Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-03-07 @ 10:44 PM
Study NCT ID:
NCT02778659
Status:
COMPLETED
Last Update Posted:
2018-01-05
First Post:
2016-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnotic Intake and Motor and Cognitive Performances at High Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-04', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive performance assessed using Simon cognitive test', 'timeFrame': '4 hours after drug/placebo intake', 'description': 'Simon cognitive test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physiology']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No sojourn above 2500 m during the past 2 months\n* Coffee intake \\< 3 cups per day\n* Non-smoker\n\nExclusion Criteria:\n\n* Respiratory, cardiovascular, metabolic or neuromuscular diseases\n* Psychiatric disorders\n* Use of hypnotics within the past year\n* Dependence syndrome (alcool, drugs, etc)\n* Severe insomnia or somnolence'}, 'identificationModule': {'nctId': 'NCT02778659', 'acronym': 'CHAM', 'briefTitle': 'Hypnotic Intake and Motor and Cognitive Performances at High Altitude', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Expertise sur l'Altitude EXALT"}, 'officialTitle': 'The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances', 'orgStudyIdInfo': {'id': 'CHAM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zolpidem Normoxia', 'description': 'Acute zolpidem intake at sea level', 'interventionNames': ['Drug: Zolpidem']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Normoxia', 'description': 'Acute placebo intake at sea level', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Zolpidem Hypoxia', 'description': 'Acute zolpidem intake at high altitude', 'interventionNames': ['Drug: Zolpidem']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Hypoxia', 'description': 'Acute placebo intake at high altitude', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zolpidem', 'type': 'DRUG', 'description': 'The hypnotic will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.', 'armGroupLabels': ['Zolpidem Hypoxia', 'Zolpidem Normoxia']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.', 'armGroupLabels': ['Placebo Hypoxia', 'Placebo Normoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Pierre Bouzat, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Expertise sur l'Altitude EXALT", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}