Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

ConditionSleep

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age20-60

SponsorPhramongkutklao College of Medicine and Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Lemborexant
Drug
The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
Placebo
Drug
The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Lemborexant 5 mgExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group

Sleep quality improvement evaluated by physician with actigraphy (Fitbit inspire 2) after lemborexant administration in 3 and 6 week.

Time frame

1 week after screening, 3 and 6 weeks after lemborexant administration

Changing of Brian-derived neurotropic (BDNF) in lemborexant 5 mg compare with placebo group

Blood sample of BDNF changing in 1 week after screening and 6 weeks after lemborexant administration

Time frame