Older Adults (50-90 Years)NCT01840839
Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Older Adults
A study testing brain stimulation in people with Older Adults (50-90 Years), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults (50-90 Years)
- What is being tested?
- brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Aug 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: 50-90 years
- right handed
- inobtrusive neuropsychological examination
Who cannot join
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- dementia
- 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 Slow Wave Sleep in Older Adults
The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. This impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy subjects. If older adults that commonly experiencing cognitive decline, including long-term retention of declarative memory - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep in the same way has not been studied so far. The primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tSOS) during a daytime nap on declarative memory consolidation in older adults.
- Conditions
- Older Adults (50-90 Years)
- Being tested
- brain stimulation, Sham Stimulation
- Keywords
- aging, cognitive decline, brain stimulation, tSOS, tDCS, sleep, nap, daytime sleep, memory, memory consolidation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain stimulationDevice
Also called oscillating direct current brain stimulation
Sham StimulationDevice
Also called no stimulation
| Study group | Role | What they receive |
|---|---|---|
| 0,75 Hz stimulation | Experimental | transcranial slow oscilliating stimulation (tSOS)during periods of SWS Receives: Device: brain stimulation |
| no stimulation | Sham comparator | Sham stimulation during periods of SWS Receives: Device: Sham 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)
1. 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 spindels
2.Spindel activity during sleep indicated via several spindel 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 completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Older Adults (50-90 Years)Studies 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
- 18 participants (actual)
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, Study chair, Charite Universitätsmedizin Berlin - NeurologieAgnes Flöel, Professor, Principal investigator, Charite Universitätsmedizin Berlin - Neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840839
- Sponsor's protocol ID
- Nap-tSOS-aged
- Status last verified
- Jan 2018
- First submitted
- 18 Apr 2013
- Last updated
- 30 Jan 2018
- 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 20046194Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
PubMed 18525028Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5.
PubMed 21531243Mednick 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, Kulzow N, Passmann S, Antonenko D, Grittner U, Tamm S, Floel A. Brain stimulation during an afternoon nap boosts slow oscillatory activity and memory consolidation in older adults. Neuroimage. 2016 Nov 15;142:311-323. doi: 10.1016/j.neuroimage.2016.06.057. Epub 2016 Jul 2.
PubMed 27381076Ladenbauer 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 30 Jan 2018. 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 Slow Wave Sleep in Older Adults
- ClinicalTrials.gov ID
- NCT01840839
- Acronym / sponsor ID
- Nap-tSOS-aged
- Conditions
- Older Adults (50-90 Years)
- Keywords
- aging, cognitive decline, brain stimulation, tSOS, tDCS, sleep, nap, daytime sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 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 nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. This impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy subjects. If older adults that commonly experiencing cognitive decline, including long-term retention of declarative memory - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep in the same way has not been studied so far. The primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tSOS) during a daytime nap on declarative memory consolidation in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0,75 Hz stimulation | Experimental | Device: brain stimulationtranscranial slow oscilliating stimulation (tSOS)during periods of SWS |
| no stimulation | Sham comparator | Device: Sham StimulationSham stimulation during periods of SWS |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: 50-90 years
- right handed
- inobtrusive neuropsychological examination
Key exclusion criteria (5 listed)
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- dementia
- 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 stimulationAlso: oscillating direct current brain stimulation | Device | 0,75 Hz stimulation |
| Sham StimulationAlso: no stimulation | Device | no 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
1. Amount of Slow wave Sleep
Time frame: 4 weeks
2. sleep spindels
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 30 Jan 2018.
- 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 18525028Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
- Background: PubMed 21531243Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5.
- 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.
- Results publication: PubMed 27381076Ladenbauer J, Kulzow N, Passmann S, Antonenko D, Grittner U, Tamm S, Floel A. Brain stimulation during an afternoon nap boosts slow oscillatory activity and memory consolidation in older adults. Neuroimage. 2016 Nov 15;142:311-323. doi: 10.1016/j.neuroimage.2016.06.057. Epub 2016 Jul 2.
- 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 study chair
Charite Universitätsmedizin Berlin - Neurologie
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 in people with Older Adults (50-90 Years), 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 3 inclusion and 5 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 30 Jan 2018. 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. Some participants in this study may receive a placebo. 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 NCT01840839, which also lists 9 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 30 Jan 2018.