Sleep for Optimal MEdical StudentS (PROMESS)

NCT06297330 | Recruiting

• 1 other identifier: PROMESS - SLEEP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior; Health-Related Behavior; Sleep; Sleep Disorder; Fatigue

Keywords

Health; Student; Curriculum; Behaviour; Medical; Sleep; Fatigue

Outcome Measures

Primary Outcomes (1)

• Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI).

  The students level of sleep troubles will be assessed through the PSQI score ranging from 0 (none) to 21 (extreme). This score classified the presence or absence of sleep troubles. It can be divided into eight sub-scores (i.e., sleep quality, sleep latency, time spent in bed, sleep time, habitual sleep efficiency, sleep disturbance, use of sleeping medication and daytime dysfunction). The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).

  From week 5 to week 11.

Secondary Outcomes (38)

• Perceived level of sleep troubles. Score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI).

  Week 1 (Pre-intervention)

• Epworth Sleepiness scale. Score obtained at the Epworth Sleepiness scale.

  Week 1 (Pre-intervention)

• Multidimensional Fatigue. Score obtained at the Multidimensional Fatigue Inventory (MFI).

  Week 1 (Pre-intervention)

• Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS).

  Week 1 (Pre-intervention)

• Actimetry records. Time in Bed during the pre-intervention.

  Week 1 (Pre-intervention)

Study Arms (1)

Sleep intervention

EXPERIMENTAL

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

Behavioral: Sleep

Interventions

Sleep 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.

Sleep intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Research on Healthcare Performance Lab U1290: lead

Study Sites (1)

RESHAPE

Lyon, 69008, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39972313 DERIVED

MeSH Terms

Conditions

Health Behavior; Sleep Wake Disorders; Fatigue; Behavior

Interventions

Sleep

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sophie Schlatter, Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Schlatter, Dr.

CONTACT

07 68 21 05 51; sophie.schlatter@univ-lyon1.fr

Angèle Métais, Dr.

CONTACT

06 77 39 89 66; angele.metais@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All volunteers will receive an intervention program based on sleep improvement and fatigue reduction.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: November 11, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-02

Locations

FR (1)