Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-01 @ 3:22 AM
Study NCT ID:
NCT00560456
Status:
COMPLETED
Last Update Posted:
2010-04-20
First Post:
2007-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Sleep Restriction and Driving
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D012913', 'term': 'Snoring'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-19', 'studyFirstSubmitDate': '2007-11-16', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard deviation from the centre of the road on driving simulator', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Number of inappropriate line crossing on driving simulator Number of lapses assessed by SRTT 10 % of slowest reaction time Mean sleep latency at 6*20-minutes multi sleep latency test. Subjective sleepiness (Karolinska and VAS) Nocturnal PSG', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness'], 'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'Young subjects and patients with nocturnal respiratory disorders are frequently involved in sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or snorers on simulated driving, objective and subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.', 'detailedDescription': "Principal objective :\n\nTo determine whether chronic sleep restriction affects more snorers driving performances than healthy subjects' driving performances.\n\nTo determine whether chronic sleep restriction affects more young people driving performances than mature subjects' driving performances.\n\nSecondary objective :\n\nTo determine whether chronic sleep restriction affects more snorers reaction time performance and sleepiness than non snorers subjects'.\n\nTo determine whether chronic sleep restriction affects more young people reaction time performance and sleepiness than mature subjects'.\n\nTo determine how age and snoring intensity affects the degradation of performance over the 5 days of sleep deprivation.\n\nTo determine age-related changes in the time course of sleepiness during 5 days of chronic sleep restriction.\n\nTo compare the impact of total sleep or chronic sleep restriction on driving performances according to the age and snoring intensity.\n\nTo determine recovery facilities to chronic sleep restriction according to the age and snoring intensity.\n\nStudy plan :\n\nG2: Group of subjects:\n\n* patients\n* controls\n\nB1: Baseline normal night:\n\nOne night of normal sleep\n\nA2: Acute sleep deprivation:\n\nNight 1: night of total sleep deprivation Night 2: night of sleep recovery\n\nC6: Chronic sleep deprivation:\n\nNight 1 to 5: nights of sleep restriction Night 6: night of sleep recovery\n\nExperimental plan : S20 \\<G2\\> \\*B1 \\* A2 \\*C6"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects inclusion criteria :\n\n* Healthy males without snoring nor subjective daytime sleepiness (Epworth \\<9)\n* Intermediate chronotype\n* Hypopnea/apnea index \\<5\n* Periodic movement index \\<5\n* Sleep efficiency \\> 85 %\n* Not taking medication modifying alertness\n* Mean driving distance per year 15000 km\n* Regular sleep-wake schedule.\n\nSnorers inclusion criteria :\n\n* Snoring males without subjective daytime sleepiness (Epworth \\<9)\n* Intermediate chronotype\n* Hypopnea/apnea index \\<5\n* Periodic movement index \\< 5\n* Sleep efficiency \\> 85 %\n* Not taking medication modifying alertness\n* Mean driving distance per year 15000 km\n* Regular sleep-wake schedule\n\nExclusion Criteria:\n\nHealthy subjects exclusion criteria :\n\n* Short or long sleeper\n* Shift- or night-worker\n* Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders\n* Alcohol\n* Consumption of illicit drugs.\n\nSnorers exclusion criteria :\n\n* Short or long sleeper\n* Shift- or night-worker\n* Mood, neurological, cardiovascular, pulmonary, endocrinological,… disorders,\n* Sleep disorder except snoring\n* Alcohol\n* Consumption of illicit drugs.'}, 'identificationModule': {'nctId': 'NCT00560456', 'acronym': 'PRIVASOM', 'briefTitle': 'Chronic Sleep Restriction and Driving', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors', 'orgStudyIdInfo': {'id': 'CHUBX 2006/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'snorers', 'interventionNames': ['Other: Chronic sleep restriction and driving simulator']}, {'type': 'OTHER', 'label': '2', 'description': 'healthy volonters (control)', 'interventionNames': ['Other: Chronic sleep restriction and driving simulator']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'young subjects', 'interventionNames': ['Other: Chronic sleep restriction and driving simulator']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'mature subjects', 'interventionNames': ['Other: Chronic sleep restriction and driving simulator']}], 'interventions': [{'name': 'Chronic sleep restriction and driving simulator', 'type': 'OTHER', 'description': '* One night of normal sleep\n* Driving simulator\n* Night 1: night of total sleep deprivation\n* Night 2: night of sleep recovery\n* Night 1 to 5: nights of sleep restriction\n* Driving simulator after night 1 to 5\n* Night 6: night of sleep recovery\n* Driving simulator', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital Bordeaux, Groupe Hospitalier Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': "Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Pierre Philip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bordeaux, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'PREDIT Go4', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Jean-Pierre LEROY / Clinical Research and Innovation Director', 'oldOrganization': 'University Hospital, Bordeaux'}}}}