Clinical Study of Transcranial Electrical Stimulation for Insomnia Symptoms

Not Applicable

Recruiting

Conditions: Mental and behavioural disorders

Registration Number: KCT0009092

Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Individuals between the ages of 40 and 70 who have mild insomnia symptoms that do not meet DSM-5 diagnostic criteria for insomnia and have not received treatment (medication, cognitive behavioral therapy) for insomnia symptoms within the past year.

Exclusion Criteria

1) Meet the diagnostic criteria for insomnia disorder as set forth in the DSM-5;
2) Have received treatment (medication, cognitive behavioral therapy) for insomnia symptoms within the past year.
3) You are experiencing insomnia due to another sleep disorder (sleep apnea, restless legs, etc.);
4) suffer from insomnia due to major psychiatric disorders such as dementia, mood disorders (depressive disorder, bipolar disorder), anxiety disorders, schizophrenia, etc;
5) Insomnia due to a major internal medical condition such as cerebrovascular disease, heart disease (heart failure, angina, myocardial infarction), malignancy, severe renal or liver dysfunction, or pulmonary disease.
6) Hypotension (systolic blood pressure less than 90 or diastolic blood pressure less than 60), arrhythmia requiring treatment, or implanted pacemaker.
7) Have a history of neurological abnormalities such as head trauma, convulsive disorders, etc;
8) Individuals with infectious diseases;
9) Pregnant women

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity scale score

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index;Epworth Sleepiness Scale;Korean version of the World Health Organization Quality of Life (WHOQOL) scale;Total sleep time on the actigraphy (Total sleep time, min);Sleep efficiency on the actigraphy (Sleep efficiency, %);Wake after sleep onset on the actigraphy (Wake after sleep onset, min)