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
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)
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
Crossover
Lemborexant 5 MG [Dayvigo] Period 1
DrugParticipants will receive lemborexant 5 mg per day for 30 days during first period
Placebo Period 1
DrugParticipants will receive placebo 5 mg per day for 30 days during the first period
Lemborexant 5 MG [Dayvigo] Period 2
DrugParticipant will receive lemborexant 5 mg per day for 30 days during the second period
Placebo Period 2
DrugParticipant will receive placebo 5 mg per day for 30 days during the second period
Lemborexant 5 MG [Dayvigo] Period 3
DrugParticipants will receive lemborexant 5 mg per day for 30 days during third period
Placebo Period 3
DrugParticipants will receive placebo per day for 30 days during third period
Lemborexant 10 MG [Dayvigo] Period 1
DrugParticipants will receive lemborexant 10 mg per day for 30 days during first period
Lemborexant 10 MG [Dayvigo] Period 2
DrugParticipants will receive lemborexant 10 mg per day for 30 days during second period
Lemborexant 10 MG [Dayvigo] Period 3
DrugParticipants will receive lemborexant 10 mg per day for 30 days during third period
Apnea/hypopnea index (AHI)
Apnea/hypopnea index (AHI) measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
Mean and nadir oxygen saturation
Mean and nadir oxygen saturation measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
Sleep efficiency
Sleep efficiency measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Sleep latency
Sleep latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
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