Effect of High Flow Nasal Cannula (Flowrest®) on Mild-Moderate Sleep Disordered Breathing: A Non-Inferiority Study Versus Nasal Continuous Positive Airway Pressure (CPAP) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- AHI Change (Therapy v Baseline)
研究概览
简要总结
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
详细描述
Study to evaluate the acute efficacy of a single night of High Flow Therapy (HFT) to treat mild-moderate predominantly obstructive Sleep Disordered Breathing, as compared to nasal Continuous Positive Airway Pressure (CPAP) therapy. Subjects will be order-randomized to receive HFT or CPAP in the laboratory, undergo a washout period, and return for the alternative therapy in the laboratory. The hypothesis is that HFT will be non-inferior to CPAP in controlling Apnea/Hypopnea events in this subject set during this study.
Primary outcome will be Apnea / Hypopnea Index (AHI) change on therapy as compared to baseline diagnostic polysomnography.
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 (Investigator)
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
- •At least 18 years of age
- •Previous diagnosis of primarily obstructive mild-moderate Sleep Disordered Breathing during in-laboratory polysomnography
- •Ability to read and understand English Language
- •Ability to provide informed consent
排除标准
- •Unstable medical illness within the last month (30 days)
- •Acute / recent upper airway infection
- •Prior use of non-continuous positive airway pressure medical technology therapies prescribed by a physician for the management of obstructive sleep disordered breathing (e.g., Provent®, Winx™, mandibular advancement oral appliances, etc.)
- •Prior use or exposure to CPAP / Bi-Level / or other non-invasive ventilatory modalities
- •Craniofacial or other anatomical anomalies that may predispose patients to upper airway obstruction, or obvious blockage to nasal air flow
- •Patients using opioids or amphetamines will be excluded from the study.
- •Enhanced oxygen requirement (i.e., FiO2>0.21)
- •Patients requiring Bi-Level therapy upon CPAP titration attempt
- •Surgery since the diagnostic PSG
- •Significant recent sedative/hypnotic use likely, in the opinion of the principle investigator, to impair ventilatory control or impact the subsequent titration of either CPAP therapy or Flowrest therapy (including benzodiazepines, antihistamines, imidazopyridines)
- •Significant use of stimulant medications likely, in the opinion of the principle investigator, likely to alter ventilatory or upper airway control and impact the subsequent titration of either CPAP therapy or Flowrest therapy (including amphetamines, high dose caffeine, etc.)
- •Significant neurologic or cardiac pathology likely to seriously impact respiratory effort or ventilatory control (e.g., post CVA with ventilatory impairment)
- •Presence of significant sleep disorders likely to induce hypersomnolence or interfere with the ability to titrate CPAP therapy or Flowrest therapy (including narcolepsy, PLMS/RLS, severe chronic insomnia, non-OSA obesity hypoventilation syndrome, etc.)
- •Unsuitable for inclusion in the opinion of the investigators
结局指标
主要结局
AHI Change (Therapy v Baseline)
时间窗: Acute - single night therapy exposure
Evaluate the change in AHI from baseline for HFT v CPAP therapy
次要结局
- Pulse Oxygen Saturation(Acute single night therapy exposure)
- Respiratory Disturbance Index (RDI)(Acute single night therapy exposure)
- Respiratory Event Related Arousals(Acute single night therapy exposure)
- Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)(Acute single night therapy exposure)