HealthyCoEXAMNCT02051647
Copeptin as a Stress Marker During a Written Examination
An observational study of Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
To investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Healthy
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Sep 2014
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: 42 healthy voluntary medical students studying in the 4th year at Basel University
Who may be able to join
- Age over 18 years
- Member of 4th year in medical course at Basel University
Who cannot join
- Intake of any medication (except birth control pill)
- BMI over 30kg/m2
- Evidence of acute disease
- History of chronic illness, including chronic psychiatric disease
- Anamnestic certain or assumed pregnancy
- Regularly smoking students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Copeptin as a Stress Marker During a Written Examination - the CoEXAM
To investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination.
- Conditions
- Healthy
- Keywords
- medical students, Basel University
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in copeptin levels upon examination stress comparing copeptin levels prior and after examination
Measured: 4 hours
Secondary outcomes (2)
Correlation between copeptin levels prior to an exam and exam success
Measured: 4 hours
Correlation to cortisol as the classical stress marker
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051647
- Sponsor's protocol ID
- 325/13
- Acronym
- CoEXAM
- Status last verified
- Dec 2014
- First submitted
- 29 Jan 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Urwyler SA, Schuetz P, Sailer C, Christ-Crain M. Copeptin as a stress marker prior and after a written examination--the CoEXAM study. Stress. 2015 Jan;18(1):134-7. doi: 10.3109/10253890.2014.993966. Epub 2015 Jan 8.
PubMed 25472823
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin as a Stress Marker During a Written Examination - the CoEXAM
- ClinicalTrials.gov ID
- NCT02051647
- Acronym / sponsor ID
- CoEXAM / 325/13
- Conditions
- Healthy
- Keywords
- medical students, Basel University
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
To investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 42 healthy voluntary medical students studying in the 4th year at Basel University
Key inclusion criteria (2 listed)
- Age over 18 years
- Member of 4th year in medical course at Basel University
Key exclusion criteria (6 listed)
- Intake of any medication (except birth control pill)
- BMI over 30kg/m2
- Evidence of acute disease
- History of chronic illness, including chronic psychiatric disease
- Anamnestic certain or assumed pregnancy
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
Change in copeptin levels upon examination stress comparing copeptin levels prior and after examination
Time frame: 4 hours
2 secondary outcomes
Correlation between copeptin levels prior to an exam and exam success
Time frame: 4 hours
Correlation to cortisol as the classical stress marker
Time frame: 4 hours
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 4 Dec 2014.
- Derived from this study: PubMed 25472823Urwyler SA, Schuetz P, Sailer C, Christ-Crain M. Copeptin as a stress marker prior and after a written examination--the CoEXAM study. Stress. 2015 Jan;18(1):134-7. doi: 10.3109/10253890.2014.993966. Epub 2015 Jan 8.
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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.
Mirjam Christ-Crain, Prof. principal investigator
University Hospital, Basel, Switzerland
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 Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 6 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 4 Dec 2014. 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 Switzerland. 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?
Change in copeptin levels upon examination stress comparing copeptin levels prior and after examination (time frame: 4 hours). 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 NCT02051647, which also lists 1 linked publication.
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 4 Dec 2014.