Actively Recruiting
Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers
Led by Phramongkutklao College of Medicine and Hospital · Updated on 2024-07-11
50
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
P
Phramongkutklao College of Medicine and Hospital
Lead Sponsor
S
Silpakorn University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20-60 years
- Rotating shift workers for at least 3 months and continuing shifts until study ends
- Sleep problems with total sleep time less than 6 hours and/or ineffective sleep according to ICSD-3 criteria
- Sleepiness while working shifts with Epworth Sleepiness Scale score of 10 or higher
You will not qualify if you...
- Taking drugs that strongly affect CYP3A4 enzyme
- Untreated mental health disorders or ongoing medication changes
- Severe liver problems (Child-Pugh C)
- Pregnancy or breastfeeding
- Ongoing medication adjustments for mental health, neurology, insomnia, or contraceptives
- Diagnosed obstructive sleep apnea, restless leg syndrome, circadian rhythm disorders, or narcolepsy
- Complex sleep behaviors like sleep driving or sleep cooking
- High depression or anxiety scores (HAM-D or HAM-A 24 or above)
- Consuming more than 400 mg caffeine daily or unable to avoid caffeine 4 hours before bedtime
- Substance abuse or alcoholism in past 2 years
- High alcohol intake or inability to control drinking
- Cannabis use within past week
- Serious underlying diseases such as stroke, heart rhythm problems, lung disease, liver or kidney failure, cognitive impairment, cancer, or chronic pain
- Use of benzodiazepines or similar drugs for insomnia
- Frequent nighttime urination
- Mental health issues affecting safety or recent suicidal thoughts or behaviors
- Major surgery planned during study
- Recent travel across more than 3 time zones
- Allergy to lemborexant or its ingredients
- Previous participation in lemborexant studies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Phramongkutklao Hospital
Ratchathewi, Bangkok, Thailand, 10400
Actively Recruiting
Research Team
T
Tipvilai Taweepunturat, Pharm.D.
CONTACT
P
Pasiri Sithinamsuwan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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