Effect of Fixed Versus Auto-titrating Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Patients With Resistant Hypertension and Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- 24 hour blood pressure.
研究概览
简要总结
The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA).
The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.
详细描述
The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Resistant Hypertension
- •Moderate Obstructive Sleep Apnea
排除标准
- •Creatinine >150 μmol/l
- •Systolic blood pressure > 170 mmHg
- •Diastolic blood pressure > 105 mmHg
- •Secondary cause of hypertension other than OSA
- •Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder
- •Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications
研究组 & 干预措施
Fixed
Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.
干预措施: CPAP (Device)
auto-titrating
Patients being treated for 6 weeks with auto-titrating continuous airway pressure.
干预措施: APAP (Device)
结局指标
主要结局
24 hour blood pressure.
时间窗: 6 weeks and 12 weeks after initial intervention
次要结局
- Non-invasive measures of arterial stiffness using applanation tonometry.(6 weeks and 12 weeks after initial intervention)
- Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.(6 weeks and 12 weeks after initial intervention)
- Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.(6 weeks and 12 weeks after initial intervention)
研究者
Dr. Stella Daskalopoulou
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre