Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Daytime Sleepiness (ESS)
研究概览
简要总结
The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.
详细描述
Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group.
In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Body Mass Index equal to 32 or less
- •Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
- •Symptoms of daytime sleepiness
排除标准
- •Septal deviation or nasal obstruction
- •Nasal polyps
- •Severe seasonal allergies
- •Soft palate length insufficient to accommodate implants
- •Fujita Modified Mallampati Class 3
- •Large tonsils
- •Lingual tonsil hypertrophy
- •Hypopharyngeal obstruction
- •Previous pharyngeal surgery
- •Previous upper respiratory tract cancer or radiation therapy
- •Active respiratory tract infection
- •Dysphagia or speech disorder
- •Neurologic disorder
- •Unstable psychiatric disorder
- •Pregnant or breastfeeding
- •History of falling asleep driving or MVA due to sleepiness
- •Currently on CPAP therapy or other device for OSA
- •Other sleep disorders
结局指标
主要结局
Daytime Sleepiness (ESS)
Apnea/Hypopnea Index (AHI)
次要结局
- Sleep Related Quality of Life (FOSQ)
- Reaction Time Testing (PVT)
- Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)