Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
1 other identifier
interventional
8
1 country
1
Brief Summary
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedSeptember 24, 2021
September 1, 2021
8 months
April 18, 2016
September 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
sleep log and actiwatch
Changes of sleep quality
Change from baseline at 1 week
Secondary Outcomes (3)
questionnaire
Change from baseline at 1 month
EEG spectrum analysis
Change from baseline at 1 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Change from baseline at 1 month
Study Arms (3)
anodal stimulation
EXPERIMENTAL10 person The patients treated by anodal stimulation (2mA) for 20 minutes
cathodal stimulation
ACTIVE COMPARATOR10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes
sham stimulation
SHAM COMPARATOR10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds
Interventions
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
Eligibility Criteria
You may qualify if:
- adult (older than 19 years)
- primary insomnia
- right handed
- agree with participation of this study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ki-Young Jung, professor
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 18, 2016
First Posted
July 14, 2016
Study Start
February 1, 2016
Primary Completion
September 30, 2016
Study Completion
May 1, 2017
Last Updated
September 24, 2021
Record last verified: 2021-09