Vigilance and Simulated Driving After a Nap

NCT03978026 | Completed

• 1 other identifier: ID RCB 2018-A02253-52
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Nap; vigilance; cognition; driving simulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• sleep

  baseline

• temperature

  baseline

• heart rate

  baseline

Study Arms (4)

nap in a bed

EXPERIMENTAL

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

Behavioral: Nap

nap in an armchair

EXPERIMENTAL

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

Behavioral: Nap

nap in teh Sombox

EXPERIMENTAL

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

Behavioral: Nap

no nap in a bed

SHAM COMPARATOR

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

Behavioral: Nap

Interventions

Nap BEHAVIORAL

Each participant is compared to himself in 4 conditions,

nap in a bed; nap in an armchair; nap in teh Sombox; no nap in a bed

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• participant with a sleep disorder, even if not medicated
• participant with extreme morning or evening chronotype
• pregnancy
• ill or medicated participant

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

PFRS

Caen, 14000, France

Location

Related Publications (1)

• 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)

  RESULT

Study Officials

• Antoine Gauthier

  UMR 1075 COMETE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be recorded by technicians and results stored anonymously for traitement
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: June 6, 2019
• Study Start: May 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2019
• Last Updated: April 2, 2026

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)