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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06260280
Other study ID # 4
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 26, 2024
Est. completion date June 1, 2024

Study information

Verified date February 2024
Source Instituto Mexicano del Seguro Social
Contact Hilda E Macias, PhD
Phone 3411152164
Email liz_2787@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Sleep is a physiological state that is essential for human performance, including academic, occupational, interpersonal, and psychological aspects. Sleep disruption or deprivation leads to a loss of psychomotor skills and an increased association with various diseases. Therefore, it is critical to assess how chronic sleep deprivation affects medical residents who work long shifts, including those assigned during their training.


Description:

Objective: To determine if there is an association between chronic sleep deprivation and changes in cortical and hippocampal volume, assessed by nuclear magnetic resonance, in first-year medical residents assigned to the High Specialty Medical Unit, Specialty Hospital No. 1, National Medical Center of Bajío, during a period of 2 months after their admission. Materials and Methods: This is a retrospective cohort study of first-year residents at UMAE T1, with a calculated sample size of 37 patients. Results are presented using descriptive statistics with mean and standard deviation or median with confidence intervals, depending on the type of variable. The relationship between MRI values and sleep deprivation will be assessed using Pearson's correlation coefficient or its non-parametric equivalent. Ethical considerations: The study will be conducted with the informed consent of the patients in accordance with the General Health Law on Research and the Helsinki Declaration of 1975. The risk associated with this study is more than minimal. Resources: Magnetic resonance studies will be performed at the High Specialty Medical Unit, Specialty Hospital No. 1, National Medical Center of Bajio, under the supervision of affiliated physicians specializing in the field of radiology and a fourth year resident in Diagnostic and Therapeutic Imaging.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 37
Est. completion date June 1, 2024
Est. primary completion date May 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 30 Years
Eligibility Inclusion Criteria: - New resident physicians assigned to the High Specialty Medical Unit, Hospital de Especialidades No. 1 Centro Médico Nacional Del Bajío. Exclusion Criteria: - - Patients who have ingested caffeine, nicotine or alcohol in the last 24 hours. - Patients with sleep disorders who present a score greater than 5 in the initial assessment of the Pittsburgh Sleep Quality Index. - Patients with psychiatric treatment. - Patients ingesting medications that intervene in the awake state. - Patients with drug abuse (marijuana, cocaine, etc.). - Patients with claustrophobia. - Patients with metallic implants.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cerebral Nuclear Magnetic Resonance
Cerebral Nuclear Magnetic Resonance before the start of the shifts and a control 2 months after the start of the residency to evaluate if there is an association between chronic sleep deprivation and changes in cortical and hippocampal volume.

Locations

Country Name City State
Mexico Unidad Medica de Alta Especialidad No. 1, Bajío Leon Guanajuato

Sponsors (1)

Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Baumann Q, Bulaid Y, Van Vliet A, Gabrion A, Klein C, Mertl P. Sleep Deprivation Adversely Impacts Resident Performance for Simulated Arthroscopy. Arthrosc Sports Med Rehabil. 2021 Jul 9;3(4):e1125-e1132. doi: 10.1016/j.asmr.2021.04.001. eCollection 2021 — View Citation

Craven J, McCartney D, Desbrow B, Sabapathy S, Bellinger P, Roberts L, Irwin C. Effects of Acute Sleep Loss on Physical Performance: A Systematic and Meta-Analytical Review. Sports Med. 2022 Nov;52(11):2669-2690. doi: 10.1007/s40279-022-01706-y. Epub 2022 — View Citation

Dai XJ, Jiang J, Zhang Z, Nie X, Liu BX, Pei L, Gong H, Hu J, Lu G, Zhan Y. Plasticity and Susceptibility of Brain Morphometry Alterations to Insufficient Sleep. Front Psychiatry. 2018 Jun 27;9:266. doi: 10.3389/fpsyt.2018.00266. eCollection 2018. — View Citation

Elvsashagen T, Zak N, Norbom LB, Pedersen PO, Quraishi SH, Bjornerud A, Alnaes D, Doan NT, Malt UF, Groote IR, Westlye LT. Evidence for cortical structural plasticity in humans after a day of waking and sleep deprivation. Neuroimage. 2017 Aug 1;156:214-22 — View Citation

Mason GM, Lokhandwala S, Riggins T, Spencer RMC. Sleep and human cognitive development. Sleep Med Rev. 2021 Jun;57:101472. doi: 10.1016/j.smrv.2021.101472. Epub 2021 Mar 13. — View Citation

Perotta B, Arantes-Costa FM, Enns SC, Figueiro-Filho EA, Paro H, Santos IS, Lorenzi-Filho G, Martins MA, Tempski PZ. Sleepiness, sleep deprivation, quality of life, mental symptoms and perception of academic environment in medical students. BMC Med Educ. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hippocampal volumetry. The hippocampal volume is obtained using the three planes of visualization of T1-weighted images in volumetric sequences. Volumetric analysis will be performed using volBrain and will be reported in cm3. 2 months
Primary Change in cortical volumetry The cortical volume is obtained using the three planes of visualization of T1-weighted images in volumetric sequences. Volumetric analysis will be performed using volBrain and will be reported in cm3. 2 months
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