Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Cardiovascular outcome: interventricular septum thickness
研究概览
简要总结
The goal of this prospective study is to gain insight into the endophenotypic variation in OSA, with a focus on the underlying pathophysiological traits and the cardiovascular alterations associated with the condition. To capture the variability in OSA endophenotypes, novel metrics that extend beyond the AHI will be considered, with particular attention to the sleep-apnea-specific hypoxic burden, the sleep-apnea-specific heart rate response, and pulse wave amplitude drops (PWADs). Since the impact of treatment on cardiovascular parameters remains an important point of interest, the effects of different treatment modalities on cardiovascular changes will be investigated, including continuous positive airway pressure (CPAP), mandibular advancement devices (MADs), and hypoglossal nerve stimulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •AHI ≥ 15 events/hour, based on a recent (<2 years) PSG, conducted in Antwerp University Hospital
- •Patients must be 18 years or older
- •Patients must be dutch-speaking
- •Patients must be eligible for their therapy (CPAP, MAD or HNS)
- •Willing to participate after informed consent
排除标准
- •Central apneas accounting for ≥25% of total apneas during baseline polysomnography
- •Patients who have received effective CPAP therapy (defined as CPAP use for ≥4 h/night) within the previous 6 months
- •Patients with prior MAD therapy
- •Uncontrolled hypertension
- •Known cardiomyopathy
- •Significant coronary arterial disease
- •Clinically significant valvular heart disease, defined as more than mild left-sided valvular disease or more than moderate right-sided valvular disease
- •Congenital heart disease
- •Participants may be excluded if, after rescoring, outcome measures do not meet predefined criteria
结局指标
主要结局
Cardiovascular outcome: interventricular septum thickness
时间窗: 1 year
Interventricular septal thickness will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
Cardiovascular outcome: left ventricular ejection fraction
时间窗: 1 year
Left ventricular ejection fraction will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.
Sleep apnea-specific hypoxic burden (SASHB)
时间窗: 1 year
This novel metric is calculated by determining the total area under the respiratory event-related desaturation curve, which can be obtained from a polysomnography (PSG). It has been shown to be a good predictor of cardiovascular disease mortality, but has not yet been established in daily practice.
Cardiovascular outcome: heart rate variability
时间窗: 1 year
Heart rate variability will be calculated from ECG-derived RR intervals obtained during the sleep study.
OSA efficacy: delta apnea-hypopnea index (AHI)
时间窗: 1 year
The apnea-hypopnea Index (AHI), defined as the number of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep measured during a polysomnography, will be assessed. OSA is diagnosed when the AHI is at least 5/h. The AHI classifies OSA as mild with AHI ranging from 5 to 14.9 events per hour, moderate with AHI ranging from 15 to 29.9 events per hour and severe when 30 or higher events per hour.
次要结局
- Sleep apnea-specific hypoxic burden (SASHB)(1 year)
- Cardiovascular outcome: heart rate variability(1 year)
- Cardiovascular outcome: left ventricular ejection fraction(1 year)
- Cardiovascular outcome: left ventricular mass(1 year)
- OSA efficacy: delta apnea-hypopnea index (AHI)(1 year)
- Oxygen desaturation index (ODI)(1 year)
- Heart rate response to a respiratory event (ΔHR)(1 year)
- Pulse wave amplitude drops (PWADs)(1 year)
- Cardiovascular outcome: 24-hour ambulatory blood pressure(1 year)
- Cardiovascular outcome: systolic and diastolic function(1 year)
- Therapy adherence defined by the amount of hours of therapy usage per night and the number of nights per week of use(1 year)
- Degree of snoring measured by Visual Analogue Scale (VAS)(1 year)
- Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire(1 year)
- Fatigue measured by the Checklist Individual Strength (CIS) questionnaire(1 year)