Pupil DiameterNCT06790459
Effects of the Ultra-low Frequencies TENS on the Arousal Circuits
A study testing UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation) in people with Pupil Diameter and Arousal, run by University of L'Aquila at 1 site in Italy.
Trial summary
Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pupil Diameter, Arousal
- What is being tested?
- UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 24 Sep 2024to 30 Oct 2024
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health status and physical fitness
- female sex
- age between 20 and 30 years
- non-smoker
- no more than 3 espresso coffees per day
- no intake of stimulant or psychotropic drugs in general
- body mass index between 18.5 and 24.9
Who cannot join
- presence of acute and/or chronic cardiocirculatory and respiratory disorders
- metabolic and autonomic system disorders
- intake of peripheral and central nervous system excitatory or inhibiting substances
- presence of generalized anxiety and/or panic attacks, or mood disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transmucosal Electrical Tongue Stimulation (TUD) on Tonic Pupil Size in the Dark
Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive effects. However, no studies have examined the effect of stimulation of the anterior mucosa of the tongue on pupil size as an indicator of arousal. The aim of this study will be to evaluate the effect of ULFTENS stimulation on pupil size in the dark.
Read the detailed description
Changes in pupil size are indicative of the activity of the noradrenergic system, with pupil dilation associated with a higher state of arousal. According to various studies, odontological ULFTENS, through trigeminal stimulation, can help rebalance this altered system with positive effects. Our goal is to harness the capabilities of ULFTENS by stimulating the dorsal lingual mucosa and evaluating its effects on pupil size in the dark. Healthy women aged between 20 and 30 will be recruited and divided into two groups: a control group and an experimental group. Participants in the control group will lie down on a bed with their eyes closed, and will then be asked to open their eyes without moving their eyelids. Pupil diameter will be measured using a pupillometer for 15 seconds. This procedure will be repeated twice. The experimental group will receive a tongue stimulator connected to the ULFTENS, which will be activated after the first measurement. The stimulation will last approximately 15 minutes, with a second measurement taken after 15 seconds. At the end of the stimulation, the final measurement will be taken. The goal is to measure the pupil diameter of both eyes at the three time points and compare the results between the two groups to assess the effect of the stimulator on arousal circuits.
- Conditions
- Pupil Diameter, Arousal
- Being tested
- UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)
- Keywords
- Pupil size, ULFTENS, Trigeminal electrical stimulation, tongue stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)Device
ULFTENS device will be administered in the experimental group for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 20 women of 20-30 years would be enrolled to the experimental group. They will undergone to tongue stimulation with ULFTENS device for 15 minutes. Pupils' diameter will be measure for three time points, before, during and after the tongue stimulation Receives: Device: UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation) |
| Control group | No intervention | 20 women of 20-30 years will be enrolled to the control group. Their pupils' diameter will be measure at three time points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil size
left and right pupils diameter will be measured using a pupillometry. Images of the pupils will be acquired by the Oculus system, using two infrared CCD cameras (resolution 720 × 576 pixels, 256 grey levels) mounted on a light helmet (1.5 kg), with sampling frequency of 25 frame/s. The eyes will be illuminated with an infrared diode with 880 nm of wave length.
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start24 Sep 2024
- Primary completion2 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pupil DiameterStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Di Nicolantonio, University of L'Aquila
- Investigators
- Annalisa Monaco, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790459
- Sponsor's protocol ID
- University of L'Aquila
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monaco A, Cattaneo R, Smurra P, Di Nicolantonio S, Cipriano F, Pietropaoli D, Ortu E. Trigeminal electrical stimulation with ULFTENS of the dorsal anterior mucosal surface of the tongue: Effects on Heart Rate Variability (HRV). PLoS One. 2023 May 10;18(5):e0285464. doi: 10.1371/journal.pone.0285464. eCollection 2023.
PubMed 37163499Monaco A, Cattaneo R, Di Nicolantonio S, Strada M, Pietropaoli D, Ortu E. Effects of trigeminal neurostimulation on heart rate variability: comparing cutaneous (Tragus) and tongue (Antero-Dorsal mucosa) stimulation. BMC Oral Health. 2024 Oct 20;24(1):1257. doi: 10.1186/s12903-024-04914-2.
