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Naps and Pulses of Bright Light in Shift Workers

Primary Purpose

Sleep

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

naps and pulses of bright light

About this trial

This is an interventional prevention trial for Sleep focused on measuring accidents, shift work, sleepiness, naps, bright light pulses, sleep

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame

Outcomes

Primary Outcome Measures

EEG sleepiness at the wheel

Secondary Outcome Measures

subjective sleepiness at the stanford sleepinesss scale

Full Information

NCT ID

NCT00487292

First Posted

June 15, 2007

Last Updated

June 18, 2007

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University of Paris 5 - Rene Descartes

1. Study Identification

Unique Protocol Identification Number

NCT00487292

Brief Title

Naps and Pulses of Bright Light in Shift Workers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University of Paris 5 - Rene Descartes

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

Results are submitted to publication

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep

Keywords

accidents, shift work, sleepiness, naps, bright light pulses, sleep

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

naps and pulses of bright light

Primary Outcome Measure Information:

Title

EEG sleepiness at the wheel

Time Frame

two periods of 8 hours driving

Secondary Outcome Measure Information:

Title

subjective sleepiness at the stanford sleepinesss scale

Time Frame

two periods of 8 hours driving

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

damien leger, M.D, Ph.D

Organizational Affiliation

Centre du Sommeil Hotel Dieu

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

pierre philip, M.D, Ph.D

Organizational Affiliation

Hopital Pellegrin Bordeaux

Official's Role

Study Director

Facility Information:

Facility Name

Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame

City

Paris

ZIP/Postal Code

75181 Paris CEDEx 04

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

16983053

Citation

Leger D, Annesi-Maesano I, Carat F, Rugina M, Chanal I, Pribil C, El Hasnaoui A, Bousquet J. Allergic rhinitis and its consequences on quality of sleep: An unexplored area. Arch Intern Med. 2006 Sep 18;166(16):1744-8. doi: 10.1001/archinte.166.16.1744.

Results Reference

background

PubMed Identifier

16754920

Citation

Philip P, Taillard J, Moore N, Delord S, Valtat C, Sagaspe P, Bioulac B. The effects of coffee and napping on nighttime highway driving: a randomized trial. Ann Intern Med. 2006 Jun 6;144(11):785-91. doi: 10.7326/0003-4819-144-11-200606060-00004.

Results Reference

background

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Naps and Pulses of Bright Light in Shift Workers

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