Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-29 @ 7:19 AM
Study NCT ID:
NCT00520832
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2007-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2007-08-23', 'studyFirstSubmitQcDate': '2007-08-23', 'lastUpdatePostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Epworth Sleepiness Scale'}, {'measure': 'Insomnia Severity Index'}]}, 'conditionsModule': {'keywords': ['Primary Insomnia', 'Microcurrent Therapy', 'Sleep Surveys'], 'conditions': ['Primary Insomnia']}, 'descriptionModule': {'briefSummary': 'Participants identified as having primary insomnia will be randomly assigned to groups receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The microcurrent device used is FDA approved for the treatment of insomnia.\n\nThe hypothesis is that the experimental group will have significantly improved scores on three sleep surveys after treatment while the sham group will not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student, Faculty or Staff\n* Age 18 - 40\n* Symptoms of primary insomnia\n\nExclusion Criteria:\n\n* No implanted electric devices\n* No local infection, injury or malignancy\n* No history of seizure or other neurological disorders\n* No current use of prescription or other substances that could effect sleep quality or quantity\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00520832', 'briefTitle': 'A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys', 'organization': {'class': 'OTHER', 'fullName': 'Logan College of Chiropractic'}, 'officialTitle': 'A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys', 'orgStudyIdInfo': {'id': 'SR0524070091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MC-E', 'description': '20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.', 'interventionNames': ['Device: Microcurrent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MC-P', 'description': 'Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.', 'interventionNames': ['Device: Microcurrent']}], 'interventions': [{'name': 'Microcurrent', 'type': 'DEVICE', 'description': '20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.', 'armGroupLabels': ['MC-E']}, {'name': 'Microcurrent', 'type': 'DEVICE', 'description': 'Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.', 'armGroupLabels': ['MC-P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Logan College of Chiropractic', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}], 'overallOfficials': [{'name': 'Rodger Tepe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Logan College of Chiropractic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Logan College of Chiropractic', 'class': 'OTHER'}}}}