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The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold (LMOSALAT)

2026年7月2日 更新者：Chulalongkorn University

One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial

The goal of this clinical trial is to investigate the 1-month treatment effects of different dose of lemborexant in moderate OSA adult patients (18-65 years of age) with low arousal threshold.

The main questions it aims to answer are:

Primary outcome measure: Apnea/hypopnea index (AHI)

Secondary outcome measure:

  1. Polysomnography parameters

    • Mean and nadir oxygen saturation
    • Sleep efficiency
    • Wake after sleep onset (WASO)
    • Sleep latency
    • Rapid eye movement (REM) latency
    • Percentage of time spent in Non-rapid eye movement (NREM) stage 1-3 and REM stage
    • Arousal index
  2. Oxford Sleep Resistance Test (OSLER) test
  3. Epworth Sleepiness Scale (ESS)
  4. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
  5. Pittsburgh Sleep Quality Index (PSQI)

  6. Actigraphy parameters

    • Total sleep time
    • Sleep efficiency
    • Wake after sleep onset (WASO)
    • Sleep latency

  7. Sleep diary parameters (Appendix 5)

    • Total sleep time
    • Sleep efficiency
    • Wake after sleep onset (WASO)
    • Sleep latency
    • Sleep quality

Researchers will compare placebo to see if there is a difference in AHI.

Participants will

  • participate a total of 3 phases of study (3-crossover trial)
  • each phrase the participants will receive either lemborexant 5 mg, lemborexant 10 mg, or placebo orally per day for 30 days with 2-week washout (depend on intervention arm whether the participants receive which intervention sequence)
  • complete three overnight in-laboratory polysomnography (2-week washout) at day 30 of each phrase
  • monitor actigraphy during day 1 to 29 of intervention of all periods
  • record sleep diary during day 1 to 29 of intervention of all periods
  • complete the OSLER test in the morning of the three overnight test
  • complete questionnaires including: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T), Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention) and the night before overnight in-laboratory polysomnography

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

36

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 泰国
    • Bangkok
      • Pathum Wan、Bangkok、泰国、10330
        • Chulalongkorn University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion criteria

Individuals are eligible for participation in this study if they have all of the followings:

  1. Patient, aged 18 - 65 years at the time of informed consent
  2. Voluntary agreement and capable for giving written informed consent
  3. Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision
  4. Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity)
  5. Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index < 30 events per hour, nadir oxygen saturation as measured by pulse oximetry > 82.5%, and fraction of hypopneas > 58.3%. A score of 2 or above defined a low arousal threshold.
  6. Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit
  7. Habitually sleeping ≥ 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM
  8. Body mass index 18 - 40 kg/m2 Exclusion criteria

Individuals were not eligible for participation in this study if they have any of the followings:

  1. Previous allergy or adverse effects with Lemborexant or other sedatives
  2. Pregnant or breastfeeding
  3. Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
  4. Uncontrolled cardiovascular or cerebrovascular diseases
  5. Neuromuscular diseases
  6. Nasal anatomical defect
  7. Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
  8. Active respiratory disorders other than OSA
  9. Central respiratory events (CAHI) >25% of the total AHI
  10. Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder
  11. Severe hypersomnolence (ESS ≥16)
  12. Peripheral capillary oxygen saturation (SpO2) < 80% for ≥ 5% of total sleep time measured during screening visit
  13. Driving-related sleepiness accident or near misses in the past 12 months
  14. Safety-critical occupation
  15. Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study
  16. Unable to tolerate equipment in this study
  17. Taking any medication that affects sleep or other variable measured in this study
  18. Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers
  19. Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake
  20. Excessive caffeine intake

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Lemborexant 5 mg
Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 5 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 5 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 10 mg arm with same repeat of another 2 phases.
药品：Lemborexant 5 MG [Dayvigo] Period 1
Participants will receive lemborexant 5 mg per day for 30 days during first period
药品：Lemborexant 5 MG [Dayvigo] Period 2
Participant will receive lemborexant 5 mg per day for 30 days during the second period
药品：Lemborexant 5 MG [Dayvigo] Period 3
Participants will receive lemborexant 5 mg per day for 30 days during third period
安慰剂比较：Placebo
Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive placebo per day before sleep for a total of 30 days. On the day 30 participants will receive the placebo 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the lemborexant 5 or 10 mg arm with same repeat of another 2 phases.
药品：Placebo Period 1
Participants will receive placebo 5 mg per day for 30 days during the first period
药品：Placebo Period 2
Participant will receive placebo 5 mg per day for 30 days during the second period
药品：Placebo Period 3
Participants will receive placebo per day for 30 days during third period
实验性的：Lemborexant 10 mg
Participants will receive two treatment sequences. Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 10 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 10 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 5 mg arm with same repeat of another 2 phases.
药品：Lemborexant 10 MG [Dayvigo] Period 1
Participants will receive lemborexant 10 mg per day for 30 days during first period
药品：Lemborexant 10 MG [Dayvigo] Period 2
Participants will receive lemborexant 10 mg per day for 30 days during second period
药品：Lemborexant 10 MG [Dayvigo] Period 3
Participants will receive lemborexant 10 mg per day for 30 days during third period

