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临床试验/NCT05096130
NCT05096130撤回不适用

The Effect of Lifestyle Modifications on Aspects Related to Fatigue, Quality of Life, Health, and Sleepiness in Professional Drivers

University of Thessaly2 个研究点 分布在 1 个国家开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Changes in Daily Sleepiness

研究概览

简要总结

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.

详细描述

Methodology Participants: Professional divers with valid 5th category driving license will be the target group of this RCT. All participants will sign an informed consent form in order to participate in the study. Participants will undergo a complete health history and will have the approval of their attending physician. The study has been approved by the local IRB Internal Ethics Committee.

Study Design: This is a randomized clinical trial involving healthy human volunteers. Participants will be assessed before and after a 6-month lifestyle intervention. The current project consists of 9 interconnected Steps:

Step 1: Participants will sign the consent form and complete the PARQ health questionnaire for assessing the readiness to exercise participation followed by the Epworth Sleepiness Scale (SSC) for assessing daily sleepiness.

Step 2: Participants that fulfill the inclusion criteria will be scheduled for a full night Polysomnography test at the sleep unit of the Center of Research and Evaluation of Human Performance (CREHP) laboratory.

Step 3: After completing the polysomnography test, participants will complete a 2h OGTT test for assessing insulin resistance and glucose tolerance. During those two hours, the participants will complete a series of questionnaires assessing aspects related to demographics, quality of life, health, and sleep quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Changes in Daily Sleepiness

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

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.

Changes in Levels fo Fatigue

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

The levels of fatigue will be assessed by the FSS test

Changes in Quality of Sleep

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

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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgos K. Sakkas

Ass Professor

University of Thessaly

研究点 (2)

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