WithdrawnNot Applicable

Lifestyle Medicine Strategies for Combating Sleepiness and Fatigue in Professional Drivers

Stopped: Recruitment difficulties

Greece0Started 2021-09-01

Plain-language 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.

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Daily Sleepiness

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

Changes in Levels fo Fatigue

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

Changes in Quality of Sleep

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

Trial details

NCT IDNCT05096130

SponsorUniversity of Thessaly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01

View on ClinicalTrials.gov More Sleepiness, Daytime trials

Plain-language summary

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.