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Apnea/hypopnea index (AHI)
大体时间：At day 30 during the overnight in-laboratory of each study period
Apnea/hypopnea index (AHI) measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
At day 30 during the overnight in-laboratory of each study period

次要结果测量

结果测量
措施说明
大体时间
Mean and nadir oxygen saturation
大体时间：At day 30 during the overnight in-laboratory of each study period
Mean and nadir oxygen saturation measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
At day 30 during the overnight in-laboratory of each study period
Sleep efficiency
大体时间：At day 30 during the overnight in-laboratory of each study period
Sleep efficiency measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
At day 30 during the overnight in-laboratory of each study period
Wake after sleep onset (WASO)
大体时间：At day 30 during the overnight in-laboratory of each study period
Wake after sleep onset (WASO) measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
At day 30 during the overnight in-laboratory of each study period
Sleep latency
大体时间：At day 30 during the overnight in-laboratory of each study period
Sleep latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
At day 30 during the overnight in-laboratory of each study period
REM latency
大体时间：At day 30 during the overnight in-laboratory of each study period
REM latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
At day 30 during the overnight in-laboratory of each study period
Percentage of time spent in NREM stage 1-3 and REM stage
大体时间：At day 30 during the overnight in-laboratory of each study period
Percentage of time spent in NREM stage 1-3 and REM stage measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores in NREM stage 3 and REM mean better outcome but higher scores in NREM stage 1 and 2 mean worse outcome)
At day 30 during the overnight in-laboratory of each study period
Arousal index
大体时间：At day 30 during the overnight in-laboratory of each study period
Arousal index measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
At day 30 during the overnight in-laboratory of each study period
OSLER error index
大体时间：On the morning of the in-laboratory polysomnography
Oxford Sleep Resistance Test (OSLER) test (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
On the morning of the in-laboratory polysomnography
Epworth Sleepiness Scale (ESS)
大体时间：Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Epworth Sleepiness Scale (ESS) questionnaires (scale: point: minimum 0 point - maximum 24 point; higher scores mean worse outcome)
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
大体时间：Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) (scale: point: minimum 5 point - maximum 20 point; higher scores mean better outcome)
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Pittsburgh Sleep Quality Index
大体时间：Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Pittsburgh Sleep Quality Index (scale: point: minimum 0 point - maximum 21 point; higher scores mean worse outcome)
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Total sleep time
大体时间：During day 1-29 of intervention
Total sleep time measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
During day 1-29 of intervention
Sleep efficiency
大体时间：During day 1-29 of intervention
Sleep efficiency measured by actigraphy (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
During day 1-29 of intervention
Wake after sleep onset (WASO)
大体时间：During day 1-29 of intervention
Wake after sleep onset (WASO) measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
During day 1-29 of intervention
Sleep latency
大体时间：During day 1-29 of intervention
Sleep latency measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
During day 1-29 of intervention
Total sleep time
大体时间：During day 1-29 of intervention
Total sleep time recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
During day 1-29 of intervention
Sleep efficiency
大体时间：During day 1-29 of intervention
Sleep efficiency recorded by sleep diary (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
During day 1-29 of intervention
Wake after sleep onset (WASO)
大体时间：During day 1-29 of intervention
Wake after sleep onset (WASO) recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
During day 1-29 of intervention
Sleep latency
大体时间：During day 1-29 of intervention
Sleep latency recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
During day 1-29 of intervention
Sleep quality
大体时间：During day 1-29 of intervention
Sleep quality recorded by sleep diary (5-point Likert scale of 1-5; higher score mean better outcome)
During day 1-29 of intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chulalongkorn University

调查人员

  • 首席研究员：Sarocha Vivatvakin, MD、Department of Medicine, Faculty of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年6月30日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年7月2日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 0594/69

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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