Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
研究概览
简要总结
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI > 10 events/h during NREM supine sleep
排除标准
- •Any medical condition other than well controlled hypertension and mild diabetes.
- •Any medication known to influence breathing, sleep/arousal, or muscle physiology.
- •Claustrophobia.
- •Inability to sleep supine.
- •Allergy to any of the medications tested in the protocol.
- •History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.
- •Individuals with underlying cardiac disease, such as arrhythmias.
- •Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.
- •For women: Pregnancy.
- •Pulmonary hypertension
- •Severe OSA with a mean SaO2 lower than 88%
研究组 & 干预措施
Placebo
Placebo capsule before bedtime
干预措施: Placebo oral capsule (Drug)
LTM1201AZ
LTM1201AZ capsule before bedtime
干预措施: LTM1201AZ (Drug)
LTM1201AT
LTM1201AT capsule before bedtime
干预措施: LTM1201AT (Drug)
LTM1201AG
LTM1201AG capsule before bedtime
干预措施: LTM1201AG (Drug)
LTM1201AD
LTM1201AD capsule before bedtime
干预措施: LTM1201AD (Drug)
结局指标
主要结局
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
时间窗: 3 nights (treatment duration)
Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive \>50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour.
次要结局
未报告次要终点
研究者
Scott Aaron Sands
Principal investigator
Brigham and Women's Hospital