Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

July 3, 2024 updated by: Phramongkutklao College of Medicine and Hospital

The Efficacy of Lemborexant Versus Placebo on Improving Sleep Quality Among Hospital Rotating Shift Workers: A Randomized, Double-Blind, Placebo-Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tipvilai Taweepunturat, Pharm.D.
  • Phone Number: 0822956659
  • Email: taribtip@gmail.com

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Principal Investigator:
          • Pasiri Sithinamsuwan, MD
        • Sub-Investigator:
          • Juthathip Suphanklang, BCP
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tipvilai Taweepunturat, Pharm.D.
        • Principal Investigator:
          • Abisith Dechachongjumroen, MD
        • Principal Investigator:
          • Wananwat Danworapong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lemborexant 5 mg
Lemborexant 5 mg 1 tab hs before bedtime
Drug: Lemborexant
The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
Other Names:
  • Dayvigo
Placebo Comparator: Placebo
Placebo of Lemborexant 5 mg 1 tab hs before bedtime
Drug: Placebo
The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study
Other Names:
  • Dayvigo placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group
Time Frame: 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.
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
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment effective of sleepiness level in lemborexant 5 mg compare with placebo group
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration
Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration
Assessment of depression symptoms in lemborexant 5 mg compare with placebo group
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration
Assessment of anxiety symptoms in lemborexant 5 mg compare with placebo group
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration
Assessment of cognition in lemborexant 5 mg compare with placebo group
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration
Assessment of quality of life in lemborexant 5 mg compare with placebo group
Time Frame: 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
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
Time Frame: 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
1 week after screening and 6 weeks after lemborexant administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Phramongkutklao College of Medicine and Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Silpakorn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Juthathip Suphanklang, BCP, Phramongkutklao Hospital and College of Medicine
  • Study Director: Pasiri Sithinamsuwan, MD, Phramongkutklao Hospital and College of Medicine
  • Study Chair: Tipvilai Taweepunturat, Pharm.D., Faculty of Pharmacy Siam University
  • Principal Investigator: Abisith Dechachongjumroen, MD, Phramongkutklao Hospital and College of Medicine
  • Principal Investigator: Wananwat Danworapong, MD, Phramongkutklao Hospital and College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LEMY-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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