A Phase 3 interventional study of Lemborexant and Placebo in Sleep, sponsored by Phramongkutklao College of Medicine and Hospital. Recruiting at 1 site in Thailand. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Phramongkutklao College of Medicine and Hospital · Phase 3, Interventional, and Treatment
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.
Phramongkutklao College of Medicine and Hospital is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lemborexant 5 mg 1 tab hs before bedtime
Drug: Lemborexant
Placebo of Lemborexant 5 mg 1 tab hs before bedtime
Drug: Placebo
The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
Also known as: Dayvigo
The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study
Also known as: Dayvigo placebo
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.
Time frame: 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
Time frame: 1 week after screening and 6 weeks after lemborexant administration
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
Time frame: 1 week after screening and 6 weeks after lemborexant administration
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week after screening and 6 weeks after lemborexant administration
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Phramongkutklao College of Medicine and Hospital