Sleep
Conditions
Keywords
Shift workers, Improving sleep, Lemborexant, Orexin receptor antagonists, Hospital rotating shift workers, Rotating shift workers
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 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.
Interventions
DRUGLemborexant
The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
DRUGPlacebo
The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study
Sponsors
Silpakorn University
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group | 1 week after screening, 3 and 6 weeks after lemborexant administration | Sleep quality improvement evaluated by physician with actigraphy (Fitbit inspire 2) after lemborexant administration in 3 and 6 week. |
| Changing of Brian-derived neurotropic (BDNF) in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Blood sample of BDNF changing in 1 week after screening and 6 weeks after lemborexant administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of depression symptoms in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Depression symptoms improvement evaluated by physician with Hamilton depression rating scale (HAM-D) after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of anxiety symptoms in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Anxiety symptoms improvement evaluated by physician with Hamilton anxiety rating scale (HAM-A) after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration |
| Assessment effective of sleepiness level in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Sleepiness level improvement evaluated by physician with Epworth sleepiness scale after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of quality of life in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Quality of life improvement evaluated by physician with EuroQOL five dimensions questionnaires (EQ-5D )in 1 week after screening and 6 weeks after lemborexant administration |
| Changing of CRP, IL-6 and TNF-alpha in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Blood sample of CRP, IL-6 and TNF-alpha changing in 1 week after screening and 6 weeks after lemborexant administration |
| Assessment of cognition in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Cognition improvement evaluated by physician with Motreal cognitive assessment (MOCA), Grooved pegboard test and Digit symbol substitution test in1 week after screening and 6 weeks after lemborexant administration |
| Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group | 1 week after screening and 6 weeks after lemborexant administration | Sleep quality improvement evaluated by physician with Pittsburgh sleep quality index (PSQI) in 1 week after screening and 6 weeks after lemborexant administration |
Countries
Thailand
Contacts
Primary ContactTipvilai Taweepunturat, Pharm.D.
Backup ContactPasiri Sithinamsuwan, MD
Outcome results
None listed