NCT05569603

Brief Summary

Poor sleep is closely related to circadian misalignment; shift workers often experience shift work disorder characterized by excessive sleepiness and recurrent shift work schedules-associated insomnia. This study aims to examine the effects of a program of chronobiology-guided lifestyle interventions (CGLI) on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 6, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

2.6 years

First QC Date

September 6, 2021

Last Update Submit

October 4, 2022

Conditions

Circadian Rhythm Sleep Disorder

Keywords

ChonobiologyCognitive performanceInsomniaShift workSleepiness

Outcome Measures

Primary Outcomes (1)

  • insomnia severity

    The Insomnia Severity Index will be used to determine the severity of insomnia. The Insomnia Severity Index with a total score ranging from 0 to 28. A higher Insomnia Severity Index score indicates more severe insomnia.

    Through study completion, an average of 14days

Secondary Outcomes (3)

  • The neurobehavioral function of cognitive performance

    Through study completion, an average of 14 days

  • The processing speed of cognitive performance

    Through study completion, an average of 14 days

  • The sleepiness at work

    Through study completion, an average of 14 days

Study Arms (2)

Chronobiology-guided lifestyle interventions group

EXPERIMENTAL

A multimodal program that includes (1) timed bright light therapy, (2)guidance on meal timing, and (3) sleep hygiene education.

Behavioral: Chronobiology-guided lifestyle interventions

wait-list control group

NO INTERVENTION

The participants in the wait-list group will be told that they are on a waiting list during the first 2 weeks to serve as the no-treatment control. Chronobiology-guided lifestyle interventions will be conducted after the posttest is completed.

Interventions

Chronobiology-guided lifestyle interventionsBEHAVIORAL

1\) timed bright light exposure using blue-enriched white light glasses, 2) recommendations for meal timing, and 3) sleep hygiene education

Chronobiology-guided lifestyle interventions group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged 20 to 60 who work full time as a nurse and work a 3-shift rotation, including day shifts, evening shifts, and night shifts in the most recent 6 months.
  • Participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months.
  • Participants must have10 workdays (evening or night shift) within a 14-day period during the study period.

You may not qualify if:

  • Active physical diseases.
  • Moderate to severe psychopathology.
  • Medications or treatments that may affect sleep.
  • Pregnant or breastfeeding.
  • Participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs.
  • Participants who have been diagnosed with sleep-disordered breathing will be excluded. Sleep-disordered breathing such as obstructive sleep apnea (OSA) will be screened using the snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-BANG) questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11257, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmSleep Initiation and Maintenance DisordersSleepiness

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersSleep Disorders, IntrinsicSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pei-Shan Tsai, Professor

    Taipei Medical University

    STUDY CHAIR

  • Shan-Ying Wu, Master

    Taipei Vetern General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Shan Tsai, Professor

CONTACT

+886227361661ptsai@tmu.edu.tw

Shan-Ying Wu, Master

CONTACT

+886936509952rapport5045@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

October 6, 2022

Study Start

January 12, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)