None listed
Conditions
Interventions
Medical Device : Intervention Objective
-The intervention is conducted to improve insomnia symptoms in patients with chronic insomnia and to evaluate the therapeutic efficacy and safety.
Investigatio
Sponsors
Neurive
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: You may participate in this clinical trial only if you meet all of the following criteria: 1. Male or female aged 19 years or older who meet the following criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD)-3: All criteria A-F must be met. A. At least one of the following must be met: 1) Difficulty initiating sleep 2) Difficulty maintaining sleep 3) Waking up too early 4) Reluctance to go to bed at an appropriate time 5) Inability to fall asleep without assistance. B. One or more of the following must be present: 1) Fatigue/lethargy 2) Attention, concentration, and memory impairment 3) Impairment in social, family, occupational, and academic performance 4) Mood disturbance and irritability 5) Daytime sleepiness 6) Behavioral disturbances (e.g., hyperactivity, obsessive-compulsive behavior, aggressive behavior) 7) Decreased energy and motivation 8) Frequent mistakes and accidents 9) Dissatisfaction with sleep C. The reported sleep/wake complaints cannot be explained solely by a lack of opportunities or environment for sleep. D. The sleep disturbance and daytime symptoms occur at least three times per week. E. The sleep disturbance and daytime symptoms have persisted for at least three months. F. The sleep disturbance and associated daytime symptoms are not attributable to another sleep disorder, medical disorder, psychiatric disorder, or drug/substance use. 2. Those who achieved a total score of 5 or higher on the Fitzerberg Sleep Quality Index (PSQI-K) questionnaire. 3. Those who understood the clinical trial and voluntarily signed the consent form.
Exclusion criteria
Exclusion criteria: If any of the following criteria apply, you cannot participate in this clinical trial. 1. Those with sleep apnea or other sleep disorders, such as restless leg syndrome, based on the diagnostic criteria of DSM-5 or ICSD (International Classification of Sleep Disorders)-3. 2. Those taking sleep-related medications for insomnia, and those whose medication type and dosage have changed or require changes within 3 months prior to the application of the clinical trial device and during the clinical trial period. (However, registration for this clinical trial is possible only if the medication type and dosage have remained unchanged for 3 months prior to the application of the clinical trial device.) 3. Those with major mental disorders, such as dementia, affective disorders (depressive disorder, bipolar disorder), alcoholism, or schizophrenia. 4. Those with major internal medical conditions, such as heart disease (heart failure, angina, myocardial infarction, arrhythmia), malignant tumors, severe renal or hepatic dysfunction, endocrine, gastrointestinal, or pulmonary diseases. 5. Those with a history or diagnosis of serious neurological abnormalities, such as head trauma or convulsive disorders. 6. Those with implantable metals, pacemakers, etc. Patients with medical devices 7. Patients with life-sustaining medical electronic devices, such as heart-lung machines 8. Patients with insomnia due to medication or lifestyle habits 9. Those receiving non-pharmacological treatments for insomnia, such as cognitive behavioral therapy (CBT-I) or light therapy 10. Those planning to travel to a time zone change during this clinical trial 11. Those currently working or planning to work night shifts or shift work during the clinical trial 12. Lactating women who are unable to sleep normally 13. Those who have taken other investigational drugs or applied investigational medical devices within the four weeks prior to screening 14. Women of childbearing potential who are pregnant or do not agree to use the contraceptive method proposed in this clinical trial 15. Those deemed unsuitable for participation in this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PSQI (Pittsburgh Sleep Quality Index) total score from before use of the clinical trial medical device (Visit 2) to 6 weeks after use (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the PSQI (Pittsburgh Sleep Quality Index) total score at 3 weeks (Visit 3) and 12 weeks (Visit 5) of use compared to before use of the clinical trial medical device (Visit 2);Changes in the total score of the Insomnia Severity Index (ISI) at 3 weeks (Visit 3), 6 weeks (Visit 4), and 12 weeks (Visit 5) of use of the clinical trial medical device compared to before use (Visit 2);Changes in WHOQOL-BREF (World Health Organization Quality of Life Assessment Instrument) scores at 3 weeks (Visit 3), 6 weeks (Visit 4), and 12 weeks (Visit 5) of use of the clinical trial medical device compared to before use (Visit 2);Changes in sleep duration at 3 weeks (visit 3), 6 weeks (visit 4), and 12 weeks (visit 5) after using the clinical trial medical device;Satisfaction score (5-Likert scale) at 12 weeks (visit 5) of using the clinical trial medical device;Compliance with medical devices for clinical trials;Vital signs;physical examination;pregnancy test;Laboratory tests;All adverse events | — |
Countries
Korea, Republic of
Contacts
Public Contacthyojin Kim
Korea University Anam Hospital
Outcome results
None listed