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Effectiveness of Cranial Electrotherapy Stimulation on Subjects with Insomnia Symptoms

Effectiveness of Cranial Electrotherapy Stimulation on Subjects with Insomnia Symptoms: A Randomized, Double-blind and Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006962
Enrollment
80
Registered
2022-01-26
Start date
2019-12-13
Completion date
Unknown
Last updated
2022-02-07

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

Conditions

None listed

Interventions

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: People aged between 20 and 59 with mild insomnia symtpoms that do not severe enough to meet the diagnostic criteria of insomnia disorder based on DSM-5 and without receiving any pharmacological or non-pharmacological treatment within one year

Exclusion criteria

Exclusion criteria: 1) people currently diagnosed as insomnia disorder based on DSM-5 2) people who have recieved any pharmacological or non-pharmacological treatment within one year 3) people with other sleep disorders such as sleep apnea, restless leg syndrome which may explain sleep disturbance 4) people with neuropsychiatric disorders such dementia, mood disorder, anxiety disorder, schizophrenia which may explain sleep disturbance 5) people with cerebrovascular disease, severe heart disease (i.e., heart failure, angina, myocardial infarction), malignancy, kidney or liver failure, or lung disease which may explain sleep disturbance 6) people with low blood pressure (systolic blood pressure less than 90 or diastolic blood pressure less than 60), arrthymia needed to be treated, or pacemaker 7) people with history of head trauma, epilesy, or other neurologic diseases 8) people currently with infectious disease 9) pregnant women

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index-Korean (PSQI-K);objective total sleep time measured by actigraphy

Secondary

MeasureTime frame
Insomnia Severity Index-Korean (ISI-K);Scores for depression of Hospital anxiety and depression scale (HADS);Scores for anxiety of Hospital anxiety and depression scale (HADS);Quality of Life scale, abbreviated version edited by World Health Organization (WHOQOL-BREF) ;objective sleep efficiency measured by actigraphy ;Alpha activity

Countries

Korea, Republic of

Contacts

Public ContactJung Kyung Hong

Seoul National University Bundang Hospital

koalalalala2@gmail.com+82-2-787-7439

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026