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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01832740
Other study ID # Nighttime sleep-tSOS-Young
Secondary ID
Status Completed
Phase N/A
First received March 8, 2013
Last updated March 15, 2016
Start date January 2013
Est. completion date January 2015

Study information

Verified date March 2016
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The beneficial effect of nocturnal sleep on memory consolidation is well-documented 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 nocturnal SWS.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- healthy Subjects

- unobtrusive, neuropsychological screening

- age: 18-35 years

- right handed

Exclusion Criteria:

- untreated severe internal or psychiatric diseases

- epilepsy

- other severe neurological diseases eg., previous major stroke, brain tumour

- contraindications to MRI

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
brain stimulation
oscillating direct current brain stimulation
SHAM
no stimulation

Locations

Country Name City State
Germany Charite CCM Neurologie Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Diekelmann 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. Review. — View Citation

Marshall L, Helgadóttir H, Mölle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. Epub 2006 Nov 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS Retention (difference values between performance at retrieval after sleep minus performance at learning before sleep) between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task. 4 weeks No
Secondary 1. Amount of Slow wave Sleep 1. Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS. 4 weeks No
Secondary 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. 4 weeks No
Secondary 3. EEG-correlates 3. 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). 4 weeks No
Secondary 4. further memory systems 4. Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS. 4 weeks No
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