Naps and Pulses of Bright Light in Shift Workers

This study has been completed.
Sponsor:
Collaborator:
University of Paris 5 - Rene Descartes
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00487292
First received: June 15, 2007
Last updated: June 18, 2007
Last verified: June 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 15, 2007
Last Updated: June 18, 2007
Health Authority: France: French Data Protection Authority

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

ClinicalTrials.gov processed this record on July 20, 2014