Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 9
- 主要终点
- Increase in ventilation (L/min) from baseline
研究概览
简要总结
Obstructive sleep apnea (OSA) is inherently site-specific. In a physiological controlled intervention study, the investigators seek to determine whether applying expiratory resistance can acutely improve ventilation and sleep in patients with expiratory flow limitation (EFL).
详细描述
Collapse of the upper airway can occur at different sites of the pharynx. One common and recognizable form of pharyngeal collapse is prolapse of the soft palate (velopharynx) on expiration, a phenomenon referred to as expiratory flow limitation (EFL). In principle, application of nasal positive expiratory pressure should reverse expiratory narrowing, increase ventilation, and prevent the subsequent progressive loss of airflow that leads to arousal from sleep, thereby improving OSA. One means to achieve this expiratory pressure is with the use of an added nasal expiratory resistance.
Accordingly, during a single night protocol, the investigators will examine the effects of increasing nasal expiratory resistance during sleep. During obstructed breathing, patients will be switched acutely, in random order, from normal conditions to an added expiratory resistance (30-80 cmH2O/L.s) or a sham resistance, for short (1 min) and prolonged periods (1 hour), repeatedly overnight.
Patients participating in the study will be divided into two groups, those exhibiting EFL versus those without EFL (i.e. with inspiratory flow limitation).
The main outcomes of the short physiologic interventions are:
- Increase in ventilation, and
- Increased time to a respiratory-related arousal from sleep, relative to sham conditions.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of obstructive sleep apnea (AHI>10/hr)
排除标准
- •Serious co-morbidities including lung disease, heart disease, renal disease
- •Medications affecting respiration or sleep
- •Expiratory flow limitation (EFL) subgroup inclusion criteria: presence of clear EFL on polysomnographic study (reduced flow and increased pharyngeal pressure during expiration as a predominant cause of airflow obstruction).
- •non-EFL subgroup inclusion criteria: complete absence of EFL on polysomnographic study
研究组 & 干预措施
Expiratory resistance
Generic expiratory resistance will be added to the patient's respiratory circuit
干预措施: Expiratory resistance (Device)
Sham expiratory resistance
Sham resistance will be added to the patient's respiratory circuit
干预措施: Sham expiratory resistance (Device)
结局指标
主要结局
Increase in ventilation (L/min) from baseline
时间窗: Acutely (1 min)
次要结局
- Increase in time to arousal from sleep(Acutely (1 min))
- Reduction in frequency of respiratory events (apnea-hypopnea index, 3% desat/arousal; NREM supine)(Acutely (1 hour))
研究者
David Andrew Wellman
Associate Professor
Brigham and Women's Hospital