Vigilance and Simulated Driving After a Nap (SOMBOX)

Caen University Hospital

Status: Completed

Conditions: Healthy Volunteers

Treatments: Behavioral: Nap

Study type: Interventional

Funder types: Other

Identifiers

NCT03978026

ID RCB 2018-A02253-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 4 patient groups

nap in a bed

Experimental group

Description:

the participants take a nap of 30 min in a bed in a bedroom

Treatment:

Behavioral: Nap

nap in an armchair

Experimental group

Description:

the participants take a nap of 30 min in a car sit in a bedroom

Treatment:

Behavioral: Nap

nap in teh Sombox

Experimental group

Description:

the participants take a nap of 30 min in the micro-hotel Sombox

Treatment:

Behavioral: Nap

no nap in a bed

Sham Comparator group

Description:

the participant stay awaked for 30 min in a bed in a bedroom

Treatment:

Behavioral: Nap