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| Name | Class |
|---|---|
| Silpakorn University | OTHER |
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Shift Work Sleep Disorder (SWSD) are caused by working shifts with a wake-up schedule and sleeping in a way that is different from the natural way of sleeping and avoiding sleep usually results in deviations. of the biological clock (Biological clock), which is an important cause of sleep problems including insomnia, excessive sleepiness or daytime sleepiness these problems was associated cadiovascular events, decrease quality of life and long term working. At the present there are limited information regarding the effectiveness of medications used to promote sleep in shift workers. Lemborexant is specific in binding to orexin type 2, which has a direct effect on sleep. and there are limited biomarkers monitoring from the use of lemborexant including still not found. Which studies have followed depressive symptoms, anxiety symptoms and cognition from a group of people with insomnia, the aim of study to assessment effectiveness of lemborexant on sleep efficiency, quality of life, symptoms of depression, cognition, BDNF, CRP, IL-6 and TNF-alpha levels. of volunteers working on rotating shifts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemborexant 5 mg | Experimental | Lemborexant 5 mg 1 tab hs before bedtime |
|
| Placebo | Placebo Comparator | Placebo of Lemborexant 5 mg 1 tab hs before bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant | Drug | The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group | Sleep quality improvement evaluated by physician with actigraphy (Fitbit inspire 2) after lemborexant administration in 3 and 6 week. | 1 week after screening, 3 and 6 weeks after lemborexant administration |
| Changing of Brian-derived neurotropic (BDNF) in lemborexant 5 mg compare with placebo group | Blood sample of BDNF changing in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment effective of sleepiness level in lemborexant 5 mg compare with placebo group | Sleepiness level improvement evaluated by physician with Epworth sleepiness scale after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tipvilai Taweepunturat, Pharm.D. | Contact | 0822956659 | taribtip@gmail.com | |
| Pasiri Sithinamsuwan, MD | Contact | 0832367772 | pasiripmk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tipvilai Taweepunturat, Pharm.D. | Faculty of Pharmacy Siam University | Study Chair |
| Abisith Dechachongjumroen, MD | Phramongkutklao hospital and College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramongkutklao Hospital | Recruiting | Ratchathewi | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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| Placebo | Drug | The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study |
|
|
| Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group | Sleep quality improvement evaluated by physician with Pittsburgh sleep quality index (PSQI) in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of depression symptoms in lemborexant 5 mg compare with placebo group | Depression symptoms improvement evaluated by physician with Hamilton depression rating scale (HAM-D) after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of anxiety symptoms in lemborexant 5 mg compare with placebo group | Anxiety symptoms improvement evaluated by physician with Hamilton anxiety rating scale (HAM-A) after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of cognition in lemborexant 5 mg compare with placebo group | Cognition improvement evaluated by physician with Motreal cognitive assessment (MOCA), Grooved pegboard test and Digit symbol substitution test in1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of quality of life in lemborexant 5 mg compare with placebo group | Quality of life improvement evaluated by physician with EuroQOL five dimensions questionnaires (EQ-5D )in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Changing of CRP, IL-6 and TNF-alpha in lemborexant 5 mg compare with placebo group | Blood sample of CRP, IL-6 and TNF-alpha changing in 1 week after screening and 6 weeks after lemborexant administration | 1 week after screening and 6 weeks after lemborexant administration |
| Wananwat Danworapong, MD |
| Phramongkutklao hospital and College of Medicine |
| Principal Investigator |
| Juthathip Suphanklang, BCP | Phramongkutklao hospital and College of Medicine | Study Director |
| Pasiri Sithinamsuwan, MD | Phramongkutklao hospital and College of Medicine | Study Director |