Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-25 @ 11:09 PM
Study NCT ID:
NCT02832804
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: