Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04461769
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070263', 'term': 'Sleep Hygiene'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants were blind to which night was stimulation. Experimenters were blinded until the participant was asleep, when they opened an email that specified delivery of stimulation or sham.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'N3 Duration', 'timeFrame': 'Measured during the night of sleep (typically 8 hours)', 'description': 'Duration in minutes of N3 sleep'}], 'secondaryOutcomes': [{'measure': 'N3 Percentage', 'timeFrame': 'Measured during the night of sleep (typically 8 hours)', 'description': "Percentage of the night's sleep spent in N3"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Sleep Hygiene']}, 'descriptionModule': {'briefSummary': 'This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.', 'detailedDescription': 'Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* history of seizures\n* epilepsy\n* brain trauma or injury\n* insomnia\n* sleep apnea\n* medications that may affect the EEG.'}, 'identificationModule': {'nctId': 'NCT04461769', 'acronym': 'ESSOTEDS', 'briefTitle': 'Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brain Electrophysiology Laboratory Company'}, 'officialTitle': 'Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep', 'orgStudyIdInfo': {'id': 'R44MH115955', 'link': 'https://reporter.nih.gov/quickSearch/R44MH115955', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow Oscillation Synchronization with TES', 'description': 'Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.', 'interventionNames': ['Device: Transcranial Electrical Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Control', 'description': 'No current delivered.', 'interventionNames': ['Device: Transcranial Electrical Stimulation']}], 'interventions': [{'name': 'Transcranial Electrical Stimulation', 'type': 'DEVICE', 'otherNames': ['Sleep WISP (Wireless Interface Sensor Pod)'], 'description': 'Oscillating electrical current', 'armGroupLabels': ['Sham Control', 'Slow Oscillation Synchronization with TES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97405', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Brain Electrophysiology Laboratory Company', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brain Electrophysiology Laboratory Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}