Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-02 @ 9:48 PM
Study NCT ID:
NCT03198156
Status:
TERMINATED
Last Update Posted:
2021-10-25
First Post:
2017-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ulysses.Magalang@osumc.edu', 'phone': '614-292- 4307', 'title': 'Dr. Ulysses Magalang', 'organization': 'The Ohio State University Wexner Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'No data was analyzed. Study was terminated due to the funding was stopped.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed through study completion (5 weeks for each participant).', 'description': 'No adverse events were observed or reported during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psychomotor Vigilance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'timeFrame': '10 minutes', 'description': 'Objective measure of sleepiness.', 'reportingStatus': 'POSTED', 'populationDescription': 'Sleepiness measure data based on Psychomotor Vigilance Test results could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.'}, {'type': 'PRIMARY', 'title': 'Epworth Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'timeFrame': '5 minutes', 'description': 'Subjective measure of sleepiness', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjective Sleepiness data based on patient report on the Epwoth Sleepiness Scale questionnaire could not be analyzed and reported in data table as were unable to be collect data from enrolled patients. This study terminated early.'}, {'type': 'SECONDARY', 'title': 'Stanford Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'timeFrame': '5 minutes', 'description': 'Subjective measure of sleepiness', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjective Sleepiness data based on Stanford Sleepiness Scale instrument could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients. This study was early terminated.'}, {'type': 'SECONDARY', 'title': 'Functional Outcomes of Sleep Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'timeFrame': '5 minutes', 'description': 'Measure of the impact of sleepiness on daytime function', 'reportingStatus': 'POSTED', 'populationDescription': 'Impact of sleepiness on daytime function based on functional outcomes of sleep questionnaire could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'timeFrame': '5 minutes', 'description': 'Subjective Measure of Sleepiness', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjective Sleepiness data based on Visual Analogue Scale (VAS) could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients.'}, {'type': 'SECONDARY', 'title': 'CES-D Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'timeFrame': '5 minutes', 'description': 'Center for Epidemiologic Studies Depression (CES-D) Scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from Center for Epidemiologic Studies Depression (CES-D) Scale could not be analyzed and reported in the table data as we were unable to collect data from enrolled patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'FG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 39 enrolled subjects, 38 met inclusion criteria and were randomized to treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions\n\nTranscranial Direct Current Stimulation: tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.'}, {'id': 'BG001', 'title': 'Sham Stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.\n\nSham stimulation: Sham stimulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.63', 'spread': '11.34', 'groupId': 'BG000'}, {'value': '38.84', 'spread': '14.27', 'groupId': 'BG001'}, {'value': '38.73', 'spread': '25.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A total of 38 subjects age data were analyzed'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.70', 'spread': '5.02', 'groupId': 'BG000'}, {'value': '29.84', 'spread': '6.67', 'groupId': 'BG001'}, {'value': '29.77', 'spread': '5.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A total of 38 subjects BMI were analyzed'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-29', 'size': 441057, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-20T14:16', 'hasProtocol': True}, {'date': '2020-01-17', 'size': 305025, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-20T14:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a 5 week randomized, sham-controlled, parallel group study involving subjects with any of the following diagnoses: Idiopathic Hypersomnia, Narcolepsy without Cataplexy, Hypersomnia in OSA patients adequately treated with PAP therapy or dental device, Posttraumatic hypersomnia, Hypersomnia, unspecified. Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of \\>8 minutes will undergo actigraphy and those with an average sleep time of \\>10 hours per day will continue with the study while those with \\<10 hours sleep time will be excluded. OSA subjects with complaints of hypersomnia with an ESS score \\<10 will be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed.\n\nSubjects will receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Funding Stopped', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2017-06-21', 'resultsFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-22', 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychomotor Vigilance Test', 'timeFrame': '10 minutes', 'description': 'Objective measure of sleepiness.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '5 minutes', 'description': 'Subjective measure of sleepiness'}], 'secondaryOutcomes': [{'measure': 'Stanford Sleepiness Scale', 'timeFrame': '5 minutes', 'description': 'Subjective measure of sleepiness'}, {'measure': 'Functional Outcomes of Sleep Questionnaire', 'timeFrame': '5 minutes', 'description': 'Measure of the impact of sleepiness on daytime function'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '5 minutes', 'description': 'Subjective Measure of Sleepiness'}, {'measure': 'CES-D Scale', 'timeFrame': '5 minutes', 'description': 'Center for Epidemiologic Studies Depression (CES-D) Scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Direct Current Stimulation', 'Without Cataplexy'], 'conditions': ['Hypersomnia']}, 'descriptionModule': {'briefSummary': '1. