Naps and Pulses of Bright Light in Shift Workers | NCT00487292

Studies
Naps and Pulses of Bright Light in Shift Workers

NCT00487292

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jun 19, 2007Estimated

Enrollment

9Actual

Phase

Not Applicable

Conditions

Sleep

Interventions

naps and pulses of bright light

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Jun 15, 2007

First Submission Date that Met QC Criteria

Jun 15, 2007

First Posted Date

Jun 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2007

Last Update Posted Date

Jun 19, 2007Estimated

Name	Class
University of Paris 5 - Rene Descartes	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Name	Type	Description	Arm Group Labels	Other Names
naps and pulses of bright light	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EEG sleepiness at the wheel		two periods of 8 hours driving

Secondary Outcomes

Measure	Description	Time Frame
subjective sleepiness at the stanford sleepinesss scale		two periods of 8 hours driving

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
damien leger, M.D, Ph.D	Centre du Sommeil Hotel Dieu	Principal Investigator
pierre philip, M.D, Ph.D	Hopital Pellegrin Bordeaux	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame		Paris		75181 Paris CEDEx 04	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16983053	Background	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.
16754920	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.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms