Abstract
BACKGROUND: Medical students face a demanding workload, stressful situations, and irregular sleep patterns, which can lead to elevated sleep disturbances and high fatigue levels. These difficulties may be further associated with a major decline in well-being, quality of life, performance, and health. Thus, these struggles must be addressed to reduce these students' sleep disturbances and fatigue during their curriculum. METHODS: The PROMESS-Sleep clinical trial aims to support future healthcare professionals by enhancing their abilities to manage their sleep. The support will be provided through a three-session sleep management program. Each session will include an individual meeting between a PROMESS-Sleep expert and a medical student, during which self-care education, advice, and personalized goals will be established. The present protocol is designed to assess the influence of this program on 45 undergraduate medical students (fourth- and fifth-year) of the Lyon-Est Faculty of Medicine (Claude Bernard University Lyon 1, France). Assessments of sleep and fatigue will be conducted before and during the intervention using self-reported questionnaires and actigraphy. At the end of the third session, the student's satisfaction levels regarding the program will be assessed. The primary outcome will be changes in scores on the Pittsburgh Sleep Quality Index (PSQI) during the program. Secondary outcomes will provide a detailed characterization of changes in various aspects of sleep disturbances, fatigue, sleep habits, and sleep-wake rhythms. Exploratory outcomes will provide information regarding the students' satisfaction levels and will determine the moderators of the program's efficacy. Data will be analyzed according to the intention-to-treat principle and presented in accordance with the CONSORT Guidelines. Ethical approval has been obtained by the Institutional Review Board (IRB: 2023-07-04-03), and all procedures will be performed in adherence to the Helsinki Declaration. The results from this study will be presented at scientific conferences and in peer-reviewed scientific journals. DISCUSSION: The results will provide valuable insights into the program's efficacy in reducing sleep disturbances and fatigue. If its efficacy is proven, PROMESS-Sleep could become an integral and sustainable part of medical education due to fostering a healthier and more resilient future for healthcare professionals. This manuscript follows the SPIRIT guidelines (Additional files 1 & 8). TRIAL REGISTRATION: ClinicalTrials.gov: NCT06297330; retrospectively registered.