Sleep DeprivationNCT04053556
Cognitive Performance After a Night Shift in Internal Medicine Residents
An observational study of Sleep Deprivation and Burnout, Professional, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Burnout, Professional, Cognition Disorders
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 8 Aug 2019to 8 Aug 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Internal Medicine residents in formation who were on the second or third year of the Internal Medicine residency of the Italian Hospital of Buenos Aires who work 24 hours shifts and whose work day continues to a maximum of 36 total hours and who consented to the study.
Who may be able to join
- Internal Medicine residents on the second or third year of formation.
Who cannot join
- Denial to participate in the study or to the informed consent.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires, Peron 4190
Buenos Aires, Buenos Aires F.D., C1199ABB
About this study
Official title: Evaluation on the Effect on Cognition and Emotional Exhaustion With a Change of Long Night Shift System Versus Reduced Night Shift in Residents of Internal Medicine
A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.
Read the detailed description
The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.
A neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.
Auditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).
Results were presented as means of standardized scores (z score) with their interquartile range (IQR).
- Keywords
- sleep deprivation, internal medicine residency, on call, cognitive impairment, burn out, safety, depression
- Medical subject headings
- Sleep Deprivation, Burnout, Professional, Cognition Disorders, Cognitive Dysfunction, Burnout, Psychological, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological evaluation using Paced Auditory Serial Addition Test (PASAT)
Post on-call cognition assessment
Measured: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Burn Out
Maslach questionaire filled by participant
Measured: through study completion, an average of one year
Conners Continuous Performance Test 2 (CPT)
Post on-call attention test
Measured: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Rey auditory verbal learning test (RAVLT)
Post on-call cognition assessment
Measured: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
F-A-S test
Post on-call verbal fluency
Measured: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Direct and indirect digit span
Post on-call short-term verbal memory
Measured: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Secondary outcomes (1)
Depression
Questionaire filled by participant
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start8 Aug 2019
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego H Giunta, MD, Study chair, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053556
- Sponsor's protocol ID
- 2489
- Status last verified
- Aug 2019
- First submitted
- 26 Oct 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Effect on Cognition and Emotional Exhaustion With a Change of Long Night Shift System Versus Reduced Night Shift in Residents of Internal Medicine
- ClinicalTrials.gov ID
- NCT04053556
- Acronym / sponsor ID
- 2489
- Keywords
- sleep deprivation, internal medicine residency, on call, cognitive impairment, burn out, safety, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 12 Aug 2019 (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.
A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.
Detailed description
The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.
A neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.
Auditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).
Results were presented as means of standardized scores (z score) with their interquartile range (IQR).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Internal Medicine residents in formation who were on the second or third year of the Internal Medicine residency of the Italian Hospital of Buenos Aires who work 24 hours shifts and whose work day continues to a maximum of 36 total hours and who consented to the study.
Key inclusion criteria (1 listed)
- Internal Medicine residents on the second or third year of formation.
Key exclusion criteria (1 listed)
- Denial to participate in the study or to the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological evaluation using Paced Auditory Serial Addition Test (PASAT)
Time frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Post on-call cognition assessment
Burn Out
Time frame: through study completion, an average of one year
Maslach questionaire filled by participant
Conners Continuous Performance Test 2 (CPT)
Time frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Post on-call attention test
Rey auditory verbal learning test (RAVLT)
Time frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Post on-call cognition assessment
F-A-S test
Time frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Post on-call verbal fluency
Direct and indirect digit span
Time frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.
Post on-call short-term verbal memory
1 secondary outcome
Depression
Time frame: through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Diego H Giunta, MD study chair
Hospital Italiano de Buenos Aires
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 Burnout, Professional, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 1 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: finished, as of the sponsor's last update on 12 Aug 2019. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological evaluation using Paced Auditory Serial Addition Test (PASAT) (time frame: Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2019.