Melatonin Agonist for Shift-time Workers.

Tri-Service General Hospital

Status and phase: Completed; Phase 4

Conditions: Circadian Rhythm Disorders

Treatments: Drug: Ramelteon

Study type: Interventional

Funder types: Other

Identifiers

NCT07382843

C202205038

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Ramelteon

Other group

Description:

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

Treatment:

Drug: Ramelteon