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in subjects with central hypersomnia without cataplexy.\n2. To determine the effects of tDCS on subjective measures of sleepiness and alertness in subjects with central hypersomnia without cataplexy.', 'detailedDescription': 'This is a randomized, sham-controlled, parallel group study. The study will last up to 5 weeks. After informed consent, subjects with idiopathic hypersomnia with an MSLT mean sleep latency of \\>8 minutes will undergo actigraphy and those with an average sleep time of \\>10 hours per day will continue with the study while those with \\<10 hours sleep time will be excluded. In addition, OSA subjects with complaints of hypersomnia with an ESS score \\<10 will also be excluded. Female subjects of child bearing age and not menopausal will have a pregnancy test performed as pregnancy is an exclusionary criteria.\n\nSubjects will be randomized to receive either active tDCS or sham stimulation for 30 minutes daily for 4 sessions. The randomization will be generated by means of a computer-generated random-number table. An unrestricted randomization scheme will be followed. Subjects will be blinded as to whether they are receiving sham or active tDCS treatments. The investigator who will conduct the analysis of all outcomes will be blinded as to subject treatment assignment.\n\nAll stimulation visits will be completed within a five-consecutive day period; that is one stimulation visit may be missed provided a total of four stimulation visits are completed within a five-day period. Outcome measures will include: psychomotor vigilance test (PVT), subjective measures of sleepiness, and the Center for Epidemiologic Studies Depression (CES-D) scale. PVT will be performed pre- and post- stimulation during the first and last stimulation sessions. Subjective measures of sleepiness include the following: Epworth Sleepiness Scale (ESS), Stanford Sleepiness Scale (SSS), Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), and Visual Analogue Scale (VAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 70 years\n* Epworth Sleepiness scale score \\>10\n* Stable medication dosage over previous 4 weeks\n* Able to understand English and read and write at the 8th grade level and give a written informed consent document.\n* Stable sleep/wake schedule (that is, no rotating shift work)\n* Clinical diagnosis of any of the following:\n\n 1. Idiopathic Hypersomnia\n 2. Narcolepsy without Cataplexy\n 3. Hypersomnia in OSA patients adequately treated with PAP therapy or dental device\n 4. Posttraumatic hypersomnia\n 5. Hypersomnia, unspecified\n* Multiple sleep latency test (MSLT) shows fewer than two sleep onset REM periods and a mean sleep latency of ≤ 8 minutes. An MSLT is not required for inclusion of OSA patients provided their Epworth Sleepiness Scale (ESS) score is \\>10. Adequately treated OSA patients will be defined as: i) an average PAP usage of \\> 4 hours per night and a residual apnea-hypopnea index (AHI) of \\<10/hour based on PAP machine download during at least a 30-day period, or ii) regular use of dental device during sleep based on self-report and a prior sleep study showing an AHI \\<10/hour while using the dental device.\n* Subjects with idiopathic hypersomnia with an MSLT mean sleep latency of \\> 8 minutes will be included provided they have hypersomnia symptoms and habitually long sleep times (average of \\>10 hours per day) documented by actigraphy for at least 7 days.18\n\nExclusion Criteria:\n\n* Self-reported habitual sleep period of \\< 7 hours/night\n* History of automobile accident due to falling asleep while driving\n* Currently taking stimulant medications such as Modafinil, Armodafinil, Methylphenidate, or Dextroamphetamnie.\n* Inability to understand or read English\n* Clear history of cataplexy\n* Moderate or severe sleep apnea defined as an apnea-hypopnea index (AHI) of \\> 15/hour based on a previous sleep study and non-compliant with treatment.\n* Self-reported Substance abuse (current)\n* Excessive alcohol consumption defined as:\n* More than 3 glasses of wine a day\n* More than 3 beers a day\n* More than 60 mL of hard liquor a day\n* Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).\n* Pregnancy, lactation\n* Recent hospitalization for major surgery/major illness (within past 1 month)\n* Non-removable metal or tattoos around head\n* Use of implantable birth control device such as Implanon\n* History of severe and frequent headaches\n* Known coronary artery disease\n* Seizure disorder\n* Uncontrolled hypertension\n* Congestive heart failure'}, 'identificationModule': {'nctId': 'NCT03198156', 'acronym': 'tDCS', 'briefTitle': 'Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy', 'orgStudyIdInfo': {'id': '2016H0434'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Direct Current Stimulation', 'description': 'Active tDCS for 30 minutes daily for 4 sessions', 'interventionNames': ['Device: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'Sham stimulation sessions will be for 30 minutes daily for each of the 4 sessions; however, active stimulation for this arm of the study is only for 30 seconds; yet, will be applied at the same intensity as the Active arm of the study, albeit for only 30 seconds.', 'interventionNames': ['Device: Sham stimulation']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'tDCS is a form of noninvasive, painless, brain stimulation that uses a mild direct electrical current passed between electrodes on the scalp to modify neuronal membrane resting potential in a polarity dependent manner, elevating or lowering neuron excitability in a region.', 'armGroupLabels': ['Transcranial Direct Current Stimulation']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': 'Sham stimulation', 'armGroupLabels': ['Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Ulysses Magalang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Air Force', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Neuroscience; Director, Sleep Medicine Program', 'investigatorFullName': 'Ulysses Magalang MD', 'investigatorAffiliation': 'Ohio State University'}}}}