A Prospective, Self-controlled, Feasibility Study to Evaluate Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety event frequency
研究概览
简要总结
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep.
The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance.
Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.
详细描述
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. OSA lead to desaturation and often lead to an arousal.
Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.
The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively low compliance.
Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake. Odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA diagnosed; AHI≥20
- •Male and Female Aged 40 to 70 years old
- •Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study
- •Patient is willing and able to give his/her written informed consent
排除标准
- •Chronic lung disease (including Asthma and COPD)
- •Congestive Heart Failure
- •Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment
- •History of severe nasal allergies or sinusitis or difficulty breathing through the nose
- •Persistent blockage of one or both nostrils
- •Any previous operation or trauma to the nose
- •Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure
- •Any use of antipsychotic, Hypnotic drugs
- •Major neurological diagnosis
- •Active malignant disease including chemotherapy or radiotherapy treatment
- •Pregnant or lactating women
- •Medical history of epilepsy
结局指标
主要结局
Safety event frequency
时间窗: 3 weeks
Device or treatment-related adverse events.
次要结局
- Sleepiness effect(2 weeks)