Endotypic Traits and Obstructive Sleep Apnea Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).
详细描述
This is a prospective cohort (observational) study of 150 participants with moderate to severe obstructive sleep apnea (OSA) unable to tolerate positive airway pressure who are undergoing drug-induced sleep endoscopy (DISE), including measurement of upper airway closing pressure (Pclose), and tissue-repositioning soft palate surgery. Before and 6 months after surgery, the investigators will measure OSA severity (apnea-hypopnea index) with sleep studies (polysomnograms). Using a recently-validated polysomnography-based signal processing algorithm, the investigators will systematically assess the underlying mechanisms of OSA (traits) and airflow shape (consistent with palate obstruction). The expected 90 participants without resolution of OSA after surgery (surgery failures) will participate in an experimental randomized crossover study of acetazolamide (1 month) and acetazolamide/eszopiclone combination (1 month). Polysomnograms will be performed with each treatment, with algorithm-based determination of traits.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥21 years;
- •moderate to severe OSA (obstructive AHI ≥ 15 events/hour);
- •central/mixed apnea index <5 events/hour;
- •intolerance of positive airway pressure (defined as use < 2 hours/night at least 5 nights/week);
- •intolerance or poor candidate for oral appliance;
- •participant has provided informed consent for palate surgery as part of their standard of care;
- •tonsil size 0-2+ (without markedly enlarged tonsils that have high surgical success rates);
- •DISE without evidence of complete tongue-related obstruction (reflecting poorer results with isolated palate surgery);
- •medications stable for ≥2 months;
- •body mass index <35 kg/m2;
- •absence of uncontrolled nasal obstruction;
- •no prior pharyngeal surgery other than tonsillectomy;
- •no neurologic, cardiac or pulmonary disorders;
- •absence of psychiatric disorder except for treated depression or mild anxiety;
- •no co-existing sleep disorder, such as narcolepsy, chronic insomnia, or restless legs syndrome;
- •no use of hypnotics, anxiolytics, stimulants, or sedating antidepressants;
- •no near-miss or prior motor vehicle crash due to sleepiness in past 12 months; and
- •<3 caffeinated beverages daily.
排除标准
- •history of allergic reaction to either of the study drugs;
- •subjects with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;
- •subjects with a history of hypersensitivity to either of the two study drugs;
- •subjects who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;
- •subjects with severe kidney disease or severe liver disease;
- •subjects with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide);
- •subjects on ketoconazole or other strong CYP3A4 inhibitors (these will increase eszopiclone blood levels);
- •pregnancy; and
- •alcohol or substance abuse.
研究组 & 干预措施
Acetazolamide
Treatment with acetazolamide 500 mg nightly for 1 month.
干预措施: Acetazolamide 500 MG QHS (Drug)
Acetazolamide/Eszopiclone
Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
干预措施: Acetazolamide 500 MG QHS (Drug)
Acetazolamide/Eszopiclone
Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.
干预措施: Eszopiclone 3 mg QHS (Drug)
结局指标
主要结局
Apnea-hypopnea index
时间窗: 6 months
apneas plus hypopneas per hour of sleep
次要结局
未报告次要终点
研究者
Eric J. Kezirian, MD, MPH
Professor
University of California, Los Angeles