A Randomized, Double-blind, Placebo-Controlled Trial on the Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 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 randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) is to compare 1 night of 5 mg Lemborexant to placebo administered before sleep in 10 moderate to severe OSA patients with low arousal threshold
The main questions it aims to answer are:
- The effect of Lemborexant on apnea/hypopnea index (AHI) in moderate-to-severe OSA patients with low arousal threshold.
- The effect of Lemborexant on the following parameters in moderate-to-severe OSA patients with low arousal threshold.
- Arousal threshold
- Mean and nadir oxygen saturation
- Sleep latency
- Sleep efficiency
- Wake after sleep onset (WASO)
- Percentage of time spent in NREM stage 1-3 and REM stage
- Stanford Sleepiness Scale Questionnaire in the morning
- The Oxford Sleep Resistance Test (OSLER) test
Participants will
- complete two overnight in-laboratory polysomnography (1-week washout)
- complete the OSLER test in the morning of the two overnight test
Researchers will compare with the placebo group to see if there is a difference in AHI
详细描述
Research Design A randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) comparing 1 night of 5 mg Lemborexant to placebo administered before sleep.
Research Methodology Participants A total of 10 moderate to severe OSA patients with low arousal threshold are randomized 1:1 to either Lemborexant or placebo. The participants will complete two overnight in-laboratory polysomnography (1-week washout). Next-morning alertness will also be assessed using OSLER test, respectively.
Inclusion criteria
Eligible, healthy individuals with all the followings:
- Untreated OSA patient 18 - 65 years of age
- AHI ≥15 events/h of sleep
- Low arousal threshold
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
- Double (Participant, Care Provider)
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
- •Untreated OSA patient 18 - 65 years of age(49)
- •AHI ≥15 events/h of sleep (moderate to severe)(23, 49)
- •Low arousal threshold was defined using previously recommended criteria which allocated a score of 1 to each criterion that was satisfied: (apnea-hypopnea index, <30 events per hour) + (nadir oxygen saturation as measured by pulse oximetry >82.5%) + (fraction of hypopneas >58.3%). A score of 2 or above defined a low arousal threshold(50) (low arousal threshold defined as esophageal pressure values are 0 to -15 cmH2O)(27)
排除标准
- •Previous allergy or adverse effects with Lemborexant or other sedatives - Taking any medication that affects sleep or other variable measured in this study - Pregnant or nursing mothers - Respiratory disorders other than OSA - Comorbid disease of poor controlled or resistant hypertension, uncontrolled cardiovascular or cerebrovascular disease
- •Using CPAP or other dental devices
- •Unable to tolerate equipment in this study
研究组 & 干预措施
Lemborexant
Patients will receive two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period The participants will receive Lemborexant 5 mg per day 5 minutes before lights-out for one dose for the first overnight sleep test of the experiment. After 1 week wash-out period, the participants will cross to the placebo arm and receive placebo 5 minutes before lights-out for one dose for the second overnight sleep test of the experiment.
干预措施: Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1 (Drug)
Lemborexant
Patients will receive two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period The participants will receive Lemborexant 5 mg per day 5 minutes before lights-out for one dose for the first overnight sleep test of the experiment. After 1 week wash-out period, the participants will cross to the placebo arm and receive placebo 5 minutes before lights-out for one dose for the second overnight sleep test of the experiment.
干预措施: Placebo Day 2 (Drug)
Placebo
Patients will receive two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period The participants will receive placebo 5 minutes before lights-out for one dose for the first overnight sleep test of the experiment. After 1 week wash-out period, the participants will cross to the Lemborexant arm and receive Lemborexant 5 mg per day 5 minutes before lights-out for one dose for the second overnight sleep test of the experiment.
干预措施: Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2 (Drug)
Placebo
Patients will receive two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period The participants will receive placebo 5 minutes before lights-out for one dose for the first overnight sleep test of the experiment. After 1 week wash-out period, the participants will cross to the Lemborexant arm and receive Lemborexant 5 mg per day 5 minutes before lights-out for one dose for the second overnight sleep test of the experiment.
干预措施: Placebo Day 1 (Drug)
结局指标
主要结局
apnea/hypopnea index (AHI)
时间窗: through study completion, one week
AHI
次要结局
- Percentage of time spent in NREM stage 1-3 and REM stage(through study completion, one week)
- The Oxford Sleep Resistance Test (OSLER) test(through study completion, one week)
- Mean and nadir oxygen saturation(through study completion, one week)
- Sleep latency (Time the patients fall asleep)(through study completion, one week)
- Sleep efficiency (Time the patients actually sleep through out the experiment)(through study completion, one week)
- Wake after sleep onset (WASO)(through study completion, one week)