MedTrace Logo

Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

NCT06496282 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-11

No results posted yet for this study

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

Interventions

DRUG

Lemborexant

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Silpakorn University

    collaborator OTHER

  • Phramongkutklao College of Medicine and Hospital

    lead OTHER

Principal Investigators

  • Tipvilai Taweepunturat, Pharm.D. · Faculty of Pharmacy Siam University

  • Abisith Dechachongjumroen, MD · Phramongkutklao hospital and College of Medicine

  • Wananwat Danworapong, MD · Phramongkutklao hospital and College of Medicine

  • Juthathip Suphanklang, BCP · Phramongkutklao hospital and College of Medicine

  • Pasiri Sithinamsuwan, MD · Phramongkutklao hospital and College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496282 on ClinicalTrials.gov