Vigilance and Simulated Driving After a Nap (SOMBOX)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Behavioral: Nap

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • PFRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nap in a bed; the participants take a nap of 30 min in a bed in a bedroom	Behavioral: Nap; Each participant is compared to himself in 4 conditions,
Experimental: nap in an armchair; the participants take a nap of 30 min in a car sit in a bedroom	Behavioral: Nap; Each participant is compared to himself in 4 conditions,
Experimental: nap in teh Sombox; the participants take a nap of 30 min in the micro-hotel Sombox	Behavioral: Nap; Each participant is compared to himself in 4 conditions,
Sham Comparator: no nap in a bed; the participant stay awaked for 30 min in a bed in a bedroom	Behavioral: Nap; Each participant is compared to himself in 4 conditions,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
driving performances	number of lateral deviations of the vehicule	baseline
sleepiness (vigilance)	Psychomotor vigilance test (PVT)	baseline
fatigue (vigilance)	Karolinska Sleepiness Scale (KSS),	baseline
motor coordination (vigilance)	the angle of the steering wheel	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep	(EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),	baseline
temperature	measured each minute with e-tact medical device	baseline
heart rate		baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Chair: Antoine Gauthier, UMR 1075 COMETE

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cognition; driving simulation; vigilance; Nap
• Other Study ID Numbers: ID RCB 2018-A02253-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No