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Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness

Not Applicable
Recruiting
Conditions
Circadian Rhythm Sleep Disorder
Interventions
Behavioral: Chronobiology-guided lifestyle interventions
Registration Number
NCT05569603
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
80
Inclusion Criteria
  1. 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.
  2. Participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months.
  3. Participants must have10 workdays (evening or night shift) within a 14-day period during the study period.
Exclusion Criteria
  1. Active physical diseases.
  2. Moderate to severe psychopathology.
  3. Medications or treatments that may affect sleep.
  4. Pregnant or breastfeeding.
  5. Participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs.
  6. 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chronobiology-guided lifestyle interventions groupChronobiology-guided lifestyle interventionsA multimodal program that includes (1) timed bright light therapy, (2)guidance on meal timing, and (3) sleep hygiene education.
Primary Outcome Measures
NameTimeMethod
insomnia severityThrough 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 Outcome Measures
NameTimeMethod
The neurobehavioral function of cognitive performanceThrough study completion, an average of 14 days

The neurobehavioral function will be evaluated using the Walter Reed Psychomotor Vigilance Test (PVT), a portable reaction-time test based on the Dinges and Powell digital test. The PVT will be testing a 5-min test with responses to randomly spaced stimuli per test.

The processing speed of cognitive performanceThrough study completion, an average of 14 days

A Tablet-based Symbol Digit Modalities Test (T-SDMT) will be used to test processing speed.

The sleepiness at workThrough study completion, an average of 14 days

The Karolinska Sleepiness Scale (KSS) will be used to measure sleepiness at work. It is on a scale of 1 to 9. A higher score is more sleepy.

Trial Locations

Locations (1)

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

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