Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
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ClinicalTrials.gov Identifier: NCT02832804 |
Recruitment Status : Unknown
Verified February 2016 by Ki-Young Jung, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : July 14, 2016
Last Update Posted : July 15, 2016
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Condition or disease | Intervention/treatment | Phase |
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Primary Insomnia | Device: transcranial Direct Current Stimulation | Not Applicable |
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visit 1
- to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)
- EEG
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visit 2-6
- tDCS stimulation (monday ~ friday)
- anodal / cathodal / sham
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
- analysis the results of sleep log and actigraphy
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visit 7 : 1 week after treatment
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
- analysis the results of sleep log and actigraphy
- EEG
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visit 8 : 1 month after treatment
- to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
- analysis the results of sleep log
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients |
Study Start Date : | February 2016 |
Estimated Primary Completion Date : | May 2017 |
Estimated Study Completion Date : | June 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: anodal stimulation
10 person The patients treated by anodal stimulation (2mA) for 20 minutes
|
Device: transcranial Direct Current Stimulation
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
Other Name: HDCstim (direct current stimulator) |
Active Comparator: cathodal stimulation
10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes
|
Device: transcranial Direct Current Stimulation
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
Other Name: HDCstim (direct current stimulator) |
Sham Comparator: sham stimulation
10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds
|
Device: transcranial Direct Current Stimulation
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
Other Name: HDCstim (direct current stimulator) |
- sleep log and actiwatch [ Time Frame: Change from baseline at 1 week ]Changes of sleep quality
- questionnaire [ Time Frame: Change from baseline at 1 month ]
- EEG spectrum analysis [ Time Frame: Change from baseline at 1 month ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Change from baseline at 1 month ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult (older than 19 years)
- primary insomnia
- right handed
- agree with participation of this study
Exclusion Criteria:
- diagnosed with epilepsy or history of seizure
- change of antipsychotic drug within 1 month
- under suspicion of sleep apnea or periodic limb movement disorder
- mental retardation (IQ < 70)
- pregnant woman

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832804
Contact: Ki-Young Jung, professor | +82-2-2072-0694 | jungky10@gmail.com |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Ki-Young Jung, professor +82-2-2072-0694 jungky10@gmail.com |
Study Chair: | Ki-Young Jung, professor | Seoul National University Hospital |
Responsible Party: | Ki-Young Jung, professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT02832804 |
Other Study ID Numbers: |
1509-061-703 |
First Posted: | July 14, 2016 Key Record Dates |
Last Update Posted: | July 15, 2016 |
Last Verified: | February 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |