Sleep for Optimal MEdical StudentS (PROMESS)

NCT ID: NCT06297330

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-11

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Health Behavior Health-Related Behavior Sleep Sleep Disorder Fatigue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All volunteers will receive an intervention program based on sleep improvement and fatigue reduction.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Sleep intervention

One arm : All volunteers will receive a sleep management intervention.

Group Type EXPERIMENTAL

Sleep

Intervention Type BEHAVIORAL

The sleep management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. 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 these sessions, subjective and objective indicators related to the sleep and fatigue levels will be recorded to assess the progress of each student.

Interventions

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Sleep

The sleep management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. 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 these sessions, subjective and objective indicators related to the sleep and fatigue levels will be recorded to assess the progress of each student.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research on Healthcare Performance Lab U1290

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Schlatter, Dr.

Role: PRINCIPAL_INVESTIGATOR

RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.

Locations

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RESHAPE

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie Schlatter, Dr.

Role: CONTACT

07 68 21 05 51 ext. 33

Angèle Métais, Dr.

Role: CONTACT

06 77 39 89 66 ext. 33

Facility Contacts

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Sophie Schlatter, Dr.

Role: primary

07 68 21 05 51 ext. 33

Angèle Métais, Dr.

Role: backup

06 77 39 89 66 ext. 33

References

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Ruet A, Ndiki Mayi EF, Metais A, Valero B, Henry A, Duclos A, Lilot M, Rode G, Schlatter S. Determining the influence of a sleep improvement intervention on medical students' sleep and fatigue: protocol of the PROMESS-Sleep clinical trial. BMC Med Educ. 2025 Feb 19;25(1):267. doi: 10.1186/s12909-024-06422-x.

Reference Type DERIVED
PMID: 39972313 (View on PubMed)

Other Identifiers

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PROMESS - SLEEP

Identifier Type: -

Identifier Source: org_study_id

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