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Melatonin Agonist for Shift-time Workers.

The Study of the Relationship Between Sleep Pattern, Attention Performance, and Heart Rate Variability Among Night Workers.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07382843
Enrollment
61
Registered
2026-02-03
Start date
2024-03-04
Completion date
2025-12-31
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm Disorders

Keywords

melatonin, chronotype

Brief summary

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.

Interventions

DRUGRamelteon

comparison of anxiety/depression, insomnia symptoms severity between before and after treatment with 8mg Ramelteon per day for two weeks among shift time workers.

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh sleep quality index (PSQI)2 weeksThe 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.

Secondary

MeasureTime frameDescription
Beck Depression Inventory (BDI)2 weeksThe 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.

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORChin-Bin Yeh, M.D., Ph.D.

Tri-Service General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026