Effect of Servo-Ventilation on CO2 Regulation and Heart Rate Variability
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Respiratory Rate
研究概览
简要总结
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a condition where the upper airway partially collapses and closes. This can lead to sleep problems including low oxygen levels, poor sleep, elevated carbon dioxide levels in the blood, and activation of the sympathetic nervous system. Results from having disrupted sleep may be excessive daytime sleepiness along with behavioral, functional, cardiovascular and cognitive dysfunction. Continuous Positive Airway Pressure (CPAP) is the most effective treatment for OSAHS. CPAP stabilizes the airway and prevents instability and collapse. Other forms of positive airway pressure that are approved for the treatment of OSAHS include automatically adjusting CPAP, Bi-level Positive Airway Pressure (BiPAP), and automatically adjusting BiPAP. Automatically adjusting CPAP (Auto CPAP) evaluates the airflow pattern and adjusts pressure to optimize airflow. AutoSV (Auto Servo Ventilation) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea.
In the prior study, the investigators found that the Auto S7 device led to more positive ventilation outcomes. Specifically, there was prolongation of QTc interval (the calculated time from the Q wave to the end of the T wave) and a tendency for greater premature ventricular contractions. The mechanistic basis for this could be attributable to excessive ventilation and related pro-arrhythmic effects of hypocapnia, though the investigators had not performed measures (partial pressure of CO2 (PaCO2) to detect this.
In the current study, the investigators would like to investigate the hypothesis that the S7 device leads to lower PaCO2 levels than other devices, and whether these effects are augmented in individuals with complex sleep apnea in the setting of systolic heart failure.
详细描述
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a condition characterized by intermittent partial collapse and closure of the upper airway (UA). This leads to sleep fragmentation, oxygen desaturation, hypercarbia, and activation of the sympathetic nervous system. OSAHS is also associated with excessive daytime sleepiness, as well as other behavioral, functional, cardiovascular and cognitive dysfunction.
Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the OSAHS. CPAP stabilizes the airway and prevents instability and collapse. With a stable airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing.
CPAP is applied to the upper airway via a mask that covers the nose or the nose and mouth and reduces/eliminates sleep disordered breathing. The period of maximum susceptibility to airway collapse is at the end of exhalation and during early inhalation. During inhalation, negative pressures are generated in the airway by the normal process of ventilation (increase of thoracic volume and reduction of intra-thoracic pressure). The constant pressure of CPAP supports the airway throughout the ventilatory cycle.
In the sleep laboratory, titration of positive airway pressure is performed to determine effective CPAP pressures. During the procedure, the patient is instrumented for full polysomnography (PSG). Therapy is applied and pressure is adjusted during the course of the night to stabilize the upper airway and the breathing pattern. With conventional CPAP, a single pressure level is applied to the airway. While adequate for a majority of patients with obstructive sleep apnea, this static prescription will present challenges in certain patients and conditions.
Other forms of positive airway pressure that are approved for the treatment of OSAHS include automatically adjusting CPAP (Auto CPAP), Bi-level Positive Airway Pressure (BiPAP), and automatically adjusting BiPAP. Auto CPAP evaluates the airflow pattern and adjusts pressure to optimize airflow. Auto CPAP accommodates patients presenting with highly variable pressure requirements (e.g., sleep stage or body position dependent sleep apnea). The automatic adjustment can be used in patients for whom in-laboratory therapy titration is either delayed or impossible.
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
盲法说明
There will be no masking involved in this study.
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
- •Ability to provide consent
- •Currently prescribed servo ventilation therapy at home
- •At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 10 of 14 nights)
- •Individuals with complex sleep apnea (obstructive sleep apnea with central apneas) and preserved left-ventricular ejection fraction (LVEF > 45%) and/or heart failure with preserved ejection fraction (HFrEF) who are currently on ASV therapy.
- •Individuals with complex sleep apnea (predominantly obstructive sleep apnea with central apneas) and reduced left-ventricular ejection fraction (LVEF < 45%) and/or heart failure with reduced ejection fraction (HFrEF) who are currently on ASV therapy.
排除标准
- •Participants who are acutely ill, medically complicated or who are medically unstable
- •Participants in whom PAP therapy is otherwise medically contraindicated
- •Participants who are claustrophobic
- •Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) AND moderate to severe predominant central sleep apnea
- •Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
- •Participants requiring any kind of oxygen therapy
- •Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days.
研究组 & 干预措施
BiPAP AutoSV Advanced System One
干预措施: BiPAP AutoSV Advanced System One (Device)
Dreamstation BiPAP AutoSV
干预措施: Dreamstation BiPaP AutoSV (Device)
ResMed S7 VPAP Adapt device
干预措施: ResMed S7 VPAP Adapt Device (Device)
结局指标
主要结局
Respiratory Rate
时间窗: Change from Baseline through Day 4
Respiratory Rate is measured by the number of breaths taken per minute. Scores are reported in breaths per minute, and is collected from the ventilation device.
Minute Ventilation
时间窗: Change from Baseline through Day 4
Minute Ventilation is the amount of air the subject moves in one minute. It is a product of the ventilatory rate and tidal volume. Scores are reported in liters per volume, and is collected from the ventilation device.
Tidal Volume
时间窗: Change from Baseline through Day 4
Tidal Volume is the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. Scores are reported in ml/kg, and is collected from the ventilation device.
Acid-Base Status
时间窗: Change from Baseline through Day 4
Acid-base status is utilized to determine if subjects have increased/decreased partial carbon dioxide levels (PCO2), or decreased/increased extracellular base excess or actual Bicarbonate levels (HCO3). This is measured through transcutaneous PCO2 monitoring as well as through venipuncture blood collection. Scores are reported in millimoles per liter (mmol/l).
QTc Intervals
时间窗: Change from Baseline through Day 4
QTC intervals are utilized to assess the time it takes for the heart to go from the start of the Q wave to the end of the T wave, and approximates to the time taken from when the cardiac ventricles start to contract when they finish relaxing. Scores are reported in milliseconds, and is collected from the electrocardiogram.
Electrolyte Status
时间窗: Change from Baseline through Day 4
Electrolytes Sodium (Na), Potassium (K), and Chlorine (CI) is collected through venipuncture blood collection. Scores are reported in millimoles per liter (mmol/l).
次要结局
未报告次要终点