Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

NCT ID: NCT06496282

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-07-31

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lemborexant 5 mg

Lemborexant 5 mg 1 tab hs before bedtime

Group Type: EXPERIMENTAL

Lemborexant

Intervention Type: DRUG

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

Placebo

Placebo of Lemborexant 5 mg 1 tab hs before bedtime

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Lemborexant

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Dayvigo; Dayvigo placebo

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Silpakorn University

OTHER

Sponsor Role: collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tipvilai Taweepunturat, Pharm.D.

Role: STUDY_CHAIR

Faculty of Pharmacy Siam University

Abisith Dechachongjumroen, MD

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao hospital and College of Medicine

Wananwat Danworapong, MD

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao hospital and College of Medicine

Juthathip Suphanklang, BCP

Role: STUDY_DIRECTOR

Phramongkutklao hospital and College of Medicine

Pasiri Sithinamsuwan, MD

Role: STUDY_DIRECTOR

Phramongkutklao hospital and College of Medicine

Locations

Phramongkutklao Hospital

Ratchathewi, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Tipvilai Taweepunturat, Pharm.D.

Role: CONTACT

taribtip@gmail.com

0822956659

Pasiri Sithinamsuwan, MD

Role: CONTACT

pasiripmk@gmail.com

0832367772

Facility Contacts

Tipvilai Taweepunturat, Pharm.D.

Role: primary

taribtip@gmail.com

0822956659

Pasiri Sithinamsuwan, MD

Role: backup

mailto:pasiripmk@gmail.com

0832367772

Other Identifiers

LEMY-2024

Identifier Type: -

Identifier Source: org_study_id