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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
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
Sleep diary parameters (Appendix 5)
Researchers will compare placebo to see if there is a difference in AHI.
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemborexant 5 mg | Experimental | 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 per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 5 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 10 mg arm with same repeat of another 2 phases. |
|
| Placebo | Placebo Comparator | 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 placebo per day before sleep for a total of 30 days. On the day 30 participants will receive the placebo 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the lemborexant 5 or 10 mg arm with same repeat of another 2 phases. |
|
| Lemborexant 10 mg | Experimental | 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 10 mg per day before sleep for a total of 30 days. On the day 30 participants will receive the lemborexant 10 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography. After 2 week wash-out period, the participants will cross to the placebo or lemborexant 5 mg arm with same repeat of another 2 phases. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant 5 MG [Dayvigo] Period 1 | Drug | Participants will receive lemborexant 5 mg per day for 30 days during first period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At day 30 during the overnight in-laboratory of each study period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and nadir oxygen saturation | Mean and nadir oxygen saturation measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome) | At day 30 during the overnight in-laboratory of each study period |
| Sleep efficiency |
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Inclusion criteria
Individuals are eligible for participation in this study if they have all of the followings:
Individuals were not eligible for participation in this study if they have any of the followings:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarocha Vivatvakin, MD | Contact | 66879310233 | sarocha.v@chula.ac.th | |
| Naricha Chirakalwasan, MD | Contact | 662-649-4037 | narichac@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarocha Vivatvakin, MD | Department of Medicine, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Pathum Wan | Bangkok | 10330 | Thailand |
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| Placebo Period 1 | Drug | Participants will receive placebo 5 mg per day for 30 days during the first period |
|
| Lemborexant 5 MG [Dayvigo] Period 2 | Drug | Participant will receive lemborexant 5 mg per day for 30 days during the second period |
|
| Placebo Period 2 | Drug | Participant will receive placebo 5 mg per day for 30 days during the second period |
|
| Lemborexant 5 MG [Dayvigo] Period 3 | Drug | Participants will receive lemborexant 5 mg per day for 30 days during third period |
|
| Placebo Period 3 | Drug | Participants will receive placebo per day for 30 days during third period |
|
| Lemborexant 10 MG [Dayvigo] Period 1 | Drug | Participants will receive lemborexant 10 mg per day for 30 days during first period |
|
| Lemborexant 10 MG [Dayvigo] Period 2 | Drug | Participants will receive lemborexant 10 mg per day for 30 days during second period |
|
| Lemborexant 10 MG [Dayvigo] Period 3 | Drug | Participants will receive lemborexant 10 mg per day for 30 days during third period |
|
Sleep efficiency measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome) |
| At day 30 during the overnight in-laboratory of each study period |
| 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) | At day 30 during the overnight in-laboratory of each study period |
| Sleep latency | Sleep latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome) | At day 30 during the overnight in-laboratory of each study period |
| REM latency | REM latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome) | At day 30 during the overnight in-laboratory of each study period |
| Percentage of time spent in NREM stage 1-3 and REM stage | Percentage of time spent in NREM stage 1-3 and REM stage measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores in NREM stage 3 and REM mean better outcome but higher scores in NREM stage 1 and 2 mean worse outcome) | At day 30 during the overnight in-laboratory of each study period |
| Arousal index | Arousal index measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome) | At day 30 during the overnight in-laboratory of each study period |
| OSLER error index | Oxford Sleep Resistance Test (OSLER) test (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome) | On the morning of the in-laboratory polysomnography |
| Epworth Sleepiness Scale (ESS) | Epworth Sleepiness Scale (ESS) questionnaires (scale: point: minimum 0 point - maximum 24 point; higher scores mean worse outcome) | 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) | Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) (scale: point: minimum 5 point - maximum 20 point; higher scores mean better outcome) | Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period |
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (scale: point: minimum 0 point - maximum 21 point; higher scores mean worse outcome) | Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period |
| Total sleep time | Total sleep time measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome) | During day 1-29 of intervention |
| Sleep efficiency | Sleep efficiency measured by actigraphy (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome) | During day 1-29 of intervention |
| Wake after sleep onset (WASO) | Wake after sleep onset (WASO) measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome) | During day 1-29 of intervention |
| Sleep latency | Sleep latency measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome) | During day 1-29 of intervention |
| Total sleep time | Total sleep time recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome) | During day 1-29 of intervention |
| Sleep efficiency | Sleep efficiency recorded by sleep diary (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome) | During day 1-29 of intervention |
| Wake after sleep onset (WASO) | Wake after sleep onset (WASO) recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome) | During day 1-29 of intervention |
| Sleep latency | Sleep latency recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome) | During day 1-29 of intervention |
| Sleep quality | Sleep quality recorded by sleep diary (5-point Likert scale of 1-5; higher score mean better outcome) | During day 1-29 of intervention |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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