None listed
Conditions
Interventions
Medical Device : At Visit 1, the subjects of the clinical trial will be provided with a Sham device and applied twice a day (once in the morning (between wake-up time and noon) and once in the evening
Sponsors
LeeSol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet all of the following described conditions are selected as subjects for clinical trials. 1) A person over 40 years of age and under 80 years of age 2) A person who meets the diagnostic criteria for insomnia disorder under DSM-5 3) A person who satisfies a score of 8 or more on the Insomnia Severity Index (ISI) 4) Those with less than 30% improvement in the Insomnia Severity Index (ISI) after application of the Sham device in the period between Visit 1 and Visit 2 5) A person who voluntarily agrees to the clinical trial and is able to visit for the next observation
Exclusion criteria
Exclusion criteria: Those who meet one or more of the following described conditions are excluded from the clinical trial subjects. 1) If you are experiencing insomnia due to sleep disorders other than insomnia(hyper-sleep disorders, narcolepsy, respiratory-related sleep disorders, circadian rhythm sleep arousal disorders, incident sleep, lower limb anxiety syndrome, etc.) based on the diagnostic criteria of DSM-5 or International Classification of Sleep Disorders(ICSD-3) 2) Having insomnia due to major psychiatric disorders such as dementia, affective disorder (depression disorder, bipolar disorder), anxiety disorder, schizophrenia, etc 3) When a person suffers insomnia due to major internal medical conditions such as cerebrovascular disease, heart disease (heart failure, angina, myocardial infarction), malignant tumors, severe renal or liver dysfunction, lung disease, etc 4) Those who have changes in the type and dose of drugs that affect sleep used within the last 3 months (including prescriptions if necessary) do not fall under the exclusion criteria if the type and dose of drugs taken within the last 3 months are the same. In other words, patients taking sleeping pills can also participate in clinical trials if they are performing stable drug treatment for 3 months.) 5) hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg), arrhythmia requiring treatment or a pacemaker inserted 6) A person deemed to have other grounds for prohibition of use of clinical trial medical devices: A person who has an implantable defibrillator implanted in the body, a person who has a medical device, such as a metal implant, implanted in the head or neck 7) A person who has a history of neurological abnormalities, such as head trauma and convulsive diseases 8) a person with an infectious disease 9) A person who has symptoms of insomnia due to medication or lifestyle 10) Those who have difficulty in receiving sleep intervention (e.g., shift workers, night workers, truck drivers, long-distance bus drivers, heavy equipment drivers, etc.) 11) A person who is pregnant or is lactating or has a pregnancy plan during the main clinical trial 12) If there is any new or ongoing cognitive behavioural therapy within the last 3 months (including all other types of cognitive behavioural therapy, including insomnia) 13) A person who has attempted suicide within the last three months or is deemed to be at high risk of suicide by a psychiatrist 14) Those with a score of 29 or higher in BDI-II 15) A person who is currently participating in another clinical trial or who has participated in another clinical trial within 90 days as of the screening date 16) A person who judges that the tester is unfit to participate in the clinical trial due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) after 6 weeks compared to pre-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pittsburgh's Sleep Quality Index(PSQI) after 6 weeks compared to pre-treatment;Change in Epworth Sleepiness Scale(ESS) after 6 weeks compared to pre-treatment;Change in World Health Organization Quality of Life-BREF(WHOQOL-BREF) after 6 weeks compared to pre-treatment;Change in World Health Organization Quality of Life-BREF(WHOQOL-BREF) after 6 weeks compared to pre-treatment;Change in Sleep Efficiency(%) on the Wrist Actgraph after 6 weeks compared to pre-treatment;Changes in Wake After Sleep Onset(min) on the Wrist Actgraph after 6 weeks compared to pre-treatment;Change in Beck Depression Inventory (BDI-II) after 6 weeks compared to pre-treatment;Change in Beck Anxiety Inventory (BAI) after 6 weeks compared to pre-treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactIN YOUNG YOON
Seoul National University
Outcome results
None listed