Therapeutic effect of bipolar electric low frequency electric stimulator on insomnia

Multicenter, randomized, double-blind and placebo-controlled parallel study for therapeutic efficacy and safety of low frequency electrical stimulation on insomnia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002705

Enrollment

240

Registered

2018-02-23

Start date

2017-09-04

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : The subjects will be randomly allocated to 3 arms

insomnia group with experimental treatment, insomnia group with sham device treatment, and no insomnia group with no treatment. Insomnia group with active treatment will be treated with the low frequ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with insomnia symptoms between 40 and 80 years of age who meet the diagnostic criteria for insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders Volume 5 (DSM-5).

Exclusion criteria

Exclusion criteria: A. Those who have been treated for insomnia (drug, cognitive behavior therapy, etc.) within the past year B. Those who do not meet the diagnostic criteria for insomnia disorder specified in Diagnostic and Statistical Manual of Mental Disorders, 5th ed.(DSM-5) C. In case of insomnia due to other sleep disorders such as sleep apnea syndrome or restless leg syndrome based on DSM-5 or International classification of sleep disorder (ICSD)-3 criteria D. In case of insomnia due to major psychiatric disorders such as dementia, affective disorder (depressive disorder, bipolar disorder), anxiety disorder, schizophrenia E. In case of insomnia due to major medical conditions such as cerebrovascular disease, heart disease (heart failure, angina pectoris, myocardial infarction), malignancy, severe renal insufficiency, liver dysfunction, lung disease F. Persons with a history of neurological abnormalities such as head trauma, convulsive disease G. Those with infectious disease H. Those who administer insulin injections for the treatment of diabetes I. Pregnant woman

Design outcomes

Primary

Measure	Time frame
The score of Pittsburgh Sleep Quality Index (PSQI)	—

Secondary

Measure	Time frame
Quantitative electroencephalography(QEEG);Beck depression inventory(BDI), and Beck anxiety inventory(BAI), Epworth Sleepiness Scale(ESS), Insomnia Severity Index(ISI), Quality of Life Scale Abbreviated Version(QOL-BREF);Blood Test;Heart rate variability;total sleep time, sleep efficiency and wake after sleep onset in sleep diary and actigraph	—

Countries

Korea, Republic of

Contacts

Public ContactHayun Choi

Seoul National University Bundang Hospital

chhy0402@gmail.com+82-31-787-6239

Outcome results