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NCT02832804 Clinical Trial

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

Primary Insomnia Clinical Trial

Official title:
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02832804
Other study ID # 1509-061-703
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date May 2017

Study information
Verified date September 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date May 2017
Est. primary completion date September 30, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary sleep log and actiwatch Changes of sleep quality Change from baseline at 1 week
Secondary questionnaire Change from baseline at 1 month
Secondary EEG spectrum analysis Change from baseline at 1 month
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability Change from baseline at 1 month
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