Effectiveness of Cranial Electrotherapy Stimulation on Subjects with Stress Symptoms

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007714

Enrollment

Registered

2022-09-19

Start date

2021-03-11

Completion date

Unknown

Last updated

2022-10-24

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

Conditions

None listed

Interventions

Others(Low risk devices intended for general wellness) : Devices: Sleepisol®. This device delivers micro-currency through two frontal electrodes to brain as Cranial Electrotherapy Stimulation (CES).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: People aged between 19 and 65 with stress symptoms that do not severe enough to meet the diagnostic criteria of major psychiatric disorder based on DSM-5 and without receiving any pharmacological or non-pharmacological treatment within one year

Exclusion criteria

Exclusion criteria: (1) history of neurological deficit (dementia, brain injury, seizure disorder) (2) presence of major psychiatric disorder (3) persons with acute stress (death of family, restraint, divorce, separation, debt, delinquency, affair, business failure, serious illness, marriage, etc.) within 4 weeks (4) receiving cognitive behavioral therapy, biofeedback, neurofeedback, or meditation therapy within 1 year (5) taking psychiatric drugs, oral steroids or corticosteroids within 4 weeks.

Design outcomes

Primary

Measure	Time frame
Perceived stress scale ;Salivary cortisol arousal response	—

Secondary

Measure	Time frame
Insomnia Severity Index-Korean (ISI-K);Beck depression inventory - II;State-trait anxiety inventory-state anxiety;Pittsburgh Sleep Quality Index;Quality of Life scale abbreviated version;Salivary alpha-amylase arousal;Diurnal cortisol slope;Diurnal alpha amylase slope;Quantitative electroencephalogram;Salivary cortisol concentration;Salivary alpha amylase concentration	—

Countries

Korea, Republic of

Contacts

Public ContactIn-Young Yoon

Seoul National University Bundang Hospital

netu4@naver.com+82-31-787-6244

Outcome results