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

Circadian Rhythm Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569603
• Other study ID #: 2021-06-002A
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Pei-Shan Tsai, Professor
• Phone: +886227361661
• Email: ptsai[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders
• Sleepiness

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Ministry of Science and Technology, Taiwan, Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 14days
Secondary	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.	Through study completion, an average of 14 days
Secondary	The processing speed of cognitive performance	A Tablet-based Symbol Digit Modalities Test (T-SDMT) will be used to test processing speed.	Through study completion, an average of 14 days
Secondary	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.	Through study completion, an average of 14 days