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出境医 / 临床实验 / Vigilance and Simulated Driving After a Nap (SOMBOX)

Vigilance and Simulated Driving After a Nap (SOMBOX)

Study Description
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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 30, 2019
Arms and Interventions
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,
Outcome Measures
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 ]

Eligibility Criteria
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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
Contacts and Locations

Locations
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France
PFRS
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Layout table for investigator information
Study Chair: Antoine Gauthier UMR 1075 COMETE
Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date July 20, 2020
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • driving performances [ Time Frame: baseline ]
    number of lateral deviations of the vehicule
  • sleepiness (vigilance) [ Time Frame: baseline ]
    Psychomotor vigilance test (PVT)
  • fatigue (vigilance) [ Time Frame: baseline ]
    Karolinska Sleepiness Scale (KSS),
  • motor coordination (vigilance) [ Time Frame: baseline ]
    the angle of the steering wheel
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • sleep [ Time Frame: baseline ]
    (EEG : Fz, Cz, F4-M1, C4-M1, O2-M1, F3-M2 et O1-M2),
  • temperature [ Time Frame: baseline ]
    measured each minute with e-tact medical device
  • heart rate [ Time Frame: baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vigilance and Simulated Driving After a Nap
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Behavioral: Nap
Each participant is compared to himself in 4 conditions,
Study Arms  ICMJE
  • Experimental: nap in a bed
    the participants take a nap of 30 min in a bed in a bedroom
    Intervention: Behavioral: Nap
  • Experimental: nap in an armchair
    the participants take a nap of 30 min in a car sit in a bedroom
    Intervention: Behavioral: Nap
  • Experimental: nap in teh Sombox
    the participants take a nap of 30 min in the micro-hotel Sombox
    Intervention: Behavioral: Nap
  • Sham Comparator: no nap in a bed
    the participant stay awaked for 30 min in a bed in a bedroom
    Intervention: Behavioral: Nap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978026
Other Study ID Numbers  ICMJE ID RCB 2018-A02253-52
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Antoine Gauthier UMR 1075 COMETE
PRS Account University Hospital, Caen
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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