Naps and Pulses of Bright Light in Shift Workers

NCT00487292 | Completed DMC

• 1 other identifier: HDCSRE-003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

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

Outcome Measures

Primary Outcomes (1)

• EEG sleepiness at the wheel

  two periods of 8 hours driving

Secondary Outcomes (1)

• subjective sleepiness at the stanford sleepinesss scale

  two periods of 8 hours driving

Interventions

naps and pulses of bright light BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A professional experience of at least one year

You may not qualify if:

• With an history of chronic disease,treatments (or toxic)
• Subjects with a suspicion of sleep disorders
• Snorers

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University of Paris 5 - Rene Descartes: collaborator

Study Sites (1)

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

Paris, 75181 Paris CEDEx 04, France

Location

Related Publications (2)

• 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.

  PMID: 16983053 BACKGROUND

• 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.

  PMID: 16754920 BACKGROUND

MeSH Terms

Conditions

Sleepiness

Interventions

N-(4-aminophenethyl)spiroperidol

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• damien leger, M.D, Ph.D

  Centre du Sommeil Hotel Dieu

  PRINCIPAL INVESTIGATOR

• pierre philip, M.D, Ph.D

  Hopital Pellegrin Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: April 1, 2003
• Study Completion: June 1, 2006
• Last Updated: June 19, 2007

Record last verified: 2007-06

Locations

FR (1)