Naps and Pulses of Bright Light in Shift Workers

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487292
• Other study ID #: HDCSRE-003
• Status: Completed
• Phase: N/A
• First received: June 15, 2007
• Last updated: June 18, 2007
• Start date: April 2003
• Est. completion date: June 2006

Study information

• Verified date: June 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Description:

Results are submitted to publication

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• naps and pulses of bright light

Locations

Country	Name	City	State
France	Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

References & Publications (2)

Léger 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG sleepiness at the wheel		two periods of 8 hours driving
Secondary	subjective sleepiness at the stanford sleepinesss scale		two periods of 8 hours driving