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Vigilance and Simulated Driving After a Nap (SOMBOX)

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ClinicalTrials.gov Identifier: NCT03978026
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Behavioral: Nap Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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
Masking: Single (Investigator)
Masking Description: Participants will be recorded by technicians and results stored anonymously for traitement
Primary Purpose: Basic Science
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

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,




Primary Outcome Measures :
  1. driving performances [ Time Frame: baseline ]
    number of lateral deviations of the vehicule

  2. sleepiness (vigilance) [ Time Frame: baseline ]
    Psychomotor vigilance test (PVT)

  3. fatigue (vigilance) [ Time Frame: baseline ]
    Karolinska Sleepiness Scale (KSS),

  4. motor coordination (vigilance) [ Time Frame: baseline ]
    the angle of the steering wheel


Secondary Outcome Measures :
  1. sleep [ Time Frame: baseline ]
    (EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),

  2. temperature [ Time Frame: baseline ]
    measured each minute with e-tact medical device

  3. heart rate [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978026


Contacts
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Contact: Damien Davenne, HDR 33 6 87 98 42 65 damien.davenne@unicaen.fr
Contact: Hervé Normand, MD/PhD herve.normand@unicaen.fr

Locations
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France
PFRS Recruiting
Caen, France, 14000
Contact: Damien Davenne, HDR    33 6 87 98 42 65    damien.davenne@unicaen.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Study Chair: Antoine Gauthier UMR 1075 COMETE

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03978026     History of Changes
Other Study ID Numbers: ID RCB 2018-A02253-52
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Nap
vigilance
cognition
driving simulation