Clinical trial NCT05546112: The Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
Official title: Pilot Study to Explore the Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Transcutaneous electric nerve stimulation, TENS
Insomnia
Trigeminal nerve stimulation
Lead sponsor: Ybrain Inc.
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2022-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the effects and safety of transcutaneous electrical nerve stimulation (TENS) at home for patients diagnosed with insomnia on the improvement of insomnia and nervous stability.


Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 19 and under 65
* Those who meet the criteria for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for Insomnia
* Those with a score of 8 or higher based on the Korean version Insomnia severity index (ISI-K)
* A person whose sleeping environment and habits are regular, usually between 9:00 p.m. and 1:00 a.m., go to bed, lie down for 7 to 10 hours, and wake up between 5 and 10 a.m.
* In the case of patients who regularly take drugs for improving insomnia at least once a week, those who agree to discontinue taking the prohibited drugs in this study for a total of 5 weeks, 1 week to remove the drug effect after screening and 4 weeks for the clinical study period
* Persons who do not have a reason to prohibit the use of electrotherapy that can significantly affect biomarkers in relation to this study
* A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial

Exclusion Criteria:

* Those who have been diagnosed with sleep arousal disorders other than insomnia (hypersomnia disorder, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep arousal disorder, parasomnia)
* Those who have insomnia due to physical illness or medications being taken
* Patients with major medical and neuropsychiatric diseases other than sleep disorders
* Persons who have had or are currently undergoing dental treatment with a history of implanting metallic materials into the upper body, such as the transcranial or face, neck, etc., where non-invasive electrical stimulation is difficult or impossible
* Compliance was evaluated by writing a sleep diary for 1 week from the start of treatment, and if a sleep diary of 3 days or less was kept for 1 week, it was excluded from the study.
* Those who have changed the type and dose of drugs used within the last 3 months, or the type and time of cognitive behavioral therapy
* If you are currently registered in another clinical trial or use another clinical trial drug or device within 60 days from the time of screening

Exclusion criteria prior to intervention (After the sleep diary for one week after the screening test, if the following criteria are met, the patient will be excluded from participation in the study before the intervention.)

* Those with less than 8 points based on the Korean version of Insomnia severity index (ISI-K)
* When writing a sleep diary for a week, if it is written for less than 3 days or has an irregular sleep schedule

Primary outcomes:
measure: Changes in Insomnia Severity Index (ISI)
timeFrame: after 4 weeks
Secondary outcomes:
measure: Remission rate of ISI
timeFrame: after 4 weeks
measure: Response rate of ISI
timeFrame: after 4 weeks
measure: Changes in Pittsburgh Slepp Quality Index (PSQI)
timeFrame: after 4 weeks
measure: Changes in index of slepp diary
timeFrame: after 4 weeks
measure: Changes in EEG index
timeFrame: after 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Changho Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: