Clinical trial NCT06297330: Sleep for Optimal MEdical StudentS (PROMESS)
Official title: Determining the Influence of an Intervention Program Based on Sleep Improvement and Fatigue Reduction Among Medical Students.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Health-Related Behavior
Sleep
Sleep Disorder
Fatigue
Keywords: Health
Student
Curriculum
Behaviour
Medical
Sleep
Fatigue
Lead sponsor: Research on Healthcare Performance Lab U1290
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All volunteers will receive an intervention program based on sleep improvement and fatigue reduction.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies.

The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students.

Detailed description: Our project aims to help future healthcare professionals to adopt health-promoting behaviors during their studies in a preventive approach. This support will be provided through an intervention program based on sleep improvement and fatigue reduction during their curriculum. Specifically, 4th and 5th-year students at the Faculty of Medicine of Lyon Est will have the opportunity to participate in the PROMESS SLEEP project. This intervention will span 11 weeks. At the end of this period, we expect improvements in both subjective and objective indicators of sleep and fatigue.

METHODS.

PRE-INTERVENTION. Week 1-3. Students will undergo a two-hour session, during which, they will complete questionnaires on sleep and fatigue. Then, they will wear actimeters to monitor sleep during three weeks.

INTERVENTION. From week 5 to week 11. The intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. Each session includes individual interview between a sleep expert and the participant (i.e.student).The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During the interview, the expert will realize an initial assessment of student sleep and fatigue levels and will give personalized goals to student. Subsequent sessions follow the same structure.

Eligibility criteria: Inclusion Criteria:

* Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024.
* Having read the information note.
* Having signed the written consent.

Exclusion Criteria: No exclusion criteria will be applied.

Primary outcomes:
measure: Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI).
timeFrame: From week 5 to week 11.
Secondary outcomes:
measure: Perceived level of sleep troubles. Score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI).
timeFrame: Week 1 (Pre-intervention)
measure: Epworth Sleepiness scale. Score obtained at the Epworth Sleepiness scale.
timeFrame: Week 1 (Pre-intervention)
measure: Multidimensional Fatigue. Score obtained at the Multidimensional Fatigue Inventory (MFI).
timeFrame: Week 1 (Pre-intervention)
measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS).
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Time in Bed during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Total sleep duration during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Sleep efficiency during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Sleep Onset Latency during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Wake after Sleep Onset during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Number of Awakenings during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Bedtime during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Mid-sleep point during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Sleep Onset time during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Sleep Inertia during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Wake-up time during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Actimetry records. Sleep regularity index during the pre-intervention.
timeFrame: Week 1 (Pre-intervention)
measure: Multidimensional Fatigue. Evolution of the score obtained at the Multidimensional Fatigue Inventory (MFI) during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Time in Bed during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Total sleep duration during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Sleep efficiency during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Sleep Onset Latency during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Wake after Sleep Onset during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Number of Awakenings during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Mid-sleep point during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Bed time during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Sleep Onset Time during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Sleep Inertia during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Wake-up Time during the intervention.
timeFrame: From week 5 to week 11.
measure: Actimetry records. Evolution in Sleep regularity index during the intervention.
timeFrame: From week 5 to week 11.
measure: VAS - sleep quantity: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep.
timeFrame: From week 5 to week 11.
measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality.
timeFrame: From week 5 to week 11.
measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue.
timeFrame: From week 5 to week 11.
measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert.
timeFrame: From week 5 to week 11.
measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set.
timeFrame: From week 7 to week 11.
measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention.
timeFrame: From week 5 to week 11.
measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5.
timeFrame: From week 5 to week 11.
measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress.
timeFrame: Week 9-10-11
measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention.
timeFrame: Week 9-10-11
Other outcomes:
Locations:
city: Lyon
country: France
facility: RESHAPE
Study officials:
affiliation: RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
name: Sophie Schlatter, Dr.
role: PRINCIPAL_INVESTIGATOR
References: