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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05569603
Enrollment
80
Registered
2022-10-06
Start date
2022-01-12
Completion date
2024-07-31
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm Sleep Disorder

Keywords

Chonobiology, Cognitive performance, Insomnia, Shift work, Sleepiness

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.

Interventions

BEHAVIORALChronobiology-guided lifestyle interventions

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

Sponsors

Taipei Medical University
CollaboratorOTHER
Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
insomnia severityThrough study completion, an average of 14daysThe 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

MeasureTime frameDescription
The neurobehavioral function of cognitive performanceThrough study completion, an average of 14 daysThe 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 daysA 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 daysThe 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.

Countries

Taiwan

Contacts

Primary ContactPei-Shan Tsai, Professor
ptsai@tmu.edu.tw+886227361661
Backup ContactShan-Ying Wu, Master
rapport5045@gmail.com+886936509952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026