Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-05 @ 5:05 PM
Study NCT ID:
NCT03112902
Status:
TERMINATED
Last Update Posted:
2021-12-17
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brice.mcconnell@cuanschutz.edu', 'phone': '303-724-3897', 'title': 'Brice McConnell', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "During this trial we made compelling discoveries into the nature of slow wave sleep that undermined the rationale and data analysis plan for this trial. Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed."}}, 'adverseEventsModule': {'timeFrame': '30 months (approx)', 'description': 'Adverse events were monitored after every period of participant data collection/study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Effects of tACS During SWS- Standard/Nested 1', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis is a triple crossover: standard tACS, then nested, then sham', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Effects of tACS During SWS- Standard/Nested 2', 'description': 'This is a triple crossover: standard tACS, then sham, then nested tACS', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Effects of tACS During SWS- Standard/Nested 3', 'description': 'This is a triple crossover: sham, then nested tACS, then standard tACS,', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Effects of tACS During SWS- Standard/Nested 4', 'description': 'This is a triple crossover: sham, then standard tACS, then nested tACS,', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Effects of tACS During SWS- Standard/Nested 5', 'description': 'This is a triple crossover: nested tACS, then sham, then standard tACS,', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Effects of tACS During SWS- Standard/Nested 6', 'description': 'This is a triple crossover: nested tACS, then standard tACS then sham.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Effects of tACS During SWS- Older Adults Active 1', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis is a crossover: standard tACS, then sham', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Effects of tACS During SWS- Older Adults Active 2', 'description': 'This is a crossover: sham and then standard tACS', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Effects of tACS During SWS- MCI Active 1', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis is a crossover: standard tACS, then sham', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Effects of tACS During SWS- MCI Active 2', 'description': 'This is a crossover: sham and then standard tACS', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': 'Power of EEG data in microvolts within slow wave frequency range.', 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'type': 'SECONDARY', 'title': 'Change in Declarative Memory Encoding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject.', 'description': 'Word-paired associations', 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Finger tapping task \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Sleep Architecture as Measured by Minutes in Each Stage of Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': 'EEG data \\*No processing of data occurred to provide information about this outcome measure.', 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "EEG data \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "EEG data \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "EEG data \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Sleep diary for subjective experience \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Mood outcome \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Global assessment \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Assessment of working memory \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for the study outcome measures."}, {'type': 'SECONDARY', 'title': 'Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Effects of tACS During SWS- Standard', 'description': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.\n\nThis was part of a triple crossover'}, {'id': 'OG001', 'title': 'Effects of tACS During SWS- Nested', 'description': 'This was part of a triple crossover'}, {'id': 'OG002', 'title': 'Effects of tACS During SWS- Older Adults Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}, {'id': 'OG003', 'title': 'Effects of tACS During SWS- MCI Active', 'description': 'This is a cross-over with a sham control condition\n\nApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.'}], 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Assessment of attention \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure", 'reportingStatus': 'POSTED', 'populationDescription': "Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. 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'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 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{'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Study terminated prior to completion enrollment, and prior to any enrollment of MCI arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-04', 'size': 479684, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-22T16:11', 'hasProtocol': True}, {'date': '2021-06-06', 'size': 130692, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-22T16:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Compelling insights impacting the scientific rationale', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2017-03-24', 'resultsFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-29', 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': 'Power of EEG data in microvolts within slow wave frequency range.'}], 'secondaryOutcomes': [{'measure': 'Change in Declarative Memory Encoding', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject.', 'description': 'Word-paired associations'}, {'measure': 'Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Finger tapping task \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Sleep Architecture as Measured by Minutes in Each Stage of Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': 'EEG data \\*No processing of data occurred to provide information about this outcome measure.'}, {'measure': 'Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "EEG data \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "EEG data \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "EEG data \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Sleep diary for subjective experience \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Mood outcome \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Global assessment \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Assessment of working memory \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Assessment of attention \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}, {'measure': 'Change in Battery of Visuospatial Processing Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.', 'timeFrame': 'Before and after each night of study session, up to 24 weeks from enrollment for each subject', 'description': "Assessment of visuospatial ability \\*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure"}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies suggest that correction of sleep deterioration may slow the progression of brain damage in mild cognitive impairment, and might be able to stop the development of Alzheimer's disease. Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small amounts of electricity through the brain, with direct effects on brain cell function. Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to improve memory when applied during sleep in healthy adults. The purpose of this research is to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among normal healthy adults, older adults, as well as individuals with MCI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-85\n* Native English speakers\n* Neurological diagnosis of amnestic mild cognitive impairment (aMCI)\n\nExclusion Criteria:\n\n* brain tumors\n* skull defects\n* epilepsy\n* metal implants/devices above the neck\n* eczema or sensitive skin\n* insomnia\n* sleep apnea that requires use of a CPAP machine\n* rapid eye movement (REM)-sleep behavior disorder\n* currently pregnant or trying to become pregnant during the study period\n* diagnosis of cognitive impairment \\*cognitive impairment required for MCI arms'}, 'identificationModule': {'nctId': 'NCT03112902', 'briefTitle': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance', 'orgStudyIdInfo': {'id': '16-1875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Standard/Nested 1', 'description': 'This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Older Adults Active 1', 'description': 'This is a double cross-over with a sham control condition; the tACS administered first, then the sham', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- MCI Active 1', 'description': 'This is a cross-over with a sham control condition; the standard tACS administered first, then sham.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Standard/Nested 2', 'description': 'This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Standard/Nested 3', 'description': 'This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Older Adults Active 2', 'description': 'This is a double cross-over with a sham control condition; the sham administered first, then the tACS.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- MCI Active 2', 'description': 'This is a cross-over with a sham control condition; the sham administered first, then standard tACS.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Standard/Nested 4', 'description': 'This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Standard/Nested 5', 'description': 'This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Effects of tACS during SWS- Standard/Nested 6', 'description': 'This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham.', 'interventionNames': ['Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance']}], 'interventions': [{'name': 'Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance', 'type': 'DEVICE', 'description': 'Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.', 'armGroupLabels': ['Effects of tACS during SWS- MCI Active 1', 'Effects of tACS during SWS- MCI Active 2', 'Effects of tACS during SWS- Older Adults Active 1', 'Effects of tACS during SWS- Older Adults Active 2', 'Effects of tACS during SWS- Standard/Nested 1', 'Effects of tACS during SWS- Standard/Nested 2', 'Effects of tACS during SWS- Standard/Nested 3', 'Effects of tACS during SWS- Standard/Nested 4', 'Effects of tACS during SWS- Standard/Nested 5', 'Effects of tACS during SWS- Standard/Nested 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado AMC', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Brice McConnell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}