Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep
研究概览
简要总结
In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.
详细描述
40 adults with mild OSA (< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 100 years
- •RDI between 5 - 15
- •all races
- •both sexes
排除标准
- •craniofacial, syndromic, neurological abnormalities
- •current or previous use of Singular, Rhinocort within last 6 months
- •acute upper respiratory infections
- •recent nasal trauma, nasal surgery, nasal septum perforation
- •known immunodeficiency or under going immunosuppressant therapy
- •current therapy with drugs that interact with Montelukast or Budesonide
研究组 & 干预措施
budesonide and montelukast
treatment arm
干预措施: budesonide and montelukast (Drug)
placebo
sugar pill, salt water nasal spray
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep
时间窗: 3 months
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
次要结局
未报告次要终点
研究者
Ann M. Romaker, MD
UMKC sleep fellowship program director
Romaker & Associates