Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers
NCT Number: NCT06496282
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Sleep
Interventions: DRUG: Lemborexant|DRUG: Placebo
Sponsor: Phramongkutklao College of Medicine and Hospital
Collaborators: Silpakorn University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-07
Locations: Phramongkutklao Hospital, Ratchathewi, Bangkok, 10400, Thailand

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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|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