InsomniaNCT05200897
Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia
A study testing Transdermal trigeminal electrical neuromodulation(Cefaly) in people with Insomnia and Alzheimer Disease, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Insomnia, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Transdermal trigeminal electrical neuromodulation(Cefaly)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2021to 30 Nov 2023
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mild cognitive impairment by modified Peterson's criteria
- Identified as amyloid positive by amyloid PET result
- Insomnia severity index of more than 15 or diagnosed with insomnia disorder by Diagnostic Statistical Manual-5
Who cannot join
- Subjects with active psychiatric or neurological disorders
- Unstable medical conditions (Myocardial infarction, cerebral infarction, congestive heart failures etc.)
- Moderate to severe obstructive sleep apnea (apnea hypopnea index of more than 15), rapid eye movement disorder, narcolepsy
- On regular hypnotic medication (can enroll if there was 2-week wash out period)
- Currently receiving or having a past history of cognitive behavioral therapy for insomnia
- Patients who received transcranial magnetic stimulation (TMS), transcranial direct current stimulation, within 2 weeks before enrollment
Show all 12Show fewer
- Who are on cognitive enhancers (choline alfoscerate, acetylcarnitine, acetylcholinesterase inhibitors, NMDA receptor antagonist)
- History of cerebral infarction or Parkinson's disease
- History of facial or brain trauma
- A subject with allergy to acrylic acid
- A subject who is sensitive to electrical devices
- A subject who are uncooperative to MRI process
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St.Vincent's Hospital, the Catholic University of Korea
Suwon
Se-Min Choung, 82-31-249-8459, semin9137@cmcnu.or.kr
Yoo Hyun Um, MD, PHD
About this study
Official title: Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor .
Read the detailed description
This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor . A 3-month intervention with transdermal trigeminal electrical neuromodulation will be implemented and sleep surveys, polysomnography and brain MRI will be attained both at baseline and post-intervention.
- Conditions
- Insomnia, Alzheimer Disease, Mild Cognitive Impairment, Amyloid
- Being tested
- Transdermal trigeminal electrical neuromodulation(Cefaly)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal trigeminal electrical neuromodulation(Cefaly)Device
The Cefaly device delivers electrical micro-impulses through a self-adhesive electrode which is placed over the participant's forehead, where the supratrochlear and supraorbital branches of the ophthalmic division of the trigeminal nerve are located. Rectangular, biphasic impulses with an electrical mean equal to zero are transmitted. The impulse width is 250μs, frequency is 60Hz, and the maximum intensity of 16mA is over 14 minutes
| Study group | Role | What they receive |
|---|---|---|
| Amyloid positive mild cognitive impairment+ BDNF met carrier | Experimental | Transdermal trigeminal electrical modulation for 3 months Receives: Device: Transdermal trigeminal electrical neuromodulation(Cefaly) |
| Amyloid positive mild cognitive impairment+ BDNF Val/Val | Experimental | Transdermal trigeminal electrical modulation for 3 months Receives: Device: Transdermal trigeminal electrical neuromodulation(Cefaly) |
| Amyloid negative mild cognitive impairment+ BDNF met carrier | Experimental | Transdermal trigeminal electrical modulation for 3 months Receives: Device: Transdermal trigeminal electrical neuromodulation(Cefaly) |
| Amyloid negative mild cognitive impairment+ BDNF Val/Val | Experimental | Transdermal trigeminal electrical modulation for 3 months Receives: Device: Transdermal trigeminal electrical neuromodulation(Cefaly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months
PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance
Measured: Post 3-month intervention
Changes from Baseline Insomnia severity index(ISI) at 3 months
ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity
Measured: Post 3-month intervention
Changes from Baseline Epworth sleepiness scale(ESS) at 3 months
ESS is a self-administered scale with eight questionnaires measuring sleepiness in daily life. Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.
Measured: Post-3 month intervention
Changes from Baseline Total time in bed(TIB) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Total sleep time(TST) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Sleep efficiency(SE) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Proportion of REM sleep(R, %) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline REM sleep latency(REML) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Sleep latency(SL) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Apnea-hypopnea index(AHI) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Limb movement index(LMI) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Periodic limb movement index(PLMI) at 3 months
One of polysomnography measures
Measured: Post 3-month intervention
Changes from Baseline Cortical thickness changes at 3 months
One of neuroimaging measures
Measured: Post 3-month intervention
Changes from Baseline Functional connectivity measure at 3 months
One of neuroimaging measures
Measured: Post 3-month intervention
Changes from Baseline Fractional anisotropy at 3 months
One of neuroimaging measures
Measured: Post 3-month intervention
Changes from Baseline Mean diffusivity at 3 months
One of neuroimaging measures
Measured: Post 3-month intervention
Changes from Baseline Verbal fluency at 3 months
One of cognitive measures(subtest of CERAD-K)
Measured: Post 3-month intervention
Changes from Baseline Boston naming test at 3 months
One of cognitive measures(subtest of CERAD-K)
Measured: Post 3-month intervention
Changes from Baseline Mini-mental status examination at 3 months
One of cognitive measures(subtest of CERAD-K)
Measured: Post 3-month intervention
Changes from Baseline Word list recall at 3 months
One of cognitive measures(subtest of CERAD-K)
Measured: Post 3-month intervention
Changes from Baseline Word list recognition at 3 months
One of cognitive measures(subtest of CERAD-K)
Measured: Post 3-month intervention
Changes from Baseline Constructional recall at 3 months
One of cognitive measures(subtest of CERAD-K)
Measured: Post 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start3 Nov 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoo Hyun Um, Saint Vincent's Hospital, Korea
- Investigators
- Yoo Hyun Um, Principal investigator, St.Vincent's Hospital, College of Medicine, Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200897
- Sponsor's protocol ID
- VC21DNSI0029
- Status last verified
- Nov 2023
- First submitted
- 5 Dec 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effects of Cefaly on Mild Cognitive Impairment With Insomnia and Exploration of Structural and Functional Connectivity Changes
- ClinicalTrials.gov ID
- NCT05200897
- Acronym / sponsor ID
- VC21DNSI0029
- Conditions
- Insomnia, Alzheimer Disease, Mild Cognitive Impairment, Amyloid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 21 Jan 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.
