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