The Effect of Caffeinated Chewing Gum on Cognitive Performance in Night-shift Emergency Physicians

NCT06693505 | Completed DMC

• 1 other identifier: Caffeinated Chewing Gum on EP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to examine the impact of caffeinated chewing gum on the cognitive performance of night-shift emergency physicians in a partially sleep-deprived state. A randomized, double-blind crossover controlled experimental design was employed in which fourteen (Age: 29.9 ± 1.44; height: 176.5±5.3; weight: 78.1±13.4) emergency physicians consumed either caffeinated chewing gum (CAF) containing 200 mg caffeine or a caffeine-free placebo gum (PLA) for 10 minutes at 03:30 am during their first 8-hour night shift after at least one day off, and completed cognitive performance tests before shift, mid-shift (10 minutes after gum chewing), and after shift, including included Corsi block test, Task-switching paradigm, Stroop Test, Visual search, and Wisconsin Card Sorting Task. Sleep quality was assessed subjectively by a single question score, and objectively by ActiGraph for one night on the off day and the last sleep before the first night shift, to evaluate the effect of sleep quality on cognitive performance.

Conditions

Cognitive Performance; Sleep Quality

Keywords

night shift worker; sleep deprivation; Reaction time; Stoop test; Visual search; Patient safety

Outcome Measures

Primary Outcomes (5)

• Corsi block test

  There will be 9 purple squares in the screen, when the test starts, it will flash a number of them randomly in yellow color (the more the number increases), then you will hear "Go", then you have to click the order of the flashing ones, and then press "DONE" in the lower right corner. The smiley face means correct, the crying face means wrong. The maximum number of correct answers will be displayed at the end of the test, which is mainly to test the ability of situational awareness and working memory. The whole process takes about 2 minutes.

  baseline (preintervention), immediately after the intervention

• Task-switching paradigm

  There are two shapes (circle, square) and two colors (yellow, blue), four combinations in total. At the beginning of the test, you will see "SHAPE" or "COLOR" (which means that the answer to the question will be based on the shape or color), and then a colorful pattern (e.g., yellow square or blue circle) will appear, then answer the question according to the answer you have just seen (shape or color) as soon as possible. Press B for circles, N for squares, B for yellow, N for blue, and finally the average reaction speed is displayed, which is a test of cognitive structure, flexibility, and plasticity in task processing. The whole test takes about 4 minutes.

  baseline (preintervention), immediately after the intervention

• Stroop Test

  In this quiz, you will see different colors for different words, but all the answers are based on the colors (no matter what the words are). Press R for red, G for green, B for blue, and Y for yellow; for example, if you see "green in red color", you have to press R. The test results comprised a congruent condition, in which the key pressed corresponded correctly to the color on the screen, and an incongruent condition, in which the key pressed corresponded incorrectly to the color name on the screen. At the end of the test, the reaction time will be displayed, which is mainly a test of the ability to inhibit cognitive interference. The whole test takes about 5 minutes.

  baseline (preintervention), immediately after the intervention

• Visual search

  In the visual search test, participants identified orange "T" s on the screen from upside-down orange "T" s, blue "T" s, and upside-down blue "T" s. When an orange "T" would appear, the participants were required to press the spacebar as quickly as possible. If no orange "T" appeared, the participants were required to not react. The test contains 80 search displays, each containing 5, 10, 15 and 20 items, mainly to test the search ability of dynamic vision. Reaction speed was displayed at the end of the test, and the whole test took about 4 minutes.

  baseline (preintervention), immediately after the intervention

• Wisconsin Card Sorting Task

  There is a trial-and-error component to this test. You have to answer the questions first and then determine what the question is based on what is right or wrong. The test is presented in a matching mode, where a pattern on the left is matched with one of the four patterns on the right, and the matching criteria are color, shape, and number. During the test, the questions will be changed from time to time, so if you find out the rules and then suddenly get a question wrong, it means that the question has been changed. The number of errors is displayed at the end of the test to help measure a person's ability to reason abstractly and to change problem-solving strategies when necessary. The entire test lasted about 4 minutes.

  baseline (preintervention), immediately after the intervention

Secondary Outcomes (2)

• subjectively sleep quality

  baseline (the sleep before intervention),the sleep after the intervention

• objectively sleep quality

  baseline (the sleep before intervention),the sleep after the intervention

Study Arms (2)

caffeine trial (CAF)

EXPERIMENTAL

caffeinated chewing gum first, then followed with placebo gum, at least four weeks later Each trial was separated by at least four weeks to avoid interactive effects.

Combination Product: caffeinated chewing gum

placebo trial (PL)

PLACEBO COMPARATOR

placebo gum first, then followed with caffeinated chewing gum, at least 4 weeks later. Each trial was separated by at least four weeks to avoid interactive effects.

Combination Product: placebo

Interventions

caffeinated chewing gum COMBINATION_PRODUCT

two pieces of caffeinated chewing gum at an absolute dose of 200 mg (Military Energy Gum®, Ford Gum and Machine Go, Akron, NY, USA)

caffeine trial (CAF)

placebo COMBINATION_PRODUCT

two pieces of similar looking and tasting placebo gum that did not contain caffeine (xylitol, lime mint, green; Lotte, Saitama, Japan) (PLA trial)

placebo trial (PL)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) healthy male adults, those individuals who are free of pain, insomnia, or other injuries recently, without any medication used in recent 2 months,
• (ii) underwent rotating shifts on the emergency clinical front line with regularly accepted night shift more than two years.

You may not qualify if:

• (i) allergy to caffeine,
• (ii) experience of adverse effects of caffeine,
• (iii) with cardiovascular diseases or any disease that made subjects feel ill.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Deprivation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: A Double-blind Randomized Crossover Controlled Trial

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: October 1, 2022
• Primary Completion: August 25, 2024
• Study Completion: August 31, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after published , for 5 years
• Access Criteria: provide email on published journal, researcher who are interested , could mail to corresponding author and request the data

Locations

TW (1)