Vigilance and Simulated Driving After a Nap

Healthy Volunteers Clinical Trial

— SOMBOX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978026
• Other study ID #: ID RCB 2018-A02253-52
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• -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

Exclusion Criteria:

• participant with a sleep disorder, even if not medicated

• participant with extreme morning or evening chronotype

• pregnancy

• ill or medicated participant

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Behavioral:
• Nap
Each participant is compared to himself in 4 conditions,

Locations

Country	Name	City	State
France	PFRS	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	driving performances	number of lateral deviations of the vehicule	baseline
Primary	sleepiness (vigilance)	Psychomotor vigilance test (PVT)	baseline
Primary	fatigue (vigilance)	Karolinska Sleepiness Scale (KSS),	baseline
Primary	motor coordination (vigilance)	the angle of the steering wheel	baseline
Secondary	sleep	(EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),	baseline
Secondary	temperature	measured each minute with e-tact medical device	baseline
Secondary	heart rate		baseline