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Completed

NCT Number: NCT07382843

Melatonin Agonist for Shift-time Workers.

The study of the relationship between sleep pattern, attention performance, and heart rate variability among night workers.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramelteon

Drug

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

Other names: Rozerem

Primary outcomes

  1. 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.

Secondary outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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