Vigilance and Simulated Driving After a Nap

NCT ID: NCT03978026

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2019-12-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

nap in a bed

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

Group Type: EXPERIMENTAL

Nap

Intervention Type: BEHAVIORAL

Each participant is compared to himself in 4 conditions,

nap in an armchair

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

Group Type: EXPERIMENTAL

Nap

Intervention Type: BEHAVIORAL

Each participant is compared to himself in 4 conditions,

nap in teh Sombox

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

Group Type: EXPERIMENTAL

Nap

Intervention Type: BEHAVIORAL

Each participant is compared to himself in 4 conditions,

no nap in a bed

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

Group Type: SHAM_COMPARATOR

Nap

Intervention Type: BEHAVIORAL

Each participant is compared to himself in 4 conditions,

Interventions

Nap

Each participant is compared to himself in 4 conditions,

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine Gauthier

Role: STUDY_CHAIR

UMR 1075 COMETE

Locations

PFRS

Caen, , France

Countries

France

Other Identifiers

ID RCB 2018-A02253-52

Identifier Type: -

Identifier Source: org_study_id