Naps and Pulses of Bright Light in Shift Workers

June 18, 2007 updated by: Assistance Publique - Hôpitaux de Paris

The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Sleep

Intervention / Treatment

Behavioral: naps and pulses of bright light

Detailed Description

Results are submitted to publication

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 75181 Paris CEDEx 04
    - Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
EEG sleepiness at the wheel Time Frame: two periods of 8 hours driving	two periods of 8 hours driving

Secondary Outcome Measures

Outcome Measure	Time Frame
subjective sleepiness at the stanford sleepinesss scale Time Frame: two periods of 8 hours driving	two periods of 8 hours driving

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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, Hôpital Pellegrin Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria