Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT02956161
Status:
COMPLETED
Last Update Posted:
2016-11-07
First Post:
2016-10-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of the amplitude of sleep slow oscillations', 'timeFrame': '3 days', 'description': 'Amplitude of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal.'}], 'secondaryOutcomes': [{'measure': 'Variation of the number of sleep slow oscillations', 'timeFrame': '3 days', 'description': 'Number of sleep slow oscillation assessed during N3 sleep stages throughout 3 separate nights. The analysis is based on electroencephalography signal.'}, {'measure': 'Variation of N3 sleep stage duration', 'timeFrame': '3 days', 'description': 'N3 sleep duration assessed throughout 3 separate nights. The analysis is based on double scoring of polysomnography signal.'}, {'measure': 'Variation of the number of remembered words in declarative memory tasks (word pair task)', 'timeFrame': '3 days', 'description': 'Number of remembered words assessed 3 separate days (30 min after awakening).'}, {'measure': 'Variation of mood assessment measured with the profile of mood scale (POMS)', 'timeFrame': '3 days', 'description': 'Mood assessed 3 separate days (30 min after awakening).'}, {'measure': 'Variation of subjective sleepiness measured with the Karolinska sleepiness scale (KSS)', 'timeFrame': '3 days', 'description': 'Subjective sleepiness assessed 3 separate days (30 min after awakening).'}, {'measure': 'Variation of average response time variation and omissions in the Psychomotor vigilance task (PVT)', 'timeFrame': '3 days', 'description': 'Psychomotor vigilance assessed 3 separate days (30 min after awakening).'}, {'measure': 'Variation of salivary cortisol concentration', 'timeFrame': '3 days', 'description': 'Salivary cortisol concentration assessed 3 separate days (5 min after awakening).'}, {'measure': 'Variation of salivary testosterone concentration', 'timeFrame': '3 days', 'description': 'Salivary testosterone concentration assessed 3 separate days (5 min after awakening).'}, {'measure': 'Variation of mental rotation capacity (mental rotatory task)', 'timeFrame': '3 days', 'description': 'Mental rotation capacity assessed 3 separate days (30 min after awakening).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep', 'Auditory stimulations', 'Slow oscillations'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.', 'detailedDescription': 'Sleep quality impairment has long been identified as a risk factor to develop cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep, characterized by slow oscillations, has a major role on memory and hormones releasing. Here, we aim to assess a miniaturized sleep device that would automatically detect and stimulate sleep slow oscillations with sounds to enhance deep sleep quality.\n\nThe subjects realize 3 conditions :\n\n* Up condition : Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.\n* Random condition : Auditory stimulations are randomly delivered during N3 sleep stage.\n* Placebo condition: The device is worn without any auditory stimulations delivered.\n\nThe subjects are equipped with a reference polysomnography and the auditory stimulation device during 3 nights and one habituation night prior to them. A wash out period of 6 days between each night will be respected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subject\n* moderate morningness, intermediate or moderate eveningness chronotype (Horne \\& Östberg questionnaire)\n\nExclusion Criteria:\n\n* sleep disorder according to the ICSD-3 or DSM-5\n* travelling away from more than a time zone in the previous month\n* acute or chronic disorders (cardio-vascular, respiratory, neurologic, psychiatric)\n* night shifts work\n* smoking more than 5 cigarettes per day\n* drinking more than 5 glass of alcohol per week\n* consuming excessive drinks with xanthics (coffee, tea, coke more than 6 cups per day).\n* having a body mass index \\>30kg.m -2\n* being pregnant'}, 'identificationModule': {'nctId': 'NCT02956161', 'acronym': 'STIMENPHASE', 'briefTitle': 'Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dreem'}, 'officialTitle': 'Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep', 'orgStudyIdInfo': {'id': 'STIMENPHASE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Up phase stimulation', 'description': 'Auditory stimulations are delivered in synchrony with the up phase of slow oscillations during N3 sleep stage.', 'interventionNames': ['Device: Stimulation of up-phase of sleep slow oscillation']}, {'type': 'EXPERIMENTAL', 'label': 'Random phase stimulation', 'description': 'Auditory stimulations are randomly delivered during N3 sleep stage.', 'interventionNames': ['Device: Random stimulation of up phase of sleep slow oscillation']}, {'type': 'SHAM_COMPARATOR', 'label': 'No stimulation', 'description': 'The device is worn without any auditory stimulations delivered.', 'interventionNames': ['Device: No stimulation']}], 'interventions': [{'name': 'Stimulation of up-phase of sleep slow oscillation', 'type': 'DEVICE', 'armGroupLabels': ['Up phase stimulation']}, {'name': 'Random stimulation of up phase of sleep slow oscillation', 'type': 'DEVICE', 'armGroupLabels': ['Random phase stimulation']}, {'name': 'No stimulation', 'type': 'DEVICE', 'armGroupLabels': ['No stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Damien Léger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris'}, {'name': 'Mounir Chennaoui, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EA 7330 VIFASOM, University of Paris Descartes, Sorbonne Cité, Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dreem', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Paris 5 - Rene Descartes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}