Healthy SubjectsNCT01840865
Effects of Brain Stimulation During Daytime Nap on Memory Consolidation in Younger, Healthy Subjects
A study testing brain stimulation and no stimulation in people with Healthy Subjects, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The beneficial effect of daytime sleep on memory consolidation has been shown in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- brain stimulation and no stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy Subjects
- unobtrusive, neuropsychological screening
- age: 18-35 years
- right handed
Who cannot join
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Daytime Slow Wave Sleep in Younger, Healthy Subjects
The beneficial effect of daytime sleep on memory consolidation has been shown in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. In this study we investigate if the consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during daytime SWS.
- Conditions
- Healthy Subjects
- Being tested
- brain stimulation, no stimulation
- Keywords
- young healthy subjects, brain stimulation, tSOS, tDCS, sleep, daytime sleep, nap, memory, memory consolidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain stimulationDevice
oscillating direct current brain stimulation
no stimulationDevice
sham Stimulation
| Study group | Role | What they receive |
|---|---|---|
| SHAM stimulation | Experimental | SHAM stimulation during periods of Slow Wave Sleep Receives: Device: no stimulation |
| 0,75 Hz stimulation | Experimental | slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep Receives: Device: brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
Measured: 4 weeks
Secondary outcomes (4)
Amount of Slow wave Sleep
- Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.
Measured: 4 weeks
2. sleep spindles
- Spindle activity during sleep indicated via several spindle parameters like number, duration, frequency of spindles; compared between 0,75 Hz and SHAM stimulation during SWS.
Measured: 4 weeks
3. EEG-correlates
- Neuronal correlates (EEG-power in slow oscillation frequency bands induced by 0,75 Hz vs SHAM stimulation during SWS; EEG-correlates of encoding and retrieval of a declarative memory task).
Measured: 4 weeks
4. further memory systems
- Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Flöel, Professor, Principal investigator, Charite Universitätsmedizin Berlin - Neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840865
- Sponsor's protocol ID
- Nap-tSOS-young
- Status last verified
- Mar 2016
- First submitted
- 18 Apr 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
PubMed 17086200Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
PubMed 20046194Mednick SC, Cai DJ, Kanady J, Drummond SP. Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory. Behav Brain Res. 2008 Nov 3;193(1):79-86. doi: 10.1016/j.bbr.2008.04.028. Epub 2008 May 8.
PubMed 18554731Mander BA, Santhanam S, Saletin JM, Walker MP. Wake deterioration and sleep restoration of human learning. Curr Biol. 2011 Mar 8;21(5):R183-4. doi: 10.1016/j.cub.2011.01.019. No abstract available.
PubMed 21377092Mednick S, Nakayama K, Stickgold R. Sleep-dependent learning: a nap is as good as a night. Nat Neurosci. 2003 Jul;6(7):697-8. doi: 10.1038/nn1078.
PubMed 12819785Ladenbauer J, Ladenbauer J, Kulzow N, Floel A. Memory-relevant nap sleep physiology in healthy and pathological aging. Sleep. 2021 Jul 9;44(7):zsab002. doi: 10.1093/sleep/zsab002.
PubMed 33406266
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Daytime Slow Wave Sleep in Younger, Healthy Subjects
- ClinicalTrials.gov ID
- NCT01840865
- Acronym / sponsor ID
- Nap-tSOS-young
- Conditions
- Healthy Subjects
- Keywords
- young healthy subjects, brain stimulation, tSOS, tDCS, sleep, daytime sleep, nap, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The beneficial effect of daytime sleep on memory consolidation has been shown in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. In this study we investigate if the consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during daytime SWS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHAM stimulation | Experimental | Device: no stimulationSHAM stimulation during periods of Slow Wave Sleep |
| 0,75 Hz stimulation | Experimental | Device: brain stimulationslow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy Subjects
- unobtrusive, neuropsychological screening
- age: 18-35 years
- right handed
Key exclusion criteria (4 listed)
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brain stimulationoscillating direct current brain stimulation | Device | 0,75 Hz stimulation |
| no stimulationsham Stimulation | Device | SHAM stimulation |
Primary outcome
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Time frame: 4 weeks
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
4 secondary outcomes
Amount of Slow wave Sleep
Time frame: 4 weeks
2. sleep spindles
Time frame: 4 weeks
3. EEG-correlates
Time frame: 4 weeks
4. further memory systems
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 17086200Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
- Background: PubMed 20046194Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
- Background: PubMed 18554731Mednick SC, Cai DJ, Kanady J, Drummond SP. Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory. Behav Brain Res. 2008 Nov 3;193(1):79-86. doi: 10.1016/j.bbr.2008.04.028. Epub 2008 May 8.
- Background: PubMed 21377092Mander BA, Santhanam S, Saletin JM, Walker MP. Wake deterioration and sleep restoration of human learning. Curr Biol. 2011 Mar 8;21(5):R183-4. doi: 10.1016/j.cub.2011.01.019. No abstract available.
- Background: PubMed 12819785Mednick S, Nakayama K, Stickgold R. Sleep-dependent learning: a nap is as good as a night. Nat Neurosci. 2003 Jul;6(7):697-8. doi: 10.1038/nn1078.
- Derived from this study: PubMed 33406266Ladenbauer J, Ladenbauer J, Kulzow N, Floel A. Memory-relevant nap sleep physiology in healthy and pathological aging. Sleep. 2021 Jul 9;44(7):zsab002. doi: 10.1093/sleep/zsab002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Flöel, Professor principal investigator
Charite Universitätsmedizin Berlin - Neurologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brain stimulation and no stimulation in people with Healthy Subjects, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840865, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.