Circadian Rhythm DisordersPhase 4NCT07382843
Melatonin Agonist for Shift-time Workers.
A Phase 4 study testing Ramelteon in people with Circadian Rhythm Disorders, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The study of the relationship between sleep pattern, attention performance, and heart rate variability among night workers. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Circadian Rhythm Disorders
- What is being tested?
- Ramelteon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2024to 31 Dec 2025
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The individuals aged 20-55 who are night workers whose working hours more than 4 hours duration between 22:00 to 06:00.
- Meet the DSM-5 diagnostic criteria of this Circadian Rhythm Sleep Wake Disorders.
Who cannot join
- The individuals could not understand the online questionnaires and is not willing to fill out questionnaires.
- The individual is not willing to have supplement with melatonin.
- Not willing to have prescription with melatonin agonist ramelteon.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center
Taipei, 114
About this study
Official title: The Study of the Relationship Between Sleep Pattern, Attention Performance, and Heart Rate Variability Among Night Workers.
The study of the relationship between sleep pattern, attention performance, and heart rate variability among night workers.
Read the detailed description
Background: Previous study found that sleeping in the morning or evening pattern might be associated with performance among night workers. Both their sleep quality and circadian rhythm are critical for the performance at night. The study aims to identify the association between sleep pattern and performance among night workers. The effectiveness of interventions either supplement with melatonin for those who not meeting the DSM-5 criteria of Circadian Rhythm Sleep-Wake Disorders, CRSWD and prescription of melatonin agonist ramelteon for those who meet the DSM-5 criteria of CRSWD will be evaluated.
Methods:
The investigators will prescribe melatonin agonist ramelteon for 80 subjects those who agree to participate and meet the DSM-5 diagnostic criteria of this Circadian Rhythm Sleep Wake Disorders. They will receive the assessments including questionnaires and performance measurements before and after prescription with melatonin agonist 8 mg for 2 weeks to investigate the effectiveness of melatonin agonist.
Anticipated outcome: The study will help the understanding the association of sleep pattern and performance among night workers. The effectiveness of either supplement with melatonin and prescription of melatonin agonist will be evaluated. The findings of our study might be implicated in the plans of intervention for better performance for night warriors.
- Conditions
- Circadian Rhythm Disorders
- Being tested
- Ramelteon
- Keywords
- melatonin, chronotype
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
comparison of anxiety/depression, insomnia symptoms severity between before and after treatment with 8mg Ramelteon per day for two weeks among shift time workers.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon | Other | comparison of anxiety/depression, insomnia symptoms severity between before and after treatment with 8mg Ramelteon per day for two weeks among shift time workers. Receives: Drug: Ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index (PSQI）
The investigators will measure if the severity improve after using Somn Well XR and Rozerem by the PSQI scale.
The cutoff score for the cutoff score for the Pittsburgh Sleep Quality Index (PSQI) questionnaire is 5. Higher scores on both questionnaires indicate a greater severity of sleep issues.
Measured: 2 weeks
Secondary outcomes (1)
Beck Depression Inventory (BDI)
The investigators will measure if the severity improve after using Somn Well XR and Rozerem by the BDI scale.
The cutoff score for the Beck Depression Inventory (BDI) questionnaire is 13. Higher scores on both questionnaires indicate greater severity of depressive and anxiety symptoms.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start4 Mar 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital (TSGH)
- Investigators
- Chin-Bin Yeh, M.D., Ph.D., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382843
- Sponsor's protocol ID
- C202205038
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 3 Feb 2026
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Relationship Between Sleep Pattern, Attention Performance, and Heart Rate Variability Among Night Workers.
- ClinicalTrials.gov ID
- NCT07382843
- Acronym / sponsor ID
- C202205038
- Conditions
- Circadian Rhythm Disorders
- Keywords
- melatonin, chronotype
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Feb 2026 (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.
The study of the relationship between sleep pattern, attention performance, and heart rate variability among night workers.
Detailed description
Background: Previous study found that sleeping in the morning or evening pattern might be associated with performance among night workers. Both their sleep quality and circadian rhythm are critical for the performance at night. The study aims to identify the association between sleep pattern and performance among night workers. The effectiveness of interventions either supplement with melatonin for those who not meeting the DSM-5 criteria of Circadian Rhythm Sleep-Wake Disorders, CRSWD and prescription of melatonin agonist ramelteon for those who meet the DSM-5 criteria of CRSWD will be evaluated.
Methods:
The investigators will prescribe melatonin agonist ramelteon for 80 subjects those who agree to participate and meet the DSM-5 diagnostic criteria of this Circadian Rhythm Sleep Wake Disorders. They will receive the assessments including questionnaires and performance measurements before and after prescription with melatonin agonist 8 mg for 2 weeks to investigate the effectiveness of melatonin agonist.
Anticipated outcome: The study will help the understanding the association of sleep pattern and performance among night workers. The effectiveness of either supplement with melatonin and prescription of melatonin agonist will be evaluated. The findings of our study might be implicated in the plans of intervention for better performance for night warriors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon | Other | Drug: Ramelteoncomparison of anxiety/depression, insomnia symptoms severity between before and after treatment with 8mg Ramelteon per day for two weeks among shift time workers. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The individuals aged 20-55 who are night workers whose working hours more than 4 hours duration between 22:00 to 06:00.
- Meet the DSM-5 diagnostic criteria of this Circadian Rhythm Sleep Wake Disorders.
Key exclusion criteria (3 listed)
- The individuals could not understand the online questionnaires and is not willing to fill out questionnaires.
- The individual is not willing to have supplement with melatonin.
- Not willing to have prescription with melatonin agonist ramelteon.
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 |
|---|---|---|
| RamelteonAlso: Rozeremcomparison of anxiety/depression, insomnia symptoms severity between before and after treatment with 8mg Ramelteon per day for two weeks among shift time workers. | Drug | Ramelteon |
Primary outcome
Pittsburgh sleep quality index (PSQI）
Time frame: 2 weeks
The investigators will measure if the severity improve after using Somn Well XR and Rozerem by the PSQI scale. The cutoff score for the cutoff score for the Pittsburgh Sleep Quality Index (PSQI) questionnaire is 5. Higher scores on both questionnaires indicate a greater severity of sleep issues.
1 secondary outcome
Beck Depression Inventory (BDI)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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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.
Chin-Bin Yeh, M.D., Ph.D. principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Circadian Rhythm Disorders, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 3 Feb 2026. 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 Taiwan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (PSQI） (time frame: 2 weeks). 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 3 Feb 2026.