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Clinical Trials/NCT05569603
NCT05569603
Recruiting
Not Applicable

Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness in Female Rotating-shift Nurses: a Randomized Controlled Trial

Taipei Veterans General Hospital, Taiwan1 site in 1 country80 target enrollmentJanuary 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circadian Rhythm Sleep Disorder
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
80
Locations
1
Primary Endpoint
insomnia severity
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Detailed Description

This study will use a parallel-group, randomized, assessor-blind, wait-list controlled design to determine the effects of a program of multimodal lifestyle interventions based on chronobiology, consisting of timed bright light exposure, meal timing manipulations, and sleep hygiene education on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

Registry
clinicaltrials.gov
Start Date
January 12, 2022
End Date
July 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

insomnia severity

Time Frame: Through study completion, an average of 14days

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.

Secondary Outcomes

  • 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 Sites (1)

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