Primary Insomnia Clinical Trial
Official title:
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
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 |
Verified date | September 2021 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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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