Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487292
Status:
COMPLETED
Last Update Posted:
2007-06-19
First Post:
2007-06-15
Brief Title:
Naps and Pulses of Bright Light in Shift Workers
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None