Status:
RECRUITING
Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers
Lead Sponsor:
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsors:
Silpakorn University
Conditions:
Sleep
Eligibility:
All Genders
20-60 years
Phase:
PHASE3
Brief 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 dev...
Eligibility Criteria
Inclusion
- Age 20-60 years
- Rotating shift workers at least 3 months and continue rotating shift until end of study
- Participants who have sleep problem especially total sleep time lower than 6 hours and/or unable to sleep effectively according to the ICSD-3 at least 1 criteria
- Participants who have sleepy while working and have Epworth sleepiness scale in shift grater than or equal to 10 points
Exclusion
- Receiving drug interaction esp. drugs induced CYP3A4 (moderate to severe) or drugs inhibited CYP3A4 (moderate to severe)
- Untreatment mental health disease or in process medication adjustment
- Hepatic function in Chid-Pugh C
- Pregnancy
- Breastfeeding
- Participants who in process medication adjustment such as mental heat, neurology, insomnia, contraceptive drugs.
- Diagnosis obstructive sleep apnea (OSA) with or without CPAP using or diagnosis restless leg syndrome or circadian rhythm disorders or narcolepsy
- Complex sleep behaviors such as sleep driving, sleep phone, sleep cooking
- HAM-D grater than or equal to 24 points
- HAM-A grater than or equal to 24 points
- Caffeine taking grater than 400 mg/day or can't not hold caffeine 4 hours before bedtime
- Substance abuse or alcoholism within 2 years ago
- Alcohol intake grater than 140 g of alcohol per week in female or intake grater than 210 g of alcohol per week in male or can't control alcohol drinking greater than 20 g of alcohol per day or can't hold alcohol within 3 hours before bedtime
- Cannabinoid using within 1 week ago
- Participants who have underlying disease such as stroke, atrial fibrillation, chronic obstructive pulmonary disease, hepatic impairment, severe renal impairment, cognitive impairment, cancer, chronic pain
- Participant who use of benzodiazepine or non-benzodiazepine in treatment of insomnia
- Participant who have nocturia problem
- Participant who have mental health problem which the physician conclude it affect the safety of participant
- Participant who have suicidal thinking with or without plan or have suicidal behaviors within 10 years ago
- Participant who have major surgery schedule during the study
- Travel across greater than 3 time zone within 2 weeks before include participant
- Allergy of lemborexant or component of lemborexant
- Have previously participated in study that used lemborexant
- Participant who
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06496282
Start Date
August 1 2024
End Date
July 1 2026
Last Update
July 11 2024
Active Locations (1)
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1
Phramongkutklao Hospital
Ratchathewi, Bangkok, Thailand, 10400