- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260280
Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume
Relationship Between Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume Assessed by Nuclear Magnetic Resonance in First-Year Medical Residents
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hilda E Macias, PhD
- Phone Number: 3411152164
- Email: liz_2787@hotmail.com
Study Locations
-
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Guanajuato
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Leon, Guanajuato, Mexico, 37260,
- Unidad Medica de Alta Especialidad No. 1, Bajío
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
First-year medical residents
All first-year residents entering our department for any of the different specialties will undergo a nuclear magnetic resonance scan before starting their shifts and a control scan 2 months into their residency to evaluate if there is an association between chronic sleep deprivation and changes in cortical and hippocampal volume.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hippocampal volumetry.
Time Frame: 2 months
|
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
|
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Change in cortical volumetry
Time Frame: 2 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hilda E Macias, PhD, Instituto Mexicano del Seguro Social
Publications and helpful links
General Publications
- 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.
- 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 Jun 16.
- 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. 2021 Feb 17;21(1):111. doi: 10.1186/s12909-021-02544-8.
- 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 Aug.
- 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.
- 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;156:214-223. doi: 10.1016/j.neuroimage.2017.05.027. Epub 2017 May 17.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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