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

T

Taipei Veterans General Hospital

Status

Enrolling

Conditions

Circadian Rhythm Sleep Disorder

Treatments

Behavioral: Chronobiology-guided lifestyle interventions

Study type

Interventional

Funder types

Other

Identifiers

NCT05569603
2021-06-002A

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Chronobiology-guided lifestyle interventions group
Experimental group
Description:
A multimodal program that includes (1) timed bright light therapy, (2)guidance on meal timing, and (3) sleep hygiene education.
Treatment:
Behavioral: Chronobiology-guided lifestyle interventions
wait-list control group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Pei-Shan Tsai, Professor; Shan-Ying Wu, Master

Data sourced from clinicaltrials.gov

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