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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris University of Paris 5 - Rene Descartes |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00487292 |
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 |
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Sleep |
Behavioral: naps and pulses of bright light |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study |
Enrollment: | 9 |
Study Start Date: | April 2003 |
Study Completion Date: | June 2006 |
Results are submitted to publication
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame | |
paris, France, 75181 Paris CEDEx 04 |
Principal Investigator: | damien leger, M.D, Ph.D | Centre du Sommeil Hotel Dieu |
Study Director: | pierre philip, M.D, Ph.D | Hopital Pellegrin Bordeaux |
Study ID Numbers: | HDCSRE-003 |
Study First Received: | June 15, 2007 |
Last Updated: | June 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00487292 |
Health Authority: | France: French Data Protection Authority |
accidents shift work sleepiness |
naps bright light pulses sleep |