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

Not Applicable

Completed

• Conditions: Primary Insomnia

• Registration Number: NCT02832804
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2016-09-30
• Study Completion: 2017-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
sleep log and actiwatch	Change from baseline at 1 week	Changes of sleep quality

Secondary Outcome Measures

Name	Time	Method
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
questionnaire	Change from baseline at 1 month

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of