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

October 4, 2022 updated by: Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pei-Shan Tsai, Professor
  • Phone Number: 2693 +886227361661
  • Email: ptsai@tmu.edu.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11257
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insomnia severity
Time Frame: 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.
Through study completion, an average of 14days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The neurobehavioral function of cognitive performance
Time Frame: 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.
Through study completion, an average of 14 days
The processing speed of cognitive performance
Time Frame: Through study completion, an average of 14 days
A Tablet-based Symbol Digit Modalities Test (T-SDMT) will be used to test processing speed.
Through study completion, an average of 14 days
The sleepiness at work
Time Frame: 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.
Through study completion, an average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-06-002A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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