Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

NCT06496282 | Recruiting Phase 3

• 1 other identifier: LEMY-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Shift workers; Improving sleep; Lemborexant; Orexin receptor antagonists; Hospital rotating shift workers; Rotating shift workers

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  1 week after screening and 6 weeks after lemborexant administration

Secondary Outcomes (7)

• Assessment effective of sleepiness level in lemborexant 5 mg compare with placebo group

  1 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

• Assessment of depression symptoms in lemborexant 5 mg compare with placebo group

  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

• Assessment of cognition in lemborexant 5 mg compare with placebo group

  1 week after screening and 6 weeks after lemborexant administration

Study Arms (2)

Lemborexant 5 mg

EXPERIMENTAL

Lemborexant 5 mg 1 tab hs before bedtime

Drug: Lemborexant

Placebo

PLACEBO COMPARATOR

Placebo of Lemborexant 5 mg 1 tab hs before bedtime

Drug: Placebo

Interventions

Lemborexant DRUG

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

Also known as: Dayvigo

Lemborexant 5 mg

Placebo DRUG

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

Also known as: Dayvigo placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 least 1 criteria
• Participants who have sleepy while working and have Epworth sleepiness scale in shift grater than or equal to 10 points

You may not qualify 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.
• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead
• Silpakorn University: collaborator

Study Sites (1)

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

lemborexant

Study Officials

• Tipvilai Taweepunturat, Pharm.D.

  Faculty of Pharmacy Siam University

  STUDY CHAIR

• Abisith Dechachongjumroen, MD

  Phramongkutklao hospital and College of Medicine

  PRINCIPAL INVESTIGATOR

• Wananwat Danworapong, MD

  Phramongkutklao hospital and College of Medicine

  PRINCIPAL INVESTIGATOR

• Juthathip Suphanklang, BCP

  Phramongkutklao hospital and College of Medicine

  STUDY DIRECTOR

• Pasiri Sithinamsuwan, MD

  Phramongkutklao hospital and College of Medicine

  STUDY DIRECTOR

Central Study Contacts

Tipvilai Taweepunturat, Pharm.D.

CONTACT

0822956659; taribtip@gmail.com

Pasiri Sithinamsuwan, MD

CONTACT

0832367772; pasiripmk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-06

Locations

TH (1)