SleepPhase 3NCT06496282
Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers
A Phase 3 study testing Lemborexant in people with Sleep, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Lemborexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2024to Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400
Tipvilai Taweepunturat, Pharm.D., 0822956659, taribtip@gmail.com
Pasiri Sithinamsuwan, MD, 0832367772, mailto:pasiripmk@gmail.com
About this study
Official title: 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.
- Conditions
- Sleep
- Being tested
- Lemborexant, Placebo
- Keywords
- Shift workers, Improving sleep, Lemborexant, Orexin receptor antagonists, Hospital rotating shift workers, Rotating shift workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Also called Dayvigo
The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
PlaceboDrug
Also called Dayvigo placebo
The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant 5 mg | Experimental | Lemborexant 5 mg 1 tab hs before bedtime Receives: Drug: Lemborexant |
| Placebo | Placebo comparator | Placebo of Lemborexant 5 mg 1 tab hs before bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Sleepiness level improvement evaluated by physician with Epworth sleepiness scale after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration
Measured: 1 week after screening and 6 weeks after lemborexant administration
Assessment effective of sleep quality in lemborexant 5 mg compare with placebo group
Sleep quality improvement evaluated by physician with Pittsburgh sleep quality index (PSQI) in 1 week after screening and 6 weeks after lemborexant administration
Measured: 1 week after screening and 6 weeks after lemborexant administration
Assessment of depression symptoms in lemborexant 5 mg compare with placebo group
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
Measured: 1 week after screening and 6 weeks after lemborexant administration
Assessment of anxiety symptoms in lemborexant 5 mg compare with placebo group
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
Measured: 1 week after screening and 6 weeks after lemborexant administration
Assessment of cognition in lemborexant 5 mg compare with placebo group
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
Measured: 1 week after screening and 6 weeks after lemborexant administration
Assessment of quality of life in lemborexant 5 mg compare with placebo group
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
Measured: 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
Blood sample of CRP, IL-6 and TNF-alpha changing in 1 week after screening and 6 weeks after lemborexant administration
Measured: 1 week after screening and 6 weeks after lemborexant administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startAug 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Silpakorn University
- Responsible party
- Sponsor
- Investigators
- Tipvilai Taweepunturat, Pharm.D., Study chair, Faculty of Pharmacy Siam UniversityAbisith Dechachongjumroen, MD, Principal investigator, Phramongkutklao hospital and College of MedicineWananwat Danworapong, MD, Principal investigator, Phramongkutklao hospital and College of MedicineJuthathip Suphanklang, BCP, Study director, Phramongkutklao hospital and College of MedicinePasiri Sithinamsuwan, MD, Study director, Phramongkutklao hospital and College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496282
- Sponsor's protocol ID
- LEMY-2024
- Status last verified
- Jun 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lemborexant Versus Placebo on Improving Sleep Quality Among Hospital Rotating Shift Workers: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06496282
- Acronym / sponsor ID
- LEMY-2024
- Conditions
- Sleep
- Keywords
- Shift workers, Improving sleep, Lemborexant, Orexin receptor antagonists, Hospital rotating shift workers, Rotating shift workers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Collaborators
- Silpakorn University
- Study start
- Aug 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lemborexant 5 mg | Experimental | Drug: LemborexantLemborexant 5 mg 1 tab hs before bedtime |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of Lemborexant 5 mg 1 tab hs before bedtime |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LemborexantAlso: DayvigoThe participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study | Drug | Lemborexant 5 mg |
| PlaceboAlso: Dayvigo placeboThe participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study | Drug | Placebo |
Primary outcome
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.
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
7 secondary outcomes
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
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
Assessment of depression symptoms in lemborexant 5 mg compare with placebo group
Time frame: 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
Assessment of cognition in lemborexant 5 mg compare with placebo group
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tipvilai Taweepunturat, Pharm.D. study chair
Faculty of Pharmacy Siam University
Abisith Dechachongjumroen, MD principal investigator
Phramongkutklao hospital and College of Medicine
Wananwat Danworapong, MD principal investigator
Phramongkutklao hospital and College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lemborexant in people with Sleep, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tipvilai Taweepunturat, Pharm.D. (0822956659, taribtip@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.