Back to resultsEffects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness
Primary Purpose
Circadian Rhythm Sleep Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chronobiology-guided lifestyle interventions
Sponsored by
About this trial
This is an interventional other trial for Circadian Rhythm Sleep Disorder focused on measuring Chonobiology, Cognitive performance, Insomnia, Shift work, Sleepiness
Eligibility Criteria
Inclusion Criteria:
- 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.
- Participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months.
- Participants must have10 workdays (evening or night shift) within a 14-day period during the study period.
Exclusion Criteria:
- Active physical diseases.
- Moderate to severe psychopathology.
- Medications or treatments that may affect sleep.
- Pregnant or breastfeeding.
- Participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs.
- 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.
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chronobiology-guided lifestyle interventions group
wait-list control group
Arm Description
A multimodal program that includes (1) timed bright light therapy, (2)guidance on meal timing, and (3) sleep hygiene education.
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.
Outcomes
Primary Outcome Measures
insomnia severity
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
The neurobehavioral function of cognitive performance
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.
The processing speed of cognitive performance
A Tablet-based Symbol Digit Modalities Test (T-SDMT) will be used to test processing speed.
The sleepiness at work
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.
Full Information
NCT ID
NCT05569603
First Posted
September 6, 2021
Last Updated
October 4, 2022
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Taipei Medical University, Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05569603
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Taipei Medical University, Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Sleep Disorder
Keywords
Chonobiology, Cognitive performance, Insomnia, Shift work, Sleepiness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronobiology-guided lifestyle interventions group
Arm Type
Experimental
Arm Description
A multimodal program that includes (1) timed bright light therapy, (2)guidance on meal timing, and (3) sleep hygiene education.
Arm Title
wait-list control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Chronobiology-guided lifestyle interventions
Intervention Description
1) timed bright light exposure using blue-enriched white light glasses, 2) recommendations for meal timing, and 3) sleep hygiene education
Primary Outcome Measure Information:
Title
insomnia severity
Description
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.
Time Frame
Through study completion, an average of 14days
Secondary Outcome Measure Information:
Title
The neurobehavioral function of cognitive performance
Description
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.
Time Frame
Through study completion, an average of 14 days
Title
The processing speed of cognitive performance
Description
A Tablet-based Symbol Digit Modalities Test (T-SDMT) will be used to test processing speed.
Time Frame
Through study completion, an average of 14 days
Title
The sleepiness at work
Description
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.
Time Frame
Through study completion, an average of 14 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months.
Participants must have10 workdays (evening or night shift) within a 14-day period during the study period.
Exclusion Criteria:
Active physical diseases.
Moderate to severe psychopathology.
Medications or treatments that may affect sleep.
Pregnant or breastfeeding.
Participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Shan Tsai, Professor
Phone
+886227361661
Ext
2693
Email
ptsai@tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Shan-Ying Wu, Master
Phone
+886936509952
Email
rapport5045@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Shan Tsai, Professor
Organizational Affiliation
Taipei Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shan-Ying Wu, Master
Organizational Affiliation
Taipei Vetern General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11257
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan-Ying Wu, Master
Phone
886936509952
Email
rapport5045@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness
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