Trial Outcomes & Findings for Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (NCT NCT03112902)

Results Overview

Power of EEG data in microvolts within slow wave frequency range.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Before and after each night of study session, up to 24 weeks from enrollment for each subject

Results posted on

2021-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Effects of tACS During SWS- Standard/Nested 2 This is a triple crossover study design: standard tACS first, then sham, then nested tACS.	Effects of tACS During SWS- Standard/Nested 3 This is a triple crossover study design: sham first, then nested tACS, then standard tACS.	Effects of tACS During SWS- Standard/Nested 4 This is a triple crossover study design: sham first, then standard tACS, then nested tACS.	Effects of tACS During SWS- Standard/Nested 5 This is a triple crossover study design: nested tACS first, then sham, then standard tACS.	Effects of tACS During SWS- Standard/Nested 6 This is a triple crossover study design: nested tACS first, then standard tACS, then sham.	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.	Effects of tACS During SWS- Older Adults Active 2 This is a crossover study design: sham first, then standard tACS.
Overall Study STARTED	2	2	3	1	1	3	9	3
Overall Study COMPLETED	0	2	2	0	1	0	1	1
Overall Study NOT COMPLETED	2	0	1	1	0	3	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Effects of tACS During SWS- Standard/Nested 1 n=2 Participants 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.	Effects of tACS During SWS- Standard/Nested 2 n=2 Participants This is a triple crossover: nested tACS, then standard tACS, then sham.	Effects of tACS During SWS- Standard/Nested 3 n=3 Participants This is a triple crossover: sham, then nested tACS, then standard tACS.	Effects of tACS During SWS- Standard/Nested 4 n=1 Participants This is a triple crossover: sham, then standard tACS, then nested tACS	Effects of tACS During SWS- Standard/Nested 5 n=1 Participants This is a triple crossover: nested tACS, then sham, then standard tACS	Effects of tACS During SWS- Standard/Nested 6 n=3 Participants This is a triple crossover: nested tACS, then standard tACS, then sham.	Effects of tACS During SWS- Older Adults Active 1 n=9 Participants 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.	Effects of tACS During SWS- Older Adults Active 2 n=3 Participants This is a crossover: sham, then tACS.	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.	Effects of tACS During SWS- MCI Active 2 This is a crossover: sham, then tACS.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	17 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	12 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	12 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	23 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	22 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	3 participants n=10 Participants	9 participants n=115 Participants	3 participants n=24 Participants	—	—	24 participants n=42 Participants

PRIMARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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

Power of EEG data in microvolts within slow wave frequency range.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject.

Population: 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.

Word-paired associations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

EEG data \*No processing of data occurred to provide information about this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and after each night of study session, up to 24 weeks from enrollment for each subject

Population: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Effects of tACS During SWS- Standard/Nested 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Standard/Nested 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Standard/Nested 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Standard/Nested 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Standard/Nested 5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Standard/Nested 6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Older Adults Active 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- Older Adults Active 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- MCI Active 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effects of tACS During SWS- MCI Active 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brice McConnell

University of Colorado

Phone: 303-724-3897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place