Improving sleep quality for hospital shift workers using lemborexant
The Efficacy of Lemborexant Versus Placebo on Improving Sleep Quality Among Hospital Rotating Shift Workers: A Randomized, Double-Blind, Placebo-Controlled Trial
This study is testing if a medication called lemborexant can help hospital shift workers who have trouble sleeping feel better and improve their sleep quality.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Phramongkutklao College of Medicine and Hospital Academic / other |
| Locations | 1 site (Ratchathewi, Bangkok) |
| Trial ID | NCT06496282 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of lemborexant, an orexin receptor antagonist, in improving sleep quality among hospital rotating shift workers who experience sleep problems. Participants aged 20-60 years with a history of sleep issues related to their work schedule will be enrolled and randomly assigned to receive either lemborexant or a placebo. The study aims to assess changes in sleep efficiency, quality of life, and related symptoms over the course of the trial. By focusing on a specific population that faces unique sleep challenges, this trial seeks to provide valuable insights into the management of sleep disorders in shift workers.
Who should consider this trial
Good fit: Ideal candidates are hospital rotating shift workers aged 20-60 who have been experiencing sleep problems for at least three months.
Not a fit: Patients with untreated mental health conditions, obstructive sleep apnea, or those currently undergoing medication adjustments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and overall well-being for hospital shift workers.
How similar studies have performed: Other studies have explored the use of orexin receptor antagonists for sleep disorders, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Ratchathewi, Bangkok
- Phramongkutklao Hospital — Ratchathewi, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Abisith Dechachongjumroen, MD — Phramongkutklao hospital and College of Medicine
- Study coordinator: Tipvilai Taweepunturat, Pharm.D.
- Email: taribtip@gmail.com
- Phone: 0822956659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.