Lifestyle Medicine Strategies for Combating Sleepiness and Fatigue in Professional Drivers

NCT05096130 | Withdrawn DMC

• 1 other identifier: 1818/09/06/2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep has a number of health benefits, including memory and learning, vitality and energy as well as high quality of life levels. Lack of sleep impairs judgment, impacts longevity and safety, and increases the risk of a number of diseases including obesity, hypertension, heart disease, diabetes, mood disorders, and impaired immune function. In addition lack of sleep or disturbance of normal sleep cycle could have a major impact on people's lives and working performance such as driving. Daily sleepiness is a problem concerning professions with a non-fixed schedule. Specifically, professional long-haul drivers confront sleepiness problems and in combination with fatigue, they are prone to driving accidents and other incidents. Sleep quality and quantity are closed related to fatigue which is one of the most common reasons for driving and working accidents. In recent years, car accidents involving professional drives have increased significantly. The main reasons for those accidents were fatigue and sleepiness due to long hours of driving or difficult working conditions according to the recent European report (Driver Fatigue in European Road Transport - etf-europe.org). Lifestyle Medicine addresses health risk factors in primary, secondary, and tertiary prevention of developing disease rather than on acute care and reacting to illness, injury, and disease. Lifestyle Medicine strategies targeting modifiable risk factors, such as diet, sleep, stress, and physical activity. By applying those regimes the investigators could improve physical and mental health levels that can affect the quality of sleep, reducing daily sleepiness and fatigue, in professional drivers operating coaches and trucks. Any intervention that could improve alertness and reduce fatigue and sleepiness in those people, will automatically improve safety, reduce driving accidents and save lives and resources.

Conditions

Sleepiness, Daytime; Fatigue; Sleep Disorders, Circadian Rhythm

Keywords

driving; lifestyle medicine; Quality of life; Physical Activity; Diet; stress; sleep coaching; road accidents

Outcome Measures

Primary Outcomes (3)

• Changes in Daily Sleepiness

  The levels of daily sleepiness will be assessed by a Multiple Sleep Latency Test (MSLT). This is the gold standard approach for assessing daily sleepiness.

  Assessed at 0-month (pre) and at 6-month (post)

• Changes in Levels fo Fatigue

  The levels of fatigue will be assessed by the FSS test

  Assessed at 0-month (pre) and at 6-month (post)

• Changes in Quality of Sleep

  Quality of sleep will be assessed by a full night polysomnography study

  Assessed at 0-month (pre) and at 6-month (post)

Secondary Outcomes (4)

• Changes in Body composition

  Assessed at 0-month (pre) and at 6-month (post)

• Changes in Exercise Capacity

  Assessed at 0-month (pre) and at 6-month (post)

• Changes in Stress levels Work Stress Questionnaire

  Assessed at 0-month (pre) and at 6-month (post)

• Changes in Quality of Life levels

  Assessed at 0-month (pre) and at 6-month (post)

Study Arms (2)

Control Group - No intervention

NO INTERVENTION

The control group will not participate in any intervention for the duration of the study. In addition, the participants will be instructed to follow their usual daily schedule for 6 months. Changes in health, medication, or habits will be discussed by the investigators' team and reassess the continuation or the termination of the investigated participant.

Lifestyle Medicine Strategies Groupo

EXPERIMENTAL

The LSM (LifeStyle Medicine) group, will receive a 6-month lifestyle change intervention targeting the correction of diet, improving physical activity and exercise levels, reducing stress levels, and improving sleep hygiene by LSM registered professionals.

Behavioral: Lifestyle Medicine Strategies

Interventions

Lifestyle Medicine Strategies BEHAVIORAL

LM addresses health risk factors in primary, secondary, and tertiary prevention of developing disease rather than limiting resources and medical expenditures on acute care and reacting to illness, injury, and disease. The intervention will target the four pillars of the LM approach including physical activity, diet, stress, and sleep. Certified in LM strategies professionals will consult participants from the LM group in a biweekly base in order to improve their lifestyle habits.

Lifestyle Medicine Strategies Groupo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both sexes,
• age between 25 and 60 yrs old
• valid 5th category driving license for large trucks and coaches
• minimum of 3 years of continuous and verifiable documented work experience as a professional driver in the past 5 years
• diagnosed with moderate daily sleepiness as this is documented by a value \>9 in Epworth Sleepiness Scale (SSC)

You may not qualify if:

• drivers with a driving license that expires within a year of the recruitment date,
• disabilities that prevent them from walking independently or exercising,
• verified mental illnesses,
• alcoholism or drug abuses,
• or conditions that could affect the outcome of the study

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Lifestlye Medicine Laboratory, TEFAA, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Fatigue; Sleep Disorders, Circadian Rhythm; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronobiology Disorders; Occupational Diseases; Behavior

Study Officials

• Giorgos K Sakkas, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

• Efthmios Dardiotis, MD, PhD

  University of Thessaly

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Parameters such as questionnaires' scores, polysomnography outcomes, indices of health, and other data will be masked and coded for blind analysis by the main investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Professor

Model Details: This is a randomized controlled trial. The study is composed of two groups. Group 1 is the control group and Group 2 is the experimental one. The trial period will last for 6 months for both groups. Intervention includes lifestyle changes targeting physical activity, diet, stress and sleep quality. The design is parallel.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 27, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 31, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)