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

Not Applicable

Completed

• Conditions: Primary Insomnia
• Interventions: Device: transcranial Direct Current Stimulation

• 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

Arm && Interventions

Group	Intervention	Description
anodal stimulation	transcranial Direct Current Stimulation	10 person The patients treated by anodal stimulation (2mA) for 20 minutes
cathodal stimulation	transcranial Direct Current Stimulation	10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes
sham stimulation	transcranial Direct Current Stimulation	10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds

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
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

Trial Locations

Locations (1)

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