Moderate OSA patients with low arousal threshold Apnea/Hypopnea Index (AHI) Lemborexant Obstructive Sleep Apnea (OSA) Low Arousal Threshold Polysomnography
Conditions
Interventions
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 pe
Experimental Drug,Experimental Drug,Experimental Drug
Lemborexant 5 mg,Lemborexant 10 mg,Placebo
Sponsors
The Royal College of Physicians of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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 less than 30 events per hour, nadir oxygen saturation as measured by pulse oximetry more than 82.5 %, and fraction of hypopneas more than 58.3%. A score of 2 or above defined a low arousal threshold, 6. Peripheral capillary oxygen saturation (SpO2) more than or equal to 94% measured during screening visit, 7. Habitually sleeping more than or equal to 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
Exclusion criteria: 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) more than 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 more than or equal to 16), 12. Peripheral capillary oxygen saturation (SpO2) less than 80% for more than or equal to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AHI (apnea/hypopnea index) On the 30th day of intervention AHI (apnea/hypopnea index) by polysomnography | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean and nadir oxygen saturation On the 30th day of intervention Mean and nadir oxygen saturation by pulse oximetry,Sleep efficiency On the 30th day of intervention Sleep efficiency by polysomnography,Wake after sleep onset (WASO) On the 30th day of intervention Wake after sleep onset (WASO) by polysomnography,Sleep latency On the 30th day of intervention Sleep latency by polysomnography,REM latency On the 30th day of intervention REM latency by polysomnography,Percentage of time spent in NREM stage 1-3 and REM stage On the 30th day of intervention Percentage of time spent in NREM stage 1-3 and REM stage by polysomnography,Arousal index On the 30th day of intervention Arousal index by polysomnography,OSLER error index In the morning after polysomnography test Oxford Sleep Resistance Test (OSLER) test,Epworth Sleepiness Scale (ESS) Prior to intervention, Night before each in-laboratory polysomnography (30th day) Epworth Sleepiness Scale (ESS) Questionnaires,Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) Prior to intervention, Night before each in-laboratory polysomnography (30th day) Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) ,Total sleep time 1st - 29th day of intervention Actigraphy,Sleep efficiency 1st - 29th day of intervention Actigraphy,Wake after sleep onset (WASO) 1st - 29th day of intervention Actigraphy,Sleep latency 1st - 29th day of intervention Actigraphy ,Total sleep time 1st - 29th day of intervention Sleep diary ,Sleep efficiency 1st - 29th day of intervention Sleep diary,Wake after sleep onset (WASO) 1st - 29th day of intervention Sleep diary,Sleep latency 1st - 29th day of intervention Sleep diary,Sleep quality 1st - 29th day of intervention Sleep diary,Pittsburgh Sleep Quality Index (PSQI) Prior to intervention, Night before each in-laboratory polysomnography (30th day) Pittsburgh Sleep Quality Index (PSQI) Questionnaires | — |
Countries
Thailand
Contacts
Public ContactSarocha Vivatvakin
Department of Physiology, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed