Naps and Pulses of Bright Light in Shift Workers

NCT ID: NCT00487292

Last Updated: 2007-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-06-30

Brief Summary

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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

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Results are submitted to publication

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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naps and pulses of bright light

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Paris 5 - Rene Descartes

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

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damien leger, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Centre du Sommeil Hotel Dieu

pierre philip, M.D, Ph.D

Role: STUDY_DIRECTOR

Hopital Pellegrin Bordeaux

Locations

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

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 16983053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16754920 (View on PubMed)

Other Identifiers

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HDCSRE-003

Identifier Type: -

Identifier Source: org_study_id