Intermitent Hypoxia and Its Pathophysiology Consequences in the Sleep Apnea-Hypopnea Syndrome. Basic, Clinical and Therapeutically Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Change from baseline in 8 isoprostane levels
研究概览
简要总结
Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To assess the total or partial recovery of oxidative and inflammatory damage after recovering IH. 2) To check whether the results obtained in vitro on the recovery of the damage according to the form of manifestation of IH are validated in SAHS patients. 3) To determine if CPAP reduces nighttime blood pressure and arterial stiffness depending on whether or not patients have a non-dipping pattern of blood pressure and depending on the degree of correction of IH. 4) To clarify whether residual nocturnal hypoxemia influences the recovery of oxidative and inflammatory damage in patients. 5) To determine nasal and intestinal microbioma and the effect of CPAP treatment
详细描述
Design: Randomized, parallel group, non-blinded, controlled clinical trial compared with conventional treatment.
A. Protocol and intervention Patients with an AHI>30 h-1 will be assigned, using a 1:1 randomization table, to lifestyle recommendations treatment or to lifestyle recommendations plus nasal CPAP, for a period of 4 months. CPAP pressure will be titled with automatic using an AutoSet II device, ResMed.
B. Sample size For the estimation of the sample size, previous data from our group were used. In this case, in order to compare the effect of CPAP in a subgroup of patients with well-controlled OSA and in another with residual hypoxemia; it would be necessary to randomize a total of 85 patients with OSA.
C. Ethical considerations
- Indication of CPAP treatment for the prevention of cardiovascular morbidity and mortality in OSA patients without daytime sleepiness is not yet accepted.
- Those patients with a urgent study indication for the diagnosis and treatment of respiratory sleep disorders (professional drivers, respiratory failure or risk professions) will be excluded from the project. In the other cases, the delay in healthcare for the performance of Polysomnography and CPAP titration exceeds the duration of the study, therefore that patients assigned to the control arm (conventional treatment) will not be exposed to a higher risk than the general population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases: patients with AHI > 30
- •Controls: subjects with AHI < 5 and Epworth >10
排除标准
- •Epworth>18
- •BMI<40Kg/M2
- •Arterial Hypertension
- •Mellitus Diabetes
- •Cerebrovascular disease
- •Ischemic heart disease
- •Cardiac arrhythmia
- •Chronic cardiovascular diseases
- •Daytime Oxygen saturation>95%
- •Risk professions (professional drivers)
- •Concomitant treatment with antihypertensives, statins, antidiabetics, beta-blockers or systemics corticosteroids.
- •Pretreatment with CPAP.
- •Participation in another clinical trial thirty days prior to randomization
结局指标
主要结局
Change from baseline in 8 isoprostane levels
时间窗: 4 months
To compare the change in 8 isoprostane levels between the patients allocated to CPAP group and the control group
Change from baseline in microbiota population diversity from stool samples
时间窗: 4 months
To compare the change in in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group
Change from baseline in microbiota population diversity from nasopharyngeal samples
时间窗: 4 months
To compare the change in microbiota population diversity, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group
Change from baseline in microbiota population abundance from stool samples
时间窗: 4 months
To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group
Change from baseline in microbiota population abundance from nasopharyngeal samples
时间窗: 4 months
To compare the change in microbiota population abundance, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group
Change from baseline in microbiota population color maps from stool samples
时间窗: 4 months
To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from stool samples between the patients allocated to CPAP group and the control group
Change from baseline in microbiota color maps from nasopharyngeal samples
时间窗: 4 months
To compare the change in microbiota population color maps, after massive sequencing and amplification of the 16S rRNA gene from nasopharyngeal samples between the patients allocated to CPAP group and the control group
次要结局
- Augmentation index (%)(Baseline and 4 months)
- Pulse wave velocity (m/sec)(Baseline and 4 months)
- Aortic systolic blood pressure central (mmHg)(Baseline and 4 months)
- Diastolic blood pressure central (mmHg)(Baseline and 4 months)
- Subendocardial viability ratio (%)(Baseline and 4 months)
- Central augmentation pressure (mmHg)(Baseline and 4 months)
- Time to reflection (ms)(Baseline and 4 months)
- Peripheral systolic blood pressure (mmHg)(Baseline and 4 months)
- Patients with undiagnosed hypertension(Baseline and 4 months)
- Peripheral diastolic blood pressure (mmHg)(Baseline and 4 months)
- Nocturnal blood pressure dipping(Baseline and 4 months)
- Nocturnal hypertension.(Baseline and 4 months)
- C-reactive protein (CRP)(Baseline and 4 months)
- Homocysteine(Baseline and 4 months)
- Endothelin(Baseline and 4 months)
- 8 isoprostane levels in OSA and in non-OSA patients(Baseline)
- Lipid profile(Baseline and 4 months)
- Circulating inflammatory proteomic profile in OSA(Baseline and 4 months)
- Systemic inflammation.(Baseline and 4 months)
- Intake-regulating hormones.(Baseline and 4 months)
- Change from baseline in number of patients with desaturation index >3%(4 months)
- Microbiota population abundance from stool and nasopharyngeal samples in OSA and in non-OSA patients(Baseline)
- Microbiota population diversity from stool and nasopharyngeal samples in OSA and in non-OSA patients(Baseline)
- Microbiota population color maps from stool and nasopharyngeal samples in OSA and in non-OSA patients(Baseline)
- Relationships of microbiota population diversity from stool and nasopharyngeal samples in OSA to blood pressure profile.(Baseline and 4 months)
- Relationships of microbiota population abundance from stool and nasopharyngeal samples in OSA to blood pressure profile(Baseline and 4 months)
- Relationships of microbiota population color maps from stool and nasopharyngeal samples in OSA to blood pressure profile(Baseline and 4 months)
- Relationships of microbiota population diversity from stool and nasopharyngeal samples in OSA to augmentation index.(Baseline and 4 months)
- Relationships of microbiota population abundance from stool and nasopharyngeal samples in OSA to augmentation index.(Baseline and 4 months)
- Relationships of microbiota population color maps from stool and nasopharyngeal samples in OSA to augmentation index.(Baseline and 4 months)
- Relationships of microbiota population diversity from stool and nasopharyngeal samples in OSA to pulse wave velocity.(Baseline and 4 months)
- Relationships of microbiota population abundance from stool and nasopharyngeal samples in OSA to pulse wave velocity.(Baseline and 4 months)
- Relationships of microbiota population color maps from stool and nasopharyngeal samples in OSA to pulse wave velocity.(Baseline and 4 months)
研究者
Alberto Alonso Fernandez
Principal investigator
Fundació d'investigació Sanitària de les Illes Balears