InsomniaNCT05546112
The Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
A study testing Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B in people with Insomnia, run by Ybrain Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Explore the Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
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.
- Conditions
- Insomnia
- Being tested
- Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B, Sham Stimulation using YPS-401B
- Keywords
- Transcutaneous electric nerve stimulation, TENS, Insomnia, Trigeminal nerve stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401BDevice
A device that improves insomnia symptoms by transcutaneously applying electrical stimulation including a pulse (10 kHz) burst waveform (10 Hz) to the forehead area to the trigeminal nerve
Sham Stimulation using YPS-401BDevice
A device that is attached in the same way as a real medical device, but actually applies a shum stimulus
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Transcutaneous trigeminal nerve stimulation applied using clinical trial medical device (YPS-401B) for 20 minutes every night before going to bed, 28 times for 4 weeks at 1 time / 1 day Receives: Device: Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B |
| Control group | Sham comparator | Sham stimulation applied using clinical trial medical device (YPS-401B) for 20 minutes every night before going to bed, 28 times for 4 weeks at 1 time / 1 day Receives: Device: Sham Stimulation using YPS-401B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insomnia Severity Index (ISI)
Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment:
Measured: after 4 weeks
Secondary outcomes (5)
Remission rate of ISI
Remission rate of ISI after 4 weeks compared to before treatment (Remission: ISI score of 7 or less)
Measured: after 4 weeks
Response rate of ISI
Response rate of ISI after 4 weeks compared to before treatment (Response: ISI change of more than 7 points or 50% or more decrease)
Measured: after 4 weeks
Changes in Pittsburgh Slepp Quality Index (PSQI)
Changes in Pittsburgh Slepp Quality Index (PSQI) after 4 weeks compared to before treatment
Measured: after 4 weeks
Changes in index of slepp diary
Changes in index of sleep diary (sleep latency, bedtime, sleep time) after 4 weeks compared to before treatment
Measured: after 4 weeks
Changes in EEG index
Changes in EEG index (absolute power, relative power) after 4 weeks compared to before treatment
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start4 Oct 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ybrain Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Sponsor
- Investigators
- Changho Yoon, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546112
- Sponsor's protocol ID
- YB-05
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Explore the Efficacy and Safety of At-home Transcutaneous Electrical Nerve Stimulation in Insomnia
- ClinicalTrials.gov ID
- NCT05546112
- Acronym / sponsor ID
- YB-05
- Conditions
- Insomnia
- Keywords
- Transcutaneous electric nerve stimulation, TENS, Insomnia, Trigeminal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ybrain Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 4 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401BTranscutaneous trigeminal nerve stimulation applied using clinical trial medical device (YPS-401B) for 20 minutes every night before going to bed, 28 times for 4 weeks at 1 time / 1 day |
| Control group | Sham comparator | Device: Sham Stimulation using YPS-401BSham stimulation applied using clinical trial medical device (YPS-401B) for 20 minutes every night before going to bed, 28 times for 4 weeks at 1 time / 1 day |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401BA device that improves insomnia symptoms by transcutaneously applying electrical stimulation including a pulse (10 kHz) burst waveform (10 Hz) to the forehead area to the trigeminal nerve | Device | Experimental group |
| Sham Stimulation using YPS-401BA device that is attached in the same way as a real medical device, but actually applies a shum stimulus | Device | Control group |
Primary outcome
Changes in Insomnia Severity Index (ISI)
Time frame: after 4 weeks
Changes in Insomnia Severity Index (ISI) after 4 weeks from pretreatment:
5 secondary outcomes
Remission rate of ISI
Time frame: after 4 weeks
Response rate of ISI
Time frame: after 4 weeks
Changes in Pittsburgh Slepp Quality Index (PSQI)
Time frame: after 4 weeks
Changes in index of slepp diary
Time frame: after 4 weeks
Changes in EEG index
Time frame: after 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changho Yoon, MD, PhD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Trigeminal Electrical Nerve Stimulation using YPS-401B in people with Insomnia, run by Ybrain Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiwon Lee, PhD (+82-535-2871, clinical.trials@ybrain.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity Index (ISI) (time frame: after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.