TCTR20260715008招募中1/2 期
The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients with Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Patient, aged 18 - 65 years at the time of informed consent,
- •Voluntary agreement and capable for giving written informed consent,
- •Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision,
- •Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity),
- •Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index less than 30 events per hour, nadir oxygen saturation as measured by pulse oximetry more than 82.5 %, and fraction of hypopneas more than 58.3%. A score of 2 or above defined a low arousal threshold,
- •Peripheral capillary oxygen saturation (SpO2) more than or equal to 94% measured during screening visit,
- •Habitually sleeping more than or equal to 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM,
- •Body mass index 18 - 40 kg/m2
排除标准
- •Previous allergy or adverse effects with Lemborexant or other sedatives,
- •Pregnant or breastfeeding,
- •Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators opinion,
- •Uncontrolled cardiovascular or cerebrovascular diseases,
- •Neuromuscular diseases,
- •Nasal anatomical defect,
- •Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators opinion,
- •Active respiratory disorders other than OSA
- •9 Central respiratory events (CAHI) more than 25% of the total AHI,
- •Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder,
- •Severe hypersomnolence (ESS more than or equal to 16),
- •Peripheral capillary oxygen saturation (SpO2) less than 80% for more than or equal to 5% of total sleep time measured during screening visit,
- •Driving-related sleepiness accident or near misses in the past 12 months,
- •Safety-critical occupation,
- •Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study,
- •Unable to tolerate equipment in this study,
- •Taking any medication that affects sleep or other variable measured in this study,
- •Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers,
- •Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake,
- •Excessive caffeine intake
研究者
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