Sleep DeprivationNCT06260280
Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume
An observational study of Sleep Deprivation and Hippocampal Atrophy, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 24 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Hippocampal Atrophy, Cortical Irregularity
- What is being tested?
- Cerebral Nuclear Magnetic Resonance
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 26 Feb 2024to 1 Jun 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All first-year medical residents admitted to our hospital unit who meet the inclusion criteria will be informed of the purpose of the study and, after signing the informed consent, will undergo cranial magnetic resonance imaging.
Who may be able to join
- New resident physicians assigned to the High Specialty Medical Unit, Hospital de Especialidades No. 1 Centro Médico Nacional Del Bajío.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Medica de Alta Especialidad No. 1, Bajío
León, Guanajuato, 37260,
About this study
Official title: Relationship Between Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume Assessed by Nuclear Magnetic Resonance in First-Year Medical Residents
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.
Read the 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.
- Being tested
- Cerebral Nuclear Magnetic Resonance
- Keywords
- Sleep Deprivation, Hippocampal Atrophy, Cortical Irregularity, First-year medical residents
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Nuclear Magnetic ResonanceDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cerebral Nuclear Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start26 Feb 2024 (estimated)
- Primary completion26 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social
- Investigators
- Hilda E Macias, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260280
- Sponsor's protocol ID
- 4
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33827030Craven 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.
PubMed 35708888Perotta 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.
PubMed 33596885Baumann 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.
PubMed 34430893Dai 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.
PubMed 29997530Elvsashagen 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.
PubMed 28526620
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume Assessed by Nuclear Magnetic Resonance in First-Year Medical Residents
- ClinicalTrials.gov ID
- NCT06260280
- Acronym / sponsor ID
- 4
- Keywords
- Sleep Deprivation, Hippocampal Atrophy, Cortical Irregularity, First-year medical residents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 26 Feb 2024 (estimated)
- Primary completion
- 26 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-year medical residents | – | Diagnostic Test: Cerebral Nuclear Magnetic ResonanceAll 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. |
Who may qualify
- Ages
- 24 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All first-year medical residents admitted to our hospital unit who meet the inclusion criteria will be informed of the purpose of the study and, after signing the informed consent, will undergo cranial magnetic resonance imaging.
Key inclusion criteria (1 listed)
- New resident physicians assigned to the High Specialty Medical Unit, Hospital de Especialidades No. 1 Centro Médico Nacional Del Bajío.
Key exclusion criteria (7 listed)
- - 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral Nuclear Magnetic ResonanceCerebral 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. | Diagnostic test | First-year medical residents |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Results publication: PubMed 33827030Mason 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.
- Results publication: PubMed 35708888Craven 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.
- Results publication: PubMed 33596885Perotta 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.
- Results publication: PubMed 34430893Baumann 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.
- Results publication: PubMed 29997530Dai 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.
- Results publication: PubMed 28526620Elvsashagen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilda E Macias, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation and Hippocampal Atrophy, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilda E Macias, PhD (3411152164, liz_2787@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hippocampal volumetry. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260280, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.