Obstructive Sleep Apnea and Cardiac Electrophysiologic Biomarkers of Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- QT Interval (Corrected) Baseline Visit
研究概览
简要总结
Obstructive sleep apnea (OSA) has been associated with cardiac repolarization abnormalities and implicated in sudden cardiac death. A biologically plausible mechanism by which OSA exerts this lethality is by QT interval prolongation, a known marker of ventricular tachyarrhythmias (VTA) leading to cardiac death. Congenital long QT syndrome (LQTS) is a familial arrhythmogenic disorder characterized by prolonged QT interval on the electrocardiogram and increased propensity for VTA. Preliminary data identify an association of the extent of severity of OSA and progressive prolongation of the corrected QT interval in LQTS.
详细描述
Potential participants will come to the Cleveland Clinic Clinical Research Unit (CRU) for informed consent, eligible participants will undergo a 12 lead electrocardiogram. If the participants is found to have long QT syndrome (QTc ≥ 450 in men ad ≥ 470 in women) the participant will continue on in the study. If the participant is found to not have long QT syndrome the participant will exit the study. If continuing on in the study the participant will undergo a fasting venipuncture and blood pressure measurements. The participant will then be shown how to use the portable sleep study hook-up and continuous 12-lead ECG monitoring to be monitored in the home setting. The sleep study and ECG monitors will be returned by a courier service the next morning.
Those participants who are identified to have OSA (apnea hypopnea index>5, estimate 50% of those recruited) on the portable sleep monitoring will be invited to wear CPAP for 2-3 months with a follow up visit with repeat portable polysomnographic and continuous electrophysiologic assessments and CRU visit for bloodwork and blood pressure.
DATA COLLECTION Portable Polysomnography The Embletta Gold ® is a battery-operated device that can sample data at a 1000 Hz sampling rate and store data at 200 Hz, with 1 GB of storage capacity allowing storage of data from up to 20-24 hrs of recording. The device contains the critical sensors which are recommended by the American Academy of Sleep Medicine as validated sensors for measuring OSA: nasal pressure/flow; thoracic and abdominal inductance plethysmography (effort); and finger pulse oximetry (oxygen saturation).
Relevant PSG Variables: A registered polysomnologist will score the sleep study data. Apneas will be classified as "central" or "obstructive" according to the absence or presence of respiratory effort respectively. Hypopneas will be scored as a 50% amplitude reduction in inductance or flow and associated 3% oxygen desaturation or arousal. Periodic breathing will be defined as airflow or inductance channels increasing and decreasing at least 50% from the maximum, in a cyclic waxing and waning or "sinusoidal" manner for a consecutive period of >10 min.
Continuous Overnight 12-lead ECG Monitoring CardioDay Holter (GE) monitoring reads SEER 12 data and exports Holter data as individual 10 second, 12 lead reports up to six per minute, i.e. all recorded data. The monitor is capable of continuous 12-lead ECG monitoring with the ability to record up to 10 days with Bluetooth ® technology and 12-bit signal resolution with up to 1024 sampling rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of QT prolongation as described above
- •Age 18-75 years
- •Individuals able to participate in at least 2 overnight sleep and hysiologic assessments over a 3 month period.
排除标准
- •Use of specific OSA treatments (CPAP, oral appliances)
- •Use of supplemental oxygen
- •Severe chronic insomnia
- •Circadian rhythm disorder (e.g. shift work sleep disorder, delayed or advanced sleep phase syndrome)
- •Insufficient sleep syndrome defined by reported sleep duration < 4 hours
- •Unstable medical conditions (e.g., new onset or changing angina, a myocardial infarction or congestive heart failure exacerbation documented within the previous 3 months, uncontrolled hypertension (BP>170/110), uncontrolled diabetes mellitus (HbA1c>9.0), uncontrolled hypo- or hyperthyroidism)
- •Psychiatric disorders which are inadequately treated
- •Compromised competence
- •Alcohol abuse (currently drinks >5 alcoholic drinks/day)
- •Inability to provide informed consent
- •Illicit drug use over last 6 months.
- •Rationale for criteria:
- •Patients with sleep disorders will be excluded as other sleep disorders may influence arrhythmogenesis.
- •Those on treatment for SDB will be excluded because treatment would preclude assessment of OSA pathophysiologic effects on QT biomarkers.
- •Those with unstable medical conditions or rapid or uncontrolled heart rate will be excluded due to safety reasons.
结局指标
主要结局
QT Interval (Corrected) Baseline Visit
时间窗: The 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night.
To examine the extent that OSA severity from overnight polysomnograph is associated with corrected QT interval (QTc) from daytime 12-lead ECG. The 24 hour continuous ECG is not available.
QT Interval (Corrected) Follow up Visit
时间窗: The 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night. This will be collected at their follow up visit after wearing CPAP for 2-3 months.
To examine the extent that OSA severity from overnight polysomnograph is associated with corrected QT interval (QTc) from daytime 12-lead ECG. The 24 hour continuous ECG is not available.
次要结局
- Effect of OSA Treatment on QTc(After wearing CPAP for approximately 2-3 month the 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night.)
研究者
Reena Mehra, MD
Director, Sleep Disorders Research, Neurologic Institute
The Cleveland Clinic