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Compelling insights impacting the scientific rationale
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effects of tACS during SWS- Standard/Nested 1 | Active Comparator | This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham. |
|
| Effects of tACS during SWS- Older Adults Active 1 | Active Comparator | This is a double cross-over with a sham control condition; the tACS administered first, then the sham |
|
| Effects of tACS during SWS- MCI Active 1 | Active Comparator | This is a cross-over with a sham control condition; the standard tACS administered first, then sham. |
|
| Effects of tACS during SWS- Standard/Nested 2 | Active Comparator | This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS. |
|
| Effects of tACS during SWS- Standard/Nested 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance | Device | Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations | Power of EEG data in microvolts within slow wave frequency range. | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Declarative Memory Encoding | Word-paired associations | Before and after each night of study session, up to 24 weeks from enrollment for each subject. |
| Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brice McConnell, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado AMC | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Effects of tACS During SWS- Standard/Nested 1 | 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. This is a triple crossover study design: standard tACS first, then nested tACS, then sham. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2019 | Jun 22, 2021 |
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This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS. |
|
| Effects of tACS during SWS- Older Adults Active 2 | Active Comparator | This is a double cross-over with a sham control condition; the sham administered first, then the tACS. |
|
| Effects of tACS during SWS- MCI Active 2 | Active Comparator | This is a cross-over with a sham control condition; the sham administered first, then standard tACS. |
|
| Effects of tACS during SWS- Standard/Nested 4 | Active Comparator | This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS. |
|
| Effects of tACS during SWS- Standard/Nested 5 | Active Comparator | This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS. |
|
| Effects of tACS during SWS- Standard/Nested 6 | Active Comparator | This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham. |
|
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 |
| Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| 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. | EEG data *No processing of data occurred to provide information about this outcome measure. | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| Change in Battery of Visuospatial Processing Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| FG001 | Effects of tACS During SWS- Standard/Nested 2 | This is a triple crossover study design: standard tACS first, then sham, then nested tACS. |
| FG002 | Effects of tACS During SWS- Standard/Nested 3 | This is a triple crossover study design: sham first, then nested tACS, then standard tACS. |
| FG003 | Effects of tACS During SWS- Standard/Nested 4 | This is a triple crossover study design: sham first, then standard tACS, then nested tACS. |
| FG004 | Effects of tACS During SWS- Standard/Nested 5 | This is a triple crossover study design: nested tACS first, then sham, then standard tACS. |
| FG005 | Effects of tACS During SWS- Standard/Nested 6 | This is a triple crossover study design: nested tACS first, then standard tACS, then sham. |
| FG006 | Effects of tACS During SWS- Older Adults Active 1 | 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. This is a crossover study design: standard tACS first, then sham. |
| FG007 | Effects of tACS During SWS- Older Adults Active 2 | This is a crossover study design: sham first, then standard tACS. |
| FG008 | Effects of tACS During SWS- MCI Active 1 | 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. This is a crossover study design: standard tACS first, then sham. |
| FG009 | Effects of tACS During SWS- MCI Active 2 | This is a crossover study design: sham first, then standard tACS. |
| COMPLETED |
|
| NOT COMPLETED |
|
Study terminated prior to completion enrollment, and prior to any enrollment of MCI arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Effects of tACS During SWS- Standard/Nested 1 | 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. This is a triple crossover: standard tACS, then nested tACS, then sham. |
| BG001 | Effects of tACS During SWS- Standard/Nested 2 | This is a triple crossover: nested tACS, then standard tACS, then sham. |
| BG002 | Effects of tACS During SWS- Standard/Nested 3 | This is a triple crossover: sham, then nested tACS, then standard tACS. |
| BG003 | Effects of tACS During SWS- Standard/Nested 4 | This is a triple crossover: sham, then standard tACS, then nested tACS |
| BG004 | Effects of tACS During SWS- Standard/Nested 5 | This is a triple crossover: nested tACS, then sham, then standard tACS |
| BG005 | Effects of tACS During SWS- Standard/Nested 6 | This is a triple crossover: nested tACS, then standard tACS, then sham. |
| BG006 | Effects of tACS During SWS- Older Adults Active 1 | 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. This is a crossover: standard tACS, then sham. |
| BG007 | Effects of tACS During SWS- Older Adults Active 2 | This is a crossover: sham, then tACS. |
| BG008 | Effects of tACS During SWS- MCI Active 1 | 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. This is a crossover: standard tACS, then sham. |
| BG009 | Effects of tACS During SWS- MCI Active 2 | This is a crossover: sham, then tACS. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations | Power of EEG data in microvolts within slow wave frequency range. | 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 | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
|
| ||||||||||||||||||||||||||||
| Secondary | Change in Declarative Memory Encoding | Word-paired associations | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject. |
| |||||||||||||||||||||||||||||
| Secondary | Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | 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. | EEG data *No processing of data occurred to provide information about this outcome measure. | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
| |||||||||||||||||||||||||||||
| Secondary | Change in Battery of Visuospatial Processing Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure. | 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 | 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. | Posted | Before and after each night of study session, up to 24 weeks from enrollment for each subject |
|
30 months (approx)
Adverse events were monitored after every period of participant data collection/study visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Effects of tACS During SWS- Standard/Nested 1 | 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. This is a triple crossover: standard tACS, then nested, then sham | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Effects of tACS During SWS- Standard/Nested 2 | This is a triple crossover: standard tACS, then sham, then nested tACS | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Effects of tACS During SWS- Standard/Nested 3 | This is a triple crossover: sham, then nested tACS, then standard tACS, | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Effects of tACS During SWS- Standard/Nested 4 | This is a triple crossover: sham, then standard tACS, then nested tACS, | 0 | 1 | 0 | 1 | 0 | 1 |
| EG004 | Effects of tACS During SWS- Standard/Nested 5 | This is a triple crossover: nested tACS, then sham, then standard tACS, | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | Effects of tACS During SWS- Standard/Nested 6 | This is a triple crossover: nested tACS, then standard tACS then sham. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG006 | Effects of tACS During SWS- Older Adults Active 1 | 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. This is a crossover: standard tACS, then sham | 0 | 9 | 0 | 9 | 0 | 9 |
| EG007 | Effects of tACS During SWS- Older Adults Active 2 | This is a crossover: sham and then standard tACS | 0 | 1 | 0 | 3 | 0 | 3 |
| EG008 | Effects of tACS During SWS- MCI Active 1 | 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. This is a crossover: standard tACS, then sham | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | Effects of tACS During SWS- MCI Active 2 | This is a crossover: sham and then standard tACS | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
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.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brice McConnell | University of Colorado | 303-724-3897 | brice.mcconnell@cuanschutz.edu |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2021 | Jun 22, 2021 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
| Effects of tACS During SWS- Older Adults Active |
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
|
This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
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This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
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This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
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This is a cross-over with a sham control condition 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. |
| OG003 | Effects of tACS During SWS- MCI Active | This is a cross-over with a sham control condition 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. |
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