Arterial Stiffness and Blood Pressure Changes After Continuous Positive Airway Pressure (CPAP) Withdrawal for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Arterial stiffness.
研究概览
简要总结
Background: Patients with obstructive sleep apnea run an increased risk of cardiovascular disease including hypertension. Continuous positive airway pressure (CPAP) is the first line of treatment. However, many patients skip CPAP for some nights.
Aims: The primary aim was to investigate the cardiovascular effects of short-term CPAP withdrawal for five nights because of obstructive sleep apnea.
Design: Randomized, parallel controlled trial Inclusion criteria: 100 patients with successful CPAP treatment for moderate to severe obstructive sleep apnea.
Exclusion criteria: Dementia, heart infarction within 3 months, apnea hypopnea index > 10 with CPAP treatment.
Randomization: 50 patients are randomized to sleep 5 days without CPAP and 50 patients to continue with CPAP treatment during the trial.
Primary outcomes: Arterial stiffness, 24-hour blood pressure. Secondary outcomes: Effects of gender on outcome. Effects on brain natriuretic peptide, apnea-hypopnea index, oxygen desaturation-index, urine-catecholamines, blood lipids, C-reactive protein, glucose metabolism (S-glc, HBA1c), insulin resistance, serum creatinine, hemoglobin, daytime sleepiness (ESS, KSS), lung function (FVC, FEV1), airway inflammation (exhaled NO) Procedures: Sleep apnea investigation while patients are treated with CPAP for one night. Urinary samplings during the same night. They are also investigated with 24 h blood pressure measurements. Blood samples are taking fasting in the morning followed by measuring the arterial stiffness (Vicorder, Skidmore Medical UK) including pulse wave analysis using sphygmomanometer (Omron Japan). The same investigations are done at follow-up 5 days later where half of the patients have continued using CPAP treatment and half of them has slept without CPAP.
详细描述
Patients fulfilling inclusion criteria are invited to the trial after informed consent for baseline and follow-up investigations.
Baseline investigations Day 1 Patients are given a questionnaire. They are given blood pressure monitoring, (ABPM Medical 90217 ambulatory blood pressure monitor, Spacelab) for 24 hours a starting at 8-9 AM. They are also given sleep apnea recorder (Embletta, X 10 system, Embla systems, ResMed) for ambulatory use during the following night, and a container for urinary sampling during the night (urine norepinephrine).
Day 2 Fasting on arrival. Return of the 24-h blood pressure recorder, the sleep apnea recorder and the urine sampling container.
Blood samples at 08.15 am after resting for 15 minutes. Arterial stiffness is measured using arterial pulse wave velocity, radial artery applanation tonometry and office blood pressure. After resting, the measurements starts at 8.30 AM in a room with a temperature of 24°C. Pulse wave velocity (Vicorder, Skidmore Medical, Bristol, UK) is measured in the supine position. The augmentation index is derived from pulse wave analysis obtained from radial artery applanation tonometry on the right arm (SphygmoCor, AtCor Medical, Sydney, Australia).
Lung function and exhaled NO measurements, ECG. Breakfast at around 10.00 am. CPAP time counter check Patients are then randomized with a ration of 1:1 to continue with CPAP or not for the following 5 nights.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older,
- •given the written consent to participate in the study,
- •2 months to 2 years of continuous positive airway pressure (CPAP) treatments with good compliance (mean CPAP use of >4 hours/night) during the last month before inclusion
- •moderate sleep apnea with Apnea Hypopnea Index >15 before treatment
排除标准
- •Apnea hypopnea index > 10 with CPAP treatment,
- •heart infarction within 3 months prior to study participation,
- •severe dementia,
- •determined by study personal having psychological or physical hinder to participate in the study
结局指标
主要结局
Arterial stiffness.
时间窗: 5 days
Arterial stiffness measured with Vicorder and pulse wave analysis
Systolic and diastolic blood pressure
时间窗: 5 days
24 hour blood pressure measurements
次要结局
- Effect on oxygen saturation(5 days)
- Impact on apnea hypopnea index(5 days)
- Effect on myocardial function(5 days)
- Effect on systemic inflammation.(5 days)
- Assessment of daytime sleepiness for a past period of time(5 days)
- Daytime sleepiness assessed at a certain time point(5 days)
- Gender differences(5 days)
- Long-term effect on glucose metabolism(5 days)
- Effect on lung volumes(5 days)
- Effect on airway obstructions(5 days)
- Effect on catecholamines(5 days)
- Effect on blood lipids in the form triglycerides(5 days)
- Effect on renal function(5 days)
- Effect on blood lipids in the form of cholesterol(5 days)
- Effect on glucose metabolism in the form of fasting glucose(5 days)
- Glucose metabolism in the form om Insulin levels(5 days)
- Effect on hemoglobin(5 days)
- Effect on airway inflammation(5 days)