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Completed

NCT Number: NCT02832804

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

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

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds

Other names: HDCstim (direct current stimulator)

Primary outcomes

  1. sleep log and actiwatch

    Time frame: Change from baseline at 1 week

    Changes of sleep quality

Secondary outcomes

  1. questionnaire

    Time frame: Change from baseline at 1 month

  2. EEG spectrum analysis

    Time frame: Change from baseline at 1 month

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Change from baseline at 1 month

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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