Clinical Study of Transcranial Electrical Stimulation for Insomnia Symptoms

Effectiveness of Transcranial Alternating Electrical Stimulation Devices (CS-01) on Subjects with Insomnia Symptoms: A Randomized, Double-blind and Controlled Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009092

Enrollment

Registered

2024-01-05

Start date

2023-07-11

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Transcranial Alternating Electrical Stimulation Devices ) : After receiving written informed consent, subjects will wear a headband-type cranial electrostimulation device for 6 weeks and will b

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Insomnia severity scale score	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactSeock Hyeon Moon

Seoul National University Bundang Hospital

lovehuntter@naver.com+82-31-787-6079

Outcome results