SleepSimsleepNCT02922608
French Survey About Student's Sleep Perturbations Before Simulation Session.
An observational study of Sleep and Anxiety, run by Claude Bernard University at 1 site in France.
Trial summary
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants. The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- simulation practice
- How many people
- 1,150 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to 1 Dec 2017
- 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: residents coming to simulation center for high fidelity simulation education program.
Who may be able to join
- french talking residents coming to high fidelity simulation
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French National Investigation About Student's Sleep Perturbations Before Simulation Session.
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.
The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.
Read the detailed description
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.
The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session.
The investigators would like to investigate with a survey how much participants had their quantity and quality of sleep affected before the simulation session.
- Being tested
- simulation practice
- Keywords
- Education, Medical
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation practiceOther
simulation session
What is being measured
The primary outcome is the main question the study is designed to answer.
modification of the sleeping Leeds test
Measured: day 1
Secondary outcomes (2)
incidence of sleep perturbations
Measured: day 1
analysis of demographics and sleep perturbations
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- jean-jacques lehot, PHD, Study chair, Cless
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922608
- Sponsor's protocol ID
- simusleepsurvey
- Acronym
- Simsleep
- Status last verified
- Jan 2018
- First submitted
- 30 Sep 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French National Investigation About Student's Sleep Perturbations Before Simulation Session.
- ClinicalTrials.gov ID
- NCT02922608
- Acronym / sponsor ID
- Simsleep / simusleepsurvey
- Keywords
- Education, Medical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 4 Oct 2016 (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.
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.
The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.
Detailed description
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.
The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session.
The investigators would like to investigate with a survey how much participants had their quantity and quality of sleep affected before the simulation session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- residents coming to simulation center for high fidelity simulation education program.
Key inclusion criteria (1 listed)
- french talking residents coming to high fidelity simulation
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| simulation practicesimulation session | Other | – |
Primary outcome
modification of the sleeping Leeds test
Time frame: day 1
2 secondary outcomes
incidence of sleep perturbations
Time frame: day 1
analysis of demographics and sleep perturbations
Time frame: day 1
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 25 Jan 2018.
- 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.
jean-jacques lehot, PHD study chair
Cless
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 and Anxiety, run by Claude Bernard University at 1 site in France.
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 25 Jan 2018. 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 France. 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?
modification of the sleeping Leeds test (time frame: day 1). 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 25 Jan 2018.