Pathophysiology Consequences of Obstructive Sleep Apnea in Biomarkers of Alzheimer's Disease. A Clinical Trial
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 β-amyloid 40 (Aβ-40 and/or Aβ42) concentration
研究概览
简要总结
Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To compare biomarkers of Alzheimer's disease in plasma samples from patients with Obstructive sleep apnea (OSA) and without OSA. 2) To determine if CPAP reduces biomarkers of Alzheimer's disease in plasma samples.
详细描述
Randomized, parallel group, non-blinded, controlled clinical trial compared with conventional treatment.
A. Protocol and intervention Patients with an Apnea-Hypopnea index (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 were used (PLoS ONE 2019;14(9): e0221255). In this case, in order to compare the effect of CPAP it would be necessary to randomize a total of 100 patients with OSA and 30 control subjects.
C. Ethical considerations
- Indication of CPAP treatment for the prevention of Alzheimer's disease is not yet accepted.
- Those patients with an 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/h
- •Controls: subjects with AHI < 5/h and Epworth <10
排除标准
- •Epworth>18
- •BMI<40Kg/M2
- •Arterial Hypertension
- •Diabetes Mellitus
- •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 systemic corticosteroids.
- •Pretreatment with CPAP.
- •Participation in another clinical trial thirty days prior to randomization
- •Abnormal values of a cognitive test.
结局指标
主要结局
Change from baseline in β-amyloid 40 (Aβ-40 and/or Aβ42) concentration
时间窗: 4 months
To compare the change in Aβ-40 and/or Aβ42 levels between the patients allocated to CPAP group and the control group
β-amyloid 40 (Aβ-40 and and/or Aβ42) concentration in OSA and in non-OSA patients
时间窗: Baseline
To compare Aβ-40 and/or Aβ42 levels between OSA and non-OSA patients
次要结局
- Microbiota population color maps from stool and nasopharyngeal samples in OSA and in non-OSA patients(Baseline)
- Phospho-Tau (P-Tau) concentration in OSA and in non-OSA patients(Baseline)
- Apolipoprotein E (APOE) concentration in OSA and in non-OSA patients(Baseline)
- Neurofilament light chain (NfL) concentration 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 abundance from stool and nasopharyngeal samples in OSA and in non-OSA patients(Baseline)
- Associations of microbiota population diversity from stool and nasopharyngeal samples in OSA with biomarkers of Alzheimer's Disease(Baseline)
- Associations of microbiota population abundance from stool and nasopharyngeal samples in OSA with biomarkers of Alzheimer's Disease(Baseline)
- Associations of microbiota population color maps from stool and nasopharyngeal samples in OSA with biomarkers of Alzheimer's Disease(Baseline)
- To evaluate the relationship of biomarkers of Alzheimer's disease and oropharyngeal and gut microbiota with the main classical markers of OSA and nocturnal hypoxic burden.(Baseline)
- Associations between CPAP effects on oropharyngeal and gut microbiota, and biomarkers of Alzheimer's disease.(4 months)
- Change from baseline in biomarkers of Alzheimer's disease, and oropharyngeal and gut microbiota samples of patients with OSA according to the baseline hypoxic burden level and residual hypoxia.(4 months)
- To determine the relationship between compliance with CPAP treatment and the response on biomarkers of Alzheimer's disease and oropharyngeal and gut microbiota.(4 months)
研究者
Alberto Alonso Fernandez
Principal investigator
Fundació d'investigació Sanitària de les Illes Balears