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New treatment option for Sleep
Official title Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers
ClinicalTrials.gov ID: NCT06496282
What this study is testing
What is Lemborexant?
Lemborexant is an investigational medicine, being studied as a potential treatment for sleep.
Also referred to as Dayvigo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participants who have sleepy while working and have Epworth sleepiness scale in shift grater than or equal to 10 points
You likely can't join if
- 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.
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ratchathewi, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ratchathewi, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.