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Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

anodal stimulation

cathodal stimulation

sham stimulation

Arm Description

10 person The patients treated by anodal stimulation (2mA) for 20 minutes

10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes

10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds

Outcomes

Primary Outcome Measures

sleep log and actiwatch
Changes of sleep quality

Secondary Outcome Measures

questionnaire
EEG spectrum analysis
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

First Posted
April 18, 2016
Last Updated
September 23, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02832804
Brief Title
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
Official Title
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal stimulation
Arm Type
Experimental
Arm Description
10 person The patients treated by anodal stimulation (2mA) for 20 minutes
Arm Title
cathodal stimulation
Arm Type
Active Comparator
Arm Description
10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation
Other Intervention Name(s)
HDCstim (direct current stimulator)
Intervention Description
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
Primary Outcome Measure Information:
Title
sleep log and actiwatch
Description
Changes of sleep quality
Time Frame
Change from baseline at 1 week
Secondary Outcome Measure Information:
Title
questionnaire
Time Frame
Change from baseline at 1 month
Title
EEG spectrum analysis
Time Frame
Change from baseline at 1 month
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Change from baseline at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Young Jung, professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients

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