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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
Sponsor:
Information provided by (Responsible Party):
Ki-Young Jung, Seoul National University Hospital

Study Description
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Brief Summary:
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .

Condition or disease Intervention/treatment Phase
Primary Insomnia Device: transcranial Direct Current Stimulation Not Applicable

Detailed Description:

  • 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

  • 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

  • visit 7 : 1 week after treatment

    • to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
    • analysis the results of sleep log and actigraphy
    • EEG

  • visit 8 : 1 month after treatment

    • to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
    • analysis the results of sleep log
Study Design
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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
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. sleep log and actiwatch [ Time Frame: Change from baseline at 1 week ]
    Changes of sleep quality


Secondary Outcome Measures :
  1. questionnaire [ Time Frame: Change from baseline at 1 month ]
  2. EEG spectrum analysis [ Time Frame: Change from baseline at 1 month ]
  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Change from baseline at 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ki-Young Jung, professor +82-2-2072-0694 jungky10@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-Young Jung, professor    +82-2-2072-0694    jungky10@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Ki-Young Jung, professor Seoul National University Hospital
More Information
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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
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders