Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05096130 |
| Other study ID # |
1818/09/06/2021 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
University of Thessaly |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Step 4: After the completion of Step 3, participants will go through a body composition
analysis using the DEXA method followed by a bioimpedance analysis for assessing total body
water levels.
Step 5: After the completion of Step 4, participants will participate in a battery of tests
assessing fitness levels and functional capacity. Physical activity levels will be recorded
using a mobile application for the duration of a week.
Step 6: After the completion of Step 5, participants will be scheduled after 2 days for a lab
Multiple Sleep Latency Test (MSLT) for the assessment of their levels of daily sleepiness.
Step 7: After the completion of Step 6, participants will follow a series of interviews with
certified experts. More specifically,
- a registered dietitian will assess nutritional habits and prescribe a corrective diet in
order to improve the participants' nutritional profile.
- a registered psychologist will assess mental health and stress levels and suggest
corrective approaches for improving participants' stress levels and mental capacity.
- a registered exercise physiologist will assess fitness levels and prescribe an
appropriate exercise training program for improving cardiovascular fitness and
functional capacity.
- a registered sleep coach will assess sleep quality and hygiene and suggest ways for
improving sleep quality and restfulness.
Step 8: After completion of Step 7 participants will be given a 24h Blood Pressure (BP)
Holter for assessing the circadian variation of BP and a Heart Rate Variability (HRV) monitor
for assessing HRV during a normal working day (including driving).
Step 9: After the completion of all steps, participants will be randomly assigned to one of
the two groups based on demographic and sleep parameters: the control group (CON) and the
experimental group (EXP).
Intervention: The intervention of the current project includes 6 months of lifestyle
modification counseling based on the guidelines and principles of the European Lifestyle
Medicine Organization (eulm.org). More specifically, counseling will target areas such as
nutrition, exercise, stress, and sleep. A certified specialist will interview and assess all
participants and prescribe the appropriate corrective regimes for improving participants'
lifestyles and reducing cardiovascular risk factors. More particularly, for nutritional
counseling a customized diet will be provided and change every two weeks, for exercise
counseling, a customized supervised exercised training will be provided and change every two
weeks, for psychological counseling, a customized psychological approach will be provided and
reassessed every two weeks and for sleep counseling, a customized sleep hygiene program will
be provided and reevaluated every month.
Randomization: Randomization will take place using a randomization computer software.
Randomization will consider parameters such as gender, age, BMI, and sleepiness score.
Measurements:
Demographic Characteristics: Demographic characteristics include age, gender, race/ethnicity,
education, socioeconomic status, health, disability status, and work-related information.
Questionnaires: Various validated questionnaires will be used for the assessment of aspects
related to the quality of life and health using the interview method.
General Health: The PARQ questionnaire will be used for the assessment of the level of
readiness to participate in an exercise training program. The General Health Questionnaire 30
(GHQ30) will be used for the assessment of the general health status of the participants.
Charlson Comorbidity index will be used for the calculation of the comorbidity index.
Sleepiness and Quality of Sleep: The Epworth Sleepiness Scale (ESS) will be used for the
assessment of the level of sleepiness. The Pittsburgh Sleep Quality Index (PSQI) will be used
for the assessment of sleep quality and sleep abnormalities. Furthermore, the Karolinska
Sleepiness Scale (KSS) will be used for the assessment of alertness and vitality. Finally,
the Daily Sleep Diary will be used for the assessment of the level of sleep quality of the
participants.
Fatigue levels: The Fatigue Severity Scale (FSS) will be used for the assessment of the level
of general fatigue.
The quality of life: The SF36QoL questionnaire (SF-36) will be used for the assessment of the
levels of quality of life.
Depressive symptoms: The Beck Depression Inventory (BDI) questionnaire will be used for the
assessment of depressive symptoms and signs.
Stress: The Perceived Stress Scale (PSS) and the Work Stress Questionnaire (WSQ) will be used
for the assessment of stress levels.
Physical Activity: The International Physical Activity Questionnaire (IPAQ) will be used for
the assessment of physical activity levels.
Driving Skills and Habits: The Driving Habits Questionnaire (DHQ) will be used for the
assessment of driving habits.
Nutrition: The General Nutrition Knowledge Questionnaire (GNKQ) will be used for the
assessment of nutritional knowledge and habits.
Biochemical Analysis: Blood samples will be collected after overnight fasting for measurement
of lipids, hormones, and general hematology analysis. Glucose disposal and indices of insulin
resistance will be assessed by an Oral Glucose Tolerance Test (Blood samples will be
collected 0, 30, 60, 90, and 120 minutes following ingestion of 75gr of glucose). The insulin
resistance index will be calculated by the OGIS and HOMA-IR equations.
Body Composition: Body composition will be assessed using anthropometric measurements
including BMI, WHR as well as DEXA scans for the assessment of total and regional fat and
lean body mass (Lunar model DPX Madison, WI). Intracellular and extracellular as well as
total body water levels will be measured by bioimpedance using a portable BIA system, (Tanita
BC 543).
Blood Pressure: The circadian blood pressure variation will be assessed using a 24h BP Holter
(GIMA 24HABPM).
Heart Rate Variability: Heart Rate Variability will be assessed using a portable ECG designed
to measure all HRV indices (OMRON HCG-801).
Sleep Quality Assessment: Quality and quantity of sleep will be assessed by an overnight
Polysomnographic study (PSG). Levels of daily sleepiness will be assessed using the Multiple
Sleep Latency Test (MSLT). MSLT is a full-day test that consists of five scheduled naps
separated by two-hour breaks.
Fitness Assessment Physical Activity: A mobile phone-based steps tracking application will be
used for the assessment of the weekly physical activity levels.
Aerobic Capacity: The six-minute walk test (6MWT) will be used for the assessment of Aerobic
capacity and Endurance.
Strength: 1RM will be used for the assessment for the evaluation of maximum muscle strength.
Also, the sit to stand-60sec (STS60) test will be used for the assessment for testing leg
strength and endurance. Finally, a 5x sit-to-stand test (STS5) will be used for the
assessment of functional lower extremity strength, transitional movements, balance, and fall
risk.
Flexibility: The Sit and Reach test (S&R) will be used for the assessment of flexibility of
the lower back and hamstring muscles.
Handgrip: The handgrip test will be used for the assessment of the maximum isometric strength
of the hand and for arm muscles (Marsden MG-4800 Hand Dynamometer).
Statistics SPSS statistical software (SPSS 21, Illinois USA) will be used for statistical
analysis.
The pre and post within Control (Con) and Exercise (Ex) groups will be examined by using
paired t-test. Correlations between (Con) group and (Ex) group parameters will be examined by
using Spearman correlation. Also, will be examined Δ change values by using an unpaired
t-test.
Power Analysis:
Power analysis was performed using the open-source software G*Power (3.1.9.2) and was used to
calculate the minimum number of participants required to achieve reasonable power (>85%). A
priori compute required sample size analysis revealed that in one of the main parameters
related to the aims of the study (ESS score), the study needs a total sample size of 42
participants (for both groups) in order to have enough power to detect statistically
significant differences between the pre and post-intervention comparisons (within groups ESS:
Effect size dz=0.4783, total sample size=42, t=2.019, Power (1-β err prob)=0.88289). Given an
estimation of a reasonable dropout rate of 20%, it is estimated that a number of 25
participants per group is needed in order to have significant power to achieve meaningful
results.
