Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-25 @ 7:02 AM
Study NCT ID:
NCT00487292
Status:
COMPLETED
Last Update Posted:
2007-06-19
First Post:
2007-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naps and Pulses of Bright Light in Shift Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077260', 'term': 'Sleepiness'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043186', 'term': 'N-(4-aminophenethyl)spiroperidol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-18', 'studyFirstSubmitDate': '2007-06-15', 'studyFirstSubmitQcDate': '2007-06-15', 'lastUpdatePostDateStruct': {'date': '2007-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG sleepiness at the wheel', 'timeFrame': 'two periods of 8 hours driving'}], 'secondaryOutcomes': [{'measure': 'subjective sleepiness at the stanford sleepinesss scale', 'timeFrame': 'two periods of 8 hours driving'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['accidents', 'shift work', 'sleepiness', 'naps', 'bright light pulses', 'sleep'], 'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '16983053', 'type': 'BACKGROUND', 'citation': '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': '16754920', 'type': 'BACKGROUND', '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. doi: 10.7326/0003-4819-144-11-200606060-00004.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nIntervention: 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.', 'detailedDescription': 'Results are submitted to publication'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A professional experience of at least one year\n\nExclusion Criteria:\n\n* With an history of chronic disease,treatments (or toxic)\n* Subjects with a suspicion of sleep disorders\n* Snorers'}, 'identificationModule': {'nctId': 'NCT00487292', 'briefTitle': 'Naps and Pulses of Bright Light in Shift Workers', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study', 'orgStudyIdInfo': {'id': 'HDCSRE-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'naps and pulses of bright light', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75181 Paris CEDEx 04', 'city': 'Paris', 'country': 'France', 'facility': 'Centre du Sommeil Hôtel Dieu de Paris, 1 place Parvis Notre Dame', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'damien leger, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre du Sommeil Hotel Dieu'}, {'name': 'pierre philip, M.D, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hopital Pellegrin Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Paris 5 - Rene Descartes', 'class': 'OTHER'}]}}}