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Naps and Pulses of Bright Light in Shift Workers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487292
First Posted: June 18, 2007
Last Update Posted: June 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose

Design: paired trials without and with naps and bright light. Setting: Real driving on a private road circuit. Environmental controlled car. Participants: 9 shift workers on tree shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by ambulatory polysomnography and assessed using 30 seconds segments of recordings when the percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).

Intervention: Participants drove the same car on two similar 24 hours periods of work, with three pilots in each shift (morning, afternoon, night), separated by three weeks. During the baseline period, the subjects were told to manage their rest as they usually do in the real life. During the second experimental period, they had to rest lied in a dark room during two naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.


Condition Intervention
Sleep Behavioral: naps and pulses of bright light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • EEG sleepiness at the wheel [ Time Frame: two periods of 8 hours driving ]

Secondary Outcome Measures:
  • subjective sleepiness at the stanford sleepinesss scale [ Time Frame: two periods of 8 hours driving ]

Enrollment: 9
Study Start Date: April 2003
Study Completion Date: June 2006
Detailed Description:
Results are submitted to publication
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A professional experience of at least one year

Exclusion Criteria:

  • With an history of chronic disease,treatments (or toxic)
  • Subjects with a suspicion of sleep disorders
  • Snorers
  Contacts and Locations
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): NCT00487292


Locations
France
Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame
Paris, France, 75181 Paris CEDEx 04
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
University of Paris 5 - Rene Descartes
Investigators
Principal Investigator: damien leger, M.D, Ph.D Centre du Sommeil Hotel Dieu
Study Director: pierre philip, M.D, Ph.D Hopital Pellegrin Bordeaux
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00487292     History of Changes
Other Study ID Numbers: HDCSRE-003
First Submitted: June 15, 2007
First Posted: June 18, 2007
Last Update Posted: June 19, 2007
Last Verified: June 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
accidents
shift work
sleepiness
naps
bright light pulses
sleep