NCT07683442尚未招募1 期
One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Apnea/hypopnea index (AHI)
研究概览
简要总结
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:
- 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
- Oxford Sleep Resistance Test (OSLER) test
- Epworth Sleepiness Scale (ESS)
- Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
- Pittsburgh Sleep Quality Index (PSQI)
- Actigraphy parameters
- Total sleep time
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals are eligible for participation in this study if they have all of the followings:
- •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 < 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.
- •Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit
- •Habitually sleeping ≥ 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
- •Individuals were not eligible for participation in this study if they have any of the followings:
- •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
- •Central respiratory events (CAHI) >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 ≥16)
- •Peripheral capillary oxygen saturation (SpO2) < 80% for ≥ 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
结局指标
主要结局
Apnea/hypopnea index (AHI)
时间窗: 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)
次要结局
- Mean and nadir oxygen saturation(At day 30 during the overnight in-laboratory of each study period)
- Sleep efficiency(At day 30 during the overnight in-laboratory of each study period)
- Wake after sleep onset (WASO)(At day 30 during the overnight in-laboratory of each study period)
- Sleep latency(At day 30 during the overnight in-laboratory of each study period)
- REM latency(At day 30 during the overnight in-laboratory of each study period)
- Percentage of time spent in NREM stage 1-3 and REM stage(At day 30 during the overnight in-laboratory of each study period)
- Arousal index(At day 30 during the overnight in-laboratory of each study period)
- OSLER error index(On the morning of the in-laboratory polysomnography)
- Epworth Sleepiness Scale (ESS)(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)(Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period)
- Pittsburgh Sleep Quality Index(Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period)
- Total sleep time(During day 1-29 of intervention)
- Sleep efficiency(During day 1-29 of intervention)
- Wake after sleep onset (WASO)(During day 1-29 of intervention)
- Sleep latency(During day 1-29 of intervention)
- Sleep quality(During day 1-29 of intervention)
研究者
研究点 (1)
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