NCT06677151招募中不适用
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in severity of apnea hypopnea index (AHI)
研究概览
简要总结
This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity and willingness to sign consent
- •Patient willingness to commit to and complete study over a 30-day time period
- •Confirmed diagnosis of moderate to severe OSA (AHI >= 15)
- •OSA caused by upper airway obstruction
- •CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
- •Adequate manual dexterity to demonstrate ability to self-insert and remove device
排除标准
- •Within 3 months of initiating CPAP use, and actively using CPAP
- •Supraglottic airway collapse
- •Distal airway stenosis
- •Tracheobronchomalacia
- •Currently pregnant
- •Active COVID-19 infection
- •Need for anticoagulative therapy
- •Severe nasal allergies
- •Bleeding disorder
- •More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time
- •Restrictive thoracic disorders
- •Silicone, lidocaine, neosynephrine allergy
- •Recurrent epistaxis
- •Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure
研究组 & 干预措施
Nasopharyngeal airway device
Experimental
A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home.
干预措施: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device (Device)
结局指标
主要结局
Change in severity of apnea hypopnea index (AHI)
时间窗: Baseline (day 0), 30 days
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
次要结局
未报告次要终点
研究者
Louise O'Brien
Professor, Sleep Medicine
University of Michigan
研究点 (2)
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