This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor .
Detailed description
This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor . A 3-month intervention with transdermal trigeminal electrical neuromodulation will be implemented and sleep surveys, polysomnography and brain MRI will be attained both at baseline and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amyloid positive mild cognitive impairment+ BDNF met carrier | Experimental | Device: Transdermal trigeminal electrical neuromodulation(Cefaly)Transdermal trigeminal electrical modulation for 3 months |
| Amyloid positive mild cognitive impairment+ BDNF Val/Val | Experimental | Device: Transdermal trigeminal electrical neuromodulation(Cefaly)Transdermal trigeminal electrical modulation for 3 months |
| Amyloid negative mild cognitive impairment+ BDNF met carrier | Experimental | Device: Transdermal trigeminal electrical neuromodulation(Cefaly)Transdermal trigeminal electrical modulation for 3 months |
| Amyloid negative mild cognitive impairment+ BDNF Val/Val | Experimental | Device: Transdermal trigeminal electrical neuromodulation(Cefaly)Transdermal trigeminal electrical modulation for 3 months |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with mild cognitive impairment by modified Peterson's criteria
- Identified as amyloid positive by amyloid PET result
- Insomnia severity index of more than 15 or diagnosed with insomnia disorder by Diagnostic Statistical Manual-5
Key exclusion criteria (12 listed)
- Subjects with active psychiatric or neurological disorders
- Unstable medical conditions (Myocardial infarction, cerebral infarction, congestive heart failures etc.)
- Moderate to severe obstructive sleep apnea (apnea hypopnea index of more than 15), rapid eye movement disorder, narcolepsy
- On regular hypnotic medication (can enroll if there was 2-week wash out period)
- Currently receiving or having a past history of cognitive behavioral therapy for insomnia
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 |
|---|---|---|
| Transdermal trigeminal electrical neuromodulation(Cefaly)The Cefaly device delivers electrical micro-impulses through a self-adhesive electrode which is placed over the participant's forehead, where the supratrochlear and supraorbital branches of the ophthalmic division of the trigeminal nerve are located. Rectangular, biphasic impulses with an electrical mean equal to zero are transmitted. The impulse width is 250μs, frequency is 60Hz, and the maximum intensity of 16mA is over 14 minutes | Device | Amyloid negative mild cognitive impairment+ BDNF Val/Val, Amyloid negative mild cognitive impairment+ BDNF met carrier, Amyloid positive mild cognitive impairment+ BDNF Val/Val, Amyloid positive mild cognitive impairment+ BDNF met carrier |
Primary outcome
Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months
Time frame: Post 3-month intervention
PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance
Changes from Baseline Insomnia severity index(ISI) at 3 months
Time frame: Post 3-month intervention
ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity
Changes from Baseline Epworth sleepiness scale(ESS) at 3 months
Time frame: Post-3 month intervention
ESS is a self-administered scale with eight questionnaires measuring sleepiness in daily life. Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.
Changes from Baseline Total time in bed(TIB) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Total sleep time(TST) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Sleep efficiency(SE) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Proportion of stage 1 sleep(N1, %) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Proportion of stage 2 sleep(N2, %) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Proportion of stage 3 sleep(N3, %) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Proportion of REM sleep(R, %) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline REM sleep latency(REML) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Sleep latency(SL) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Apnea-hypopnea index(AHI) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Limb movement index(LMI) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Periodic limb movement index(PLMI) at 3 months
Time frame: Post 3-month intervention
One of polysomnography measures
Changes from Baseline Cortical thickness changes at 3 months
Time frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Functional connectivity measure at 3 months
Time frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Fractional anisotropy at 3 months
Time frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Mean diffusivity at 3 months
Time frame: Post 3-month intervention
One of neuroimaging measures
Changes from Baseline Verbal fluency at 3 months
Time frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Boston naming test at 3 months
Time frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Mini-mental status examination at 3 months
Time frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recall at 3 months
Time frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Word list recognition at 3 months
Time frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Changes from Baseline Constructional recall at 3 months
Time frame: Post 3-month intervention
One of cognitive measures(subtest of CERAD-K)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Yoo Hyun Um principal investigator
St.Vincent's Hospital, College of Medicine, Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal trigeminal electrical neuromodulation(Cefaly) in people with Insomnia and Alzheimer Disease, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
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 3 inclusion and 12 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Yoo Hyun Um (+821063759332, cherubic712@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Pittsburgh sleep quality index(PSQI) at 3 months (time frame: Post 3-month intervention). The study lists 25 primary outcomes in all. 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 Nov 2023.