried out with an automatic or manual CPAP according to usual clinical practice.
- Conservative treatment: Patients who will receive conservative treatment based on hygienic-dietetic measures.
Randomization: It will be carried out with an automated platform
Duration of the treatment: All patients randomized to CPAP will begin treatment as soon as possible after randomization, and will continue treatment until the study ends (3 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years of age
- •Referred to the sleep unit for suspected OSA
- •Being masked hypertensive and presenting an AHI≥ 30 in the sleep study
- •Signature of the informed consent.
排除标准
- •Previous CPAP treatment
- •Significant somnolence defined by an Epworth Sleepiness Scale (ESS) score higher than 18
- •Psychophysical inability to complete questionnaires
- •Previous diagnosis or suspicion of another sleep disorder
- •Presence of more than 50% of central apneas or Cheyne-Stokes respiration
- •Having a serious chronic disease: neoplasia, renal failure, severe chronic obstructive pulmonary disease, chronic depression and other chronic limiting diseases
- •Medical history that may interfere with the objectives of the study or, in the opinion of the researcher, may compromise the conclusions
- •Any medical, social or geographical factor that may endanger the patient's compliance
- •Having a profession of high risk (professional driver).
结局指标
主要结局
Effect of CPAP treatment on BP in masked hypertensive patients with severe OSA
时间窗: 3 years
Change in mmHg in the blood pressure of the ambulatory blood pressure monitoring parameters after the treatment
次要结局
- Prevalence of the different circadian BP patterns (dipper/no-dipper) in the ABPM of masked hypertensive subjects diagnosed with severe OSA without significant somnolence (Epworth≤18)(3 years)
- Association between CPAP use and blood pressure change in ABPM(3 years)
- Ambulatory blood pressure parameters that could be related to the response to CPAP treatment(3 years)
- Changes in the biomarkers' profile (mRNAs) after CPAP treatment(3 years)
研究者
Ferran Barbe
Head of Pulmonology
Sociedad Española de Neumología y Cirugía Torácica