Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-04 @ 2:01 PM
Study NCT ID:
NCT04570761
Status:
UNKNOWN
Last Update Posted:
2023-10-06
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.', 'timeFrame': 'Day 7', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.'}, {'measure': 'difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.', 'timeFrame': 'Day 8', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.'}, {'measure': 'difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.', 'timeFrame': 'Day 14', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.'}, {'measure': 'difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.', 'timeFrame': 'Day 15', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.'}], 'secondaryOutcomes': [{'measure': 'Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.', 'timeFrame': 'Day 7', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.'}, {'measure': 'Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.', 'timeFrame': 'Day 8', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.'}, {'measure': 'Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.', 'timeFrame': 'Day 14', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.'}, {'measure': 'Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.', 'timeFrame': 'Day 15', 'description': 'gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.'}, {'measure': "The memory complaint for Mc Nair's Questionnaire", 'timeFrame': 'Baseline', 'description': 'score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.'}, {'measure': 'Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)', 'timeFrame': 'Baseline', 'description': 'score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.'}, {'measure': 'Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)', 'timeFrame': 'Baseline', 'description': 'score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.'}, {'measure': 'Quality of sleep for Pittsburgh Index (PSQI)', 'timeFrame': 'Baseline', 'description': 'It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.'}, {'measure': "The memory complaint for Mc Nair's Questionnaire", 'timeFrame': 'Day 15', 'description': 'score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.'}, {'measure': 'Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)', 'timeFrame': 'Day 15', 'description': 'score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.'}, {'measure': 'Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)', 'timeFrame': 'Day 15', 'description': 'score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.'}, {'measure': 'Quality of sleep for Pittsburgh Index (PSQI)', 'timeFrame': 'Day 15', 'description': 'It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.'}, {'measure': 'amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition', 'timeFrame': 'Day 7', 'description': 'gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device'}, {'measure': 'amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition', 'timeFrame': 'Day 8', 'description': 'gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device'}, {'measure': 'amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition', 'timeFrame': 'Day 14', 'description': 'gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device'}, {'measure': 'amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition', 'timeFrame': 'Day 15', 'description': 'gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease (AD)"]}, 'descriptionModule': {'briefSummary': "Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.\n\nA method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.\n\nThe hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.", 'detailedDescription': "Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.\n\nA method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.\n\nThe hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria common to all participants:\n\n* Age\\> 50 years at the inclusion\n* Patient with regular sleep patterns\n* Patient having given written consent\n* Patient affiliated to a social security regimen\n\nInclusion criteria for subjects with Alzheimer's disease:\n\n* Patient with a beginning Alzheimer's disease defined according to the criteria of the National Institute on Aging-Alzheimer's Association or carriers of a prodromal Alzheimer's disease defined according to the criteria of the International Working Group IWG-2; the diagnosis must be supported by brain imaging and a blood test carried out in routine care\n* MMSE score ≥ 24\n\nInclusion criteria for healthy volunteers:\n\n* Absence of neurodegenerative pathologies\n* Matched in age (+/- 5 years) and in sex with a patient\n\nNon-inclusion criteria common to all participants:\n\n* Psychiatric pathologies (except depression or anxiety disorders stabilized for more than 3 months)\n* History of pathology which may have consequences on cognitive functioning and / or sleep: brain tumor, constituted stroke, epilepsy, head trauma (with clinical or parenchymal sequelae objectified on brain imagery), brain surgery\n* Any significant comorbidity likely to constitute a confounding factor according to the clinician\n* Psychotropic treatments introduced or modified \\<3 months before inclusion\n* Hypnotic and / or sedative treatments\n* Chronic consumption of alcohol or drugs\n* Legal incapacity and / or other circumstance rendering the patient unable to understand the nature, objective or consequences of the study\n* Major under guardianship or curatorship\n* Patient not French-speaking by birth or illiterate\n\nExclusion Criteria common to all participants:\n\n* Sleep disorders defined by a score\\> 5 on the Pittsburg sleep quality index (PSQI)\n* A score\\> 10 on the Epworth sleepiness index"}, 'identificationModule': {'nctId': 'NCT04570761', 'acronym': 'PINK-AD', 'briefTitle': 'Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer\'s Disease: Proof of Concept Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer\'s Disease: Proof of Concept Study', 'orgStudyIdInfo': {'id': 'DR200077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ON-Stim', 'description': 'acoustic stimulation', 'interventionNames': ['Device: Dreem headband']}, {'type': 'SHAM_COMPARATOR', 'label': 'OFF-Stim', 'description': 'no acoustic stimulation', 'interventionNames': ['Device: Dreem headband']}], 'interventions': [{'name': 'Dreem headband', 'type': 'DEVICE', 'description': 'acoustic stimulation', 'armGroupLabels': ['ON-Stim']}, {'name': 'Dreem headband', 'type': 'DEVICE', 'description': 'acoustic stimulation', 'armGroupLabels': ['OFF-Stim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anna-Chloé BALAGEAS, PhD', 'role': 'CONTACT', 'email': 'a.balageas@chu-tours.fr', 'phone': '0234378952'}, {'name': 'Anna-Chloé BALAGEAS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Valerie GISSOT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Anna-Chloé BALAGEAS, PhD', 'role': 'CONTACT', 'email': 'a.balageas@chu-tours.fr', 'phone': '0234378952', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}