None listed
Conditions
Interventions
Medical Device : Purpose of Intervention
-The study aims to improve sleep quality in patients with chronic insomnia and evaluate the therapeutic efficacy and safety of the intervention.
Intervention D
Sponsors
Neurive
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be included in this clinical trial: 1) Men or women aged 19 years or older who meet the DSM-5 criteria for chronic insomnia: A. Dissatisfaction with sleep quantity or quality, associated with one or more of the following symptoms: 1.Difficulty initiating sleep. 2.Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after waking up. 3.Early morning awakening with difficulty returning to sleep. B. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. C. Sleep difficulty occurs at least three times per week. D. Sleep difficulty persists for at least three months. E. Sleep difficulty occurs despite adequate opportunity for sleep. F. The insomnia is not better explained by another sleep-wake disorder (e.g., narcolepsy, breathing-related sleep disorder, circadian rhythm sleep-wake disorder, or parasomnia) and does not occur exclusively during the course of such disorders. G. The insomnia is not attributable to the physiological effects of a substance (e.g., a drug of abuse or medication). H. Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia. 2) Participants must have a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher. 3) Participants must provide written informed consent after understanding and agreeing to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: Participants will be excluded from this clinical trial if they meet any of the following conditions: 1) Individuals diagnosed with other sleep disorders, such as sleep apnea or restless legs syndrome, based on DSM-5 or International Classification of Sleep Disorders (ICSD)-3 criteria. 2) Individuals with major psychiatric disorders, including dementia, mood disorders (e.g., major depressive disorder, bipolar disorder), alcohol dependence, or 3) schizophrenia. 3) Individuals with significant internal medical conditions, such as cardiovascular disease (e.g., heart failure, angina, myocardial infarction, arrhythmia), malignancies, severe renal or hepatic dysfunction, or significant endocrine, gastrointestinal, or pulmonary diseases. 4) Individuals with confirmed or a history of serious neurological abnormalities, including head trauma or seizure disorders. 5) Patients with implanted metal devices or cardiac pacemakers. 6) Patients with life-supporting electronic medical devices, such as artificial cardiopulmonary devices. 7) Individuals whose insomnia is caused by medications or lifestyle habits. 8) Pregnant women or women of childbearing potential who do not agree to use effective contraception during the clinical trial. 9) Individuals deemed unsuitable for participation in this clinical trial at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of PSQI Change (Pittsburgh Sleep Quality Index, Sleep Quality Score), A score obtained by summing the responses to a 9-item questionnaire designed to assess sleep quality | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of PSQI Change (Pittsburgh Sleep Quality Index, Sleep Quality Score), a score obtained by summing the responses to a 9-item questionnaire designed to assess sleep quality.;Comparison of ISI Score Changes (Insomnia Severity Index), a score obtained by summing the responses to a 5-item questionnaire designed to measure the severity of insomnia.;Comparison of WHOQOL-BREF Score Changes (World Health Organization Quality of Life-BREF), a score obtained by summing the responses to a 26-item questionnaire designed to assess overall quality of life.;Comparison of Total Sleep Time Changes (minutes);Satisfaction Questionnaire (score): Participants will record their satisfaction using a 5-point Likert scale for each item, including the ease of use and pain tolerance of Soricle. | — |
Countries
Korea, Republic of
Contacts
Public Contacthyojin Kim
Korea University Anam Hospital
Outcome results
None listed