PubMed 39428464
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transmucosal Electrical Tongue Stimulation (TUD) on Tonic Pupil Size in the Dark
- ClinicalTrials.gov ID
- NCT06790459
- Acronym / sponsor ID
- University of L'Aquila
- Conditions
- Pupil Diameter, Arousal
- Keywords
- Pupil size, ULFTENS, Trigeminal electrical stimulation, tongue stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 24 Jan 2025 (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.
Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive effects. However, no studies have examined the effect of stimulation of the anterior mucosa of the tongue on pupil size as an indicator of arousal. The aim of this study will be to evaluate the effect of ULFTENS stimulation on pupil size in the dark.
Detailed description
Changes in pupil size are indicative of the activity of the noradrenergic system, with pupil dilation associated with a higher state of arousal. According to various studies, odontological ULFTENS, through trigeminal stimulation, can help rebalance this altered system with positive effects. Our goal is to harness the capabilities of ULFTENS by stimulating the dorsal lingual mucosa and evaluating its effects on pupil size in the dark. Healthy women aged between 20 and 30 will be recruited and divided into two groups: a control group and an experimental group. Participants in the control group will lie down on a bed with their eyes closed, and will then be asked to open their eyes without moving their eyelids. Pupil diameter will be measured using a pupillometer for 15 seconds. This procedure will be repeated twice. The experimental group will receive a tongue stimulator connected to the ULFTENS, which will be activated after the first measurement. The stimulation will last approximately 15 minutes, with a second measurement taken after 15 seconds. At the end of the stimulation, the final measurement will be taken. The goal is to measure the pupil diameter of both eyes at the three time points and compare the results between the two groups to assess the effect of the stimulator on arousal circuits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)20 women of 20-30 years would be enrolled to the experimental group. They will undergone to tongue stimulation with ULFTENS device for 15 minutes. Pupils' diameter will be measure for three time points, before, during and after the tongue stimulation |
| Control group | No intervention | –20 women of 20-30 years will be enrolled to the control group. Their pupils' diameter will be measure at three time points |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- good health status and physical fitness
- female sex
- age between 20 and 30 years
- non-smoker
- no more than 3 espresso coffees per day
Key exclusion criteria (4 listed)
- presence of acute and/or chronic cardiocirculatory and respiratory disorders
- metabolic and autonomic system disorders
- intake of peripheral and central nervous system excitatory or inhibiting substances
- presence of generalized anxiety and/or panic attacks, or mood disorders.
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 |
|---|---|---|
| UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)ULFTENS device will be administered in the experimental group for 15 minutes | Device | Experimental group |
Primary outcome
Pupil size
Time frame: 12 minutes
left and right pupils diameter will be measured using a pupillometry. Images of the pupils will be acquired by the Oculus system, using two infrared CCD cameras (resolution 720 × 576 pixels, 256 grey levels) mounted on a light helmet (1.5 kg), with sampling frequency of 25 frame/s. The eyes will be illuminated with an infrared diode with 880 nm of wave length.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 37163499Monaco A, Cattaneo R, Smurra P, Di Nicolantonio S, Cipriano F, Pietropaoli D, Ortu E. Trigeminal electrical stimulation with ULFTENS of the dorsal anterior mucosal surface of the tongue: Effects on Heart Rate Variability (HRV). PLoS One. 2023 May 10;18(5):e0285464. doi: 10.1371/journal.pone.0285464. eCollection 2023.
- Results publication: PubMed 39428464Monaco A, Cattaneo R, Di Nicolantonio S, Strada M, Pietropaoli D, Ortu E. Effects of trigeminal neurostimulation on heart rate variability: comparing cutaneous (Tragus) and tongue (Antero-Dorsal mucosa) stimulation. BMC Oral Health. 2024 Oct 20;24(1):1257. doi: 10.1186/s12903-024-04914-2.
- Individual participant dataSharing planned: No
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.
Annalisa Monaco principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation) in people with Pupil Diameter and Arousal, run by University of L'Aquila at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 24 Jan 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil size (time frame: 12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790459, which also lists 2 linked publications.
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 24 Jan 2025.