Clinical trial NCT05569603: Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness
Official title: Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness in Female Rotating-shift Nurses: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circadian Rhythm Sleep Disorder
Keywords: Chonobiology
Cognitive performance
Insomnia
Shift work
Sleepiness
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Taipei Medical University
name: Ministry of Science and Technology, Taiwan
First posted: 2022-10-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: insomnia severity
timeFrame: Through study completion, an average of 14days
Secondary outcomes:
measure: The neurobehavioral function of cognitive performance
timeFrame: Through study completion, an average of 14 days
measure: The processing speed of cognitive performance
timeFrame: Through study completion, an average of 14 days
measure: The sleepiness at work
timeFrame: Through study completion, an average of 14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Medical University
name: Pei-Shan Tsai, Professor
role: STUDY_CHAIR
affiliation: Taipei Vetern General Hospital
name: Shan-Ying Wu, Master
role: PRINCIPAL_INVESTIGATOR
References: