Healthy VolunteersSOMBOXNCT03978026
Vigilance and Simulated Driving After a Nap
A study testing Nap in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance. This study also aims to record during nap time, sleep, body temperature and heart rate. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 30 Dec 2019
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Male and female participants, aged 20 to 50 years in good health, good sleepers (>8h on average), not being extreme chronotypes, without sleep disorders, healthy, unmedicated, not working in shift work, having been licensed for at least 2 years and driving a minimum of 5000 km per year
- The need for the collection of the signature of informed consent
- The need to be affiliated with the social security system
- The need to understand French
Who cannot join
- participant with a sleep disorder, even if not medicated
- participant with extreme morning or evening chronotype
- pregnancy
- ill or medicated participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de l'efficacité Sur la Vigilance et Les Performances de Conduite simulée d'Une Sieste effectuée Dans Des Environnements différents, Dont le Module SOMBOX
The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance.
This study also aims to record during nap time, sleep, body temperature and heart rate.
Read the detailed description
Nap time is one of the most effective means of combating decreased alertness throughout the day and maintaining cognitive and psychomotor performance.
As such, it is recommended for long-haul drivers driving their vehicle. However, these drivers have no alternative but to sleep in their seats. These conditions are not optimal for producing quality sleep. The motorcyclist, for his part, has no chance of sleeping without finding a place to feel safe to give himself up to sleep. On these bases, SOMBOX has developed a mini-hotel allowing drivers to find an optimized place to take a nap.
Investigators propose an experimental study to evaluate the effectiveness, on simulator driving performance and on the results obtained during cognitive and motor testing, of a nap taken under three different conditions. The effect of the nap will be assessed by comparison to a rest awake.
This study should include healthy volunteer participants.
- Conditions
- Healthy Volunteers
- Being tested
- Nap
- Keywords
- Nap, vigilance, cognition, driving simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapBehavioural
Each participant is compared to himself in 4 conditions,
| Study group | Role | What they receive |
|---|---|---|
| nap in a bed | Experimental | the participants take a nap of 30 min in a bed in a bedroom Receives: Behavioral: Nap |
| nap in an armchair | Experimental | the participants take a nap of 30 min in a car sit in a bedroom Receives: Behavioral: Nap |
| nap in teh Sombox | Experimental | the participants take a nap of 30 min in the micro-hotel Sombox Receives: Behavioral: Nap |
| no nap in a bed | Sham comparator | the participant stay awaked for 30 min in a bed in a bedroom Receives: Behavioral: Nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
driving performances
number of lateral deviations of the vehicule
Measured: baseline
sleepiness (vigilance)
Psychomotor vigilance test (PVT)
Measured: baseline
fatigue (vigilance)
Karolinska Sleepiness Scale (KSS),
Measured: baseline
motor coordination (vigilance)
the angle of the steering wheel
Measured: baseline
Secondary outcomes (3)
sleep
(EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),
Measured: baseline
temperature
measured each minute with e-tact medical device
Measured: baseline
heart rate
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 May 2019
- Primary completion30 Jun 2019
- Study completion30 Dec 2019
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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participant is evaluated in 4 situations : * nap in a bed * nap on a car sit * nap in the Sombox * no nap sitting on a car sit
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Gauthier, Study chair, UMR 1075 COMETE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978026
- Sponsor's protocol ID
- ID RCB 2018-A02253-52
- Acronym
- SOMBOX
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicolas Bessot, Houda Daaloul, Damien Davenne, Antoine Gauthier, Où faire une bonne sieste ?, Volume 7683, Issue 1, 03/2022, Pages 1-70, ISSN 1769-4493, http://dx.doi.org/10.1016/j.msom.2022.01.156 (http://www.sciencedirect.com/science/article/pii/S1769-4493(22)00156-X)
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'efficacité Sur la Vigilance et Les Performances de Conduite simulée d'Une Sieste effectuée Dans Des Environnements différents, Dont le Module SOMBOX
- ClinicalTrials.gov ID
- NCT03978026
- Acronym / sponsor ID
- SOMBOX / ID RCB 2018-A02253-52
- Conditions
- Healthy Volunteers
- Keywords
- Nap, vigilance, cognition, driving simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 6 Jun 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.
The objective of this study is to assess the effectiveness of naps under different environmental conditions and a rest without nap, on driving, alertness and psychomotor performance.
This study also aims to record during nap time, sleep, body temperature and heart rate.
Detailed description
Nap time is one of the most effective means of combating decreased alertness throughout the day and maintaining cognitive and psychomotor performance.
As such, it is recommended for long-haul drivers driving their vehicle. However, these drivers have no alternative but to sleep in their seats. These conditions are not optimal for producing quality sleep. The motorcyclist, for his part, has no chance of sleeping without finding a place to feel safe to give himself up to sleep. On these bases, SOMBOX has developed a mini-hotel allowing drivers to find an optimized place to take a nap.
Investigators propose an experimental study to evaluate the effectiveness, on simulator driving performance and on the results obtained during cognitive and motor testing, of a nap taken under three different conditions. The effect of the nap will be assessed by comparison to a rest awake.
This study should include healthy volunteer participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Participant is evaluated in 4 situations : * nap in a bed * nap on a car sit * nap in the Sombox * no nap sitting on a car sit
| Arm | Type | Receives |
|---|---|---|
| nap in a bed | Experimental | Behavioral: Napthe participants take a nap of 30 min in a bed in a bedroom |
| nap in an armchair | Experimental | Behavioral: Napthe participants take a nap of 30 min in a car sit in a bedroom |
| nap in teh Sombox | Experimental | Behavioral: Napthe participants take a nap of 30 min in the micro-hotel Sombox |
| no nap in a bed | Sham comparator | Behavioral: Napthe participant stay awaked for 30 min in a bed in a bedroom |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- -Male and female participants, aged 20 to 50 years in good health, good sleepers (>8h on average), not being extreme chronotypes, without sleep disorders, healthy, unmedicated, not working in shift work, having been licensed for at least 2 years and driving a minimum of 5000 km per year
- The need for the collection of the signature of informed consent
- The need to be affiliated with the social security system
- The need to understand French
Key exclusion criteria (4 listed)
- participant with a sleep disorder, even if not medicated
- participant with extreme morning or evening chronotype
- pregnancy
- ill or medicated participant
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 |
|---|---|---|
| NapEach participant is compared to himself in 4 conditions, | Behavioural | nap in a bed, nap in an armchair, nap in teh Sombox, no nap in a bed |
Primary outcome
driving performances
Time frame: baseline
number of lateral deviations of the vehicule
sleepiness (vigilance)
Time frame: baseline
Psychomotor vigilance test (PVT)
fatigue (vigilance)
Time frame: baseline
Karolinska Sleepiness Scale (KSS),
motor coordination (vigilance)
Time frame: baseline
the angle of the steering wheel
3 secondary outcomes
sleep
Time frame: baseline
temperature
Time frame: baseline
heart rate
Time frame: baseline
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 2 Apr 2026.
- Results publicationNicolas Bessot, Houda Daaloul, Damien Davenne, Antoine Gauthier, Où faire une bonne sieste ?, Volume 7683, Issue 1, 03/2022, Pages 1-70, ISSN 1769-4493, http://dx.doi.org/10.1016/j.msom.2022.01.156 (http://www.sciencedirect.com/science/article/pii/S1769-4493(22)00156-X)
- 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.
Antoine Gauthier study chair
UMR 1075 COMETE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap in people with Healthy Volunteers, run by University Hospital, Caen 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 4 inclusion and 4 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 2 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
driving performances (time frame: baseline). The study lists 4 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 NCT03978026, 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 2 Apr 2026.