NCT06496282

Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

The Efficacy of Lemborexant Versus Placebo on Improving Sleep Quality Among Hospital Rotating Shift Workers: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep

Interventions

Type	Name	Description
DRUG	Lemborexant	The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
DRUG	Placebo	The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-05-31
• Completion: 2026-07-01
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: Thailand