NCT07382843

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

September 3, 2025

Last Update Submit

January 25, 2026

Conditions

Circadian Rhythm Disorders

Keywords

melatoninchronotype

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Secondary Outcomes (1)

  • Beck Depression Inventory (BDI)

    2 weeks

Study Arms (1)

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.

Drug: Ramelteon

Interventions

RamelteonDRUG

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

Also known as: Rozerem
Ramelteon

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Chronobiology Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Chin-Bin Yeh, M.D., Ph.D.

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor

Study Record Dates

First Submitted

September 3, 2025

First Posted

February 3, 2026

Study Start

March 4, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 3, 2026

Record last verified: 2025-09

Locations

TW(1)