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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05569603
Collaborator
Taipei Medical University (Other), Ministry of Science and Technology, Taiwan (Other)
80
1
2
30.6
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Chronobiology-guided lifestyle interventions
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness in Female Rotating-shift Nurses: a Randomized Controlled Trial
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chronobiology-guided lifestyle interventions group

A multimodal program that includes (1) timed bright light therapy, (2)guidance on meal timing, and (3) sleep hygiene education.

Behavioral: Chronobiology-guided lifestyle interventions
1) timed bright light exposure using blue-enriched white light glasses, 2) recommendations for meal timing, and 3) sleep hygiene education

No Intervention: wait-list control group

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.

Outcome Measures

Primary Outcome Measures

  1. insomnia severity [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 Outcome Measures

  1. The neurobehavioral function of cognitive performance [Through 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.

  2. The processing speed of cognitive performance [Through study completion, an average of 14 days]

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

  3. The sleepiness at work [Through 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Veterans General Hospital Taipei Taiwan 11257

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan
  • Taipei Medical University
  • Ministry of Science and Technology, Taiwan

Investigators

  • Study Chair: Pei-Shan Tsai, Professor, Taipei Medical University
  • Principal Investigator: Shan-Ying Wu, Master, Taipei Vetern General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05569603
Other Study ID Numbers:
  • 2021-06-002A
First Posted:
Oct 6, 2022
Last Update Posted:
Oct 6, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Veterans General Hospital